> The FDA approval comes based on trial data submitted by the pharmaceutical company, so it's worth noting that published peer-reviewed reports are yet to be published. Peer-reviewed publications often follow regulatory approvals, not precede them, which is common in the field of ophthalmology and dermatology.
Does anyone know the reason that data is published after approval rather than before? Seems illogical at face value, but I'm obviously missing something.
Short answer: FDA is totally toothless these days after decades of industry lobbying and Republican budget cuts. The industry has decided how they want things to work.
And you're thinking this ability to bypass scrutiny must lead to problems.
Correct. When liabilities grow too big, the company will spin off the liabilities to a shell company without means to pay for damages caused.
(this is called a "Texas two-step" bankruptcy)
Please spend 30 seconds to search whether the fda budget has actually been cut over time (hint: it hasn’t)
The fda budget much like every other agency has grown incredibly in the last 50 years ( <1bnin 1992 to >6bn today). You can look at more recent numbers and see it’s still rising. When you hear cuts I’m spending it’s often cuts in proposed increases in spending which are often double digits. So you can grow an agency 10% a year for decades and then a single slow down or reversion to levels from just a year or two ago is seen as drastic cuts that will result in poison into our water.
You're not wrong about funding, but OP is correct about industry influence.
It varies a little by division/subject matter, but they basically have to run everything by industry and are subject to FOIAs and public shaming by senators and representatives beholden to industry.
Source: long-term partner of FDA employee, though this stuff is pretty widely understood.
>Short answer: FDA is totally toothless these days after decades of industry lobbying and Republican budget cuts.
The funny thing about short answers is that they're often partly or wholly full of shit and don't describe the underlying reality. For example, see how different things get when you look at actual information instead of pulling ideological talking points out of your ass without knowing what the hell is even the case? (A common thing on this site among so many self-described highly intelligent people)
This is the FDA's actual funding history over the last 3 decades (page 6 of the PDF), showing a steadily increasing budget across both Republican and Democrat admins. Curiously, some of its bigger budget increases coincided with the first Trump administration even. https://sgp.fas.org/crs/misc/R44576.pdf
You can educate yourself on the FDA process, including public access to all the FDA documentation, including meeting minutes and sponsorship slides. It’s all there on fda.gov
But instead of doing that you’ve decided to just write this comment instead and post something that looks quite silly for those that have taken the first approach.
When you navigate to the Clinical Trials section[1], the "View Clinical Trials Guidance Document" link[2] currently stalls, and then gives a 403 error page that says "Page Not Found". All of the information is not there on fda.gov, and whoever's in charge is doing a very sloppy job.
The claim that “the industry has decided how they want things to work” is laughable.
The numerous “not approved” decisions makes that plainly obvious. Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.
To the question at hand “why do publications come after FDA approval”, the FDA has access to all the data (actually more) before publication, so the publication is irrelevant to approval.
> Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.
The company happily complies?
Or just does it begrudgingly because not doing it delays sales a few more quarters if not indefinitely?
I'm not sure where you're getting the idea from that a company would happily do anything additional. It's a cost of doing business. Let's not pretend they're angels, they're in it for the money not the greater good.
And if that last statement needs a rationale, tell me who is doing the work to find the next antibiotic or any other non chronic disease medication
I'm pretty sure any certain path to approval makes the company happy. Ecstatic, even. They get to move the drug from the liabilities to the asset column of their ledger.
I took issue with the happy part because it's a regulator not a customer kindly asking for a change.
Even if the cost of the change are very high, getting it approved is probably worthwhile. To say that they would do so happily implies that there's a motive beyond getting approval.
Based on these comments, maybe my interpretation was just off
> after decades of industry lobbying and Republican budget cuts
If only the Democrats had been in power in that period. And if only lobbying weren't something that was impossible to prevent by a neutral third party paid for by taxes to do exactly that.
It’s because the publishing process takes more time than the FDA review process.
Once the pivotal trial reads out, companies usually submit within a month or two to the FDA. Much of the submission dossier (trial design, product description) can be written ahead of time, so it’s really the results that need to be drafted.
The FDA can approve in as little as 3-4 months for an accelerated approval, but it can take up to 12 months.
Compare that with a paper being written and reviewed across multiple authors (3-6 months if you’re lucky), then submitting to multiple journals for review and feedback (6 months), then final submission and peer review (1-2 months), then any additional edits (1 month), then final slating for publication after article is type set, all figures are sized, article laid out and final version (1-2 months).
So all in the FDA takes less time (3-12 months) than publishing (12-17 months).
Related question: When I looked into LASIK/SMILE recently, they said that after onset of presbyopia, they now routinely recommend "monovision", that is, regulate one of your eyes to 0 diopters, but the other to mild myopia of about -1 diopter. Then you look at far things with the former, and near things with the latter. Good old stereo vision is somewhat impacted, but not too badly apparently.
Anyone got experience/comments on that? (Presumably one could replicate it with contact lenses, in particular.)
I was born with -4, +2 left and right eyes respectively (inherited), and as I get older towards reading glasses age, we have indeed found I get better corrective results from lenses when we tilt my right eye slightly better at distance and let my left eye pick up slightly more of reading.
My depth cohesion barely functions to begin with as a result of one eye being a legally-blind blur past three feet until I was 18, but I can confirm that once you have depth perception, it isn’t going to fail you just for a slight shift in focal efforts.
Look up Evo ICL [1]. It’s an implanted lens using the same procedure as cataract surgery.
Its major advantage over LASIK is reversibility. (Also lower incidence of dry eyes, a shorter healing time, no reduced night vision and UV protection for your retina if you’re outdoors a lot.) The major downside is it’s a bit more expensive.
I've had monovision after LASIK for about 5 years now. The brain adjusts in a few weeks and you cease to notice it. It rises to my awareness when I close one eye. Occasionally I'll notice it when trying to focus on something outside the center of my field of view but generally, no. It's an effective way to preserve near and far vision simultaneously.
That said, I've heard a fair number of people hate it and I get that.
My father had his eyes fixed like this about a decade ago and purports to be happy with it.
IIRC they did actually require that he wear contact lenses that replicated the effect for some amount of time (a month or so I believe) because there are people who are not happy with the arrangement. So they sort of force you to try before you buy.
I guess you could simulate the effect but getting a 1 diopter pair of reading glasses and knocking one of the lenses out. I have a stack of £1 reading glasses - I'll see if have have a pair that has independently modified itself thus.
Actually you can simulate it just by holding the current pair to one side. Kind of works but is a bit annoying compared to normal reading glass useage.
I was doing that for a few decades. Had to wear contacts for my astigmatism. Had my right dominant eye optimized for long distance, and the left with +1 or so for reading. I started to use cheap reading glasses on top when reading a lot. Had to give up the monovision trick and get multifocal glasses when my eyes aged more. But even with them, I kept a bit of monovision since I was so used to it.
This has been recommended to older people for a good while now (like, 60+). The biggest reason to avoid it would be if you need stereo vision for sports or hobbies. You lose some precision on your depth perception, so e.g. catching a ball might get harder. Doing intricate detail work might get harder.
My parents tried this with contacts and hated it, then tried again a year or so later and adjusted quickly and liked it (no clue why the first attempt was unsuccessful). They still use contacts (not interested in LASIK, I’m not sure why or if they have considered it) that do this and seem happy with it.
I've been doing this my whole life (about 20 years now) with contacts. I started in high school for fun after noticing that my contacts made it harder to see super-fine details at very short distances. I read an article about how some motivated people wore custom glasses which inverted the world upside-down, but their brains eventually compensated and flipped the image they perceived. I started wearing just one contact (alternating right, both, or left eye) and despite a diopter of -3.5 my brain learned to use the blurry color of my uncorrected eye to provide an acceptable level of depth perception while only giving me the sight picture from the corrected eye.
Thanks to an ophthalmologist with flexible practices, I'd later also managed to get some variety in my contacts - a bit higher power for sailing, where extreme long distance sight is helpful.
For activities which require precise stereo vision and/or maximum fine detail (soldering, foosball, skiing, sailing, etc) I prefer two contacts (or none, in the case of soldering). For general daily life I still enjoy one contact - my brain will use the picture from the uncorrected eye for close-up stuff, including computing, and the corrected picture for farther things, like driving. It's not perfect; I have to turn my head a lot more in one direction to check for traffic/etc and sometimes objects in the foreground create a large block of blurry vision.
But it's quite nice for daily life where I constantly switch from activities which are close (computers/reading) to far (everything else).
Like 'heikkilevanto, I may have to go back to stereo vision soon - my eyes are reaching the age where they're not as quick to focus and I don't see as much detail. Close-up work is getting much more difficult with just one eye. I can no longer solder at all with mono-vision, depth perception now only works for longer distances and not shorter ones. And far-vision is losing detail, so having two contacts makes it much easier to ascertain what I'm seeing faster because the detail from one eye fills in blurry spots of the other.
Some people have said that correcting vision prevents the eye from adapting and fixing itself to see better again. I haven't found this to be true. Contacts stay in my right eye better and tend to fall out of my left eye more frequently, so for the past decade I've almost always corrected in that eye and uncorrected in my left. My prescription for both eyes has not changed at all in the past decade - for me there seems to be no long-term change, good or bad, caused by correcting my vision.
I also wear contacts that you can keep in 24 hrs/day for 2-4 weeks, and have not seen any damage over the past 15 years of sleeping in my contacts for up to a month straight. I have annual "digital retinal exams" going back 15 years which can see the types of damage that are caused by sleeping in contacts too much (capillary growth due to lower oxygen, calcium deposits, etc) and there doesn't seem to be anything to note, as well as no significant difference between my right and left eye.
My experience with naturally-separated eyes matches this story: I can do approximate depth using the out of focus blurs, and I in fact just had my right eye correction tweaked slightly more long-distance vision out of personal preference. Refreshing to hear of someone else enjoying life in that style through voluntary means!
You can order one-eye reading glasses without a prescription online for use on top of contacts, fwiw - might give you a way to correct for closeup work, so long as you have a matched pair of L/0 and 0/R.
Indeed. You could make it brighter, which would shrink your pupils and make things easier to read. With this revolutionary medicine, you shrink your pupils, and then you need to make it brighter so you can still read. Is that it?
Ah that's interesting then. My guess would be that it doesn't close the iris as much then. However the linked does show 16% reporting dim vision, so there's some further work needed there (pupil size varies across the population, and there's the usual variation in dose efficacy.)
The other downside is that generally people read by recognizing word shapes, and at least for me the necessary pinhole is too small to see bigger chunks of text at once.
That's because bright light makes your pupil smaller, just like this medication.
It's plausible that making things sharper at the expense of making them appear dimmer would be a good trade for some people sometimes. And you don't have voluntary control over your pupil so this medication could help. But it seems like it would have very limited applicability.
This drug is for presbyopia (near things blurry) not myopia (far things blurry) but as these threads tend to discuss both, I will share something I read on HN many years ago that reversed my myopia: near-far focusing while outdoors. Just focus on something at >50 foot distance, focus on your finger right in front of your eye, near, far, near, far focusing just a few times. This completely reversed my early-stage myopia and my eyesight has been 20/20 for years since.
Yep, just back and forth, make sure your eyes fully focus before switching. What I do is roughly 2 sec near, 2 sec far, etc, whole thing takes me maybe 30 seconds, but some people say to do it much more or wait as long as 10 sec before switching. Make sure to do it outside in the sunlight. Oh, and if you notice one eye focuses better than the other, then try it with just the bad eye.
There's all sorts of discussion online and it's a pretty heated topic, flamewars, paid courses, forums, some people say it can only prevent it, some say it can reverse it, some say it does nothing, some will ban you for talking about it, etc. Then there is the even more controversial theory that you can recover from serious myopia with the "reduced lens" method. The popular opinion is that that's impossible, but there are a good handful of datapoints to the contrary. Personally, my myopia was never that bad, so I never got too deep into that stuff and just did the basic near-far-near exercises outside in the sun and that was enough to reverse the small decline in my vision.
It makes a little sense, but I'm not sure it's good for your eyes.
My eye doctor had me come in first thing in the morning, then again the next day at the end of the day, after my workday, and my vision had degraded about -0.25 to -0.5 over the course of the day, which is apparently pretty typical. If your prescription is just a little bit off, your eye muscles will work a little harder to hold things in focus, but over the course of the day, they get strained and tired, and at the end of the day they can't do it anymore.
I can imagine if you really strength-trained those muscles, you could hold things in focus for longer, more comfortably, and inversely, I could imagine if you never really worked those muscles they'd atrophy somewhat.
But I'm not sure really straining those muscles all-day-every-day is healthy long term. It would be like sitting on a wooden stool all day during your workday and saying "all you need to do is keep your core muscles strong by doing x/y/z workout a couple times a day," versus just getting a decent ergonomic chair.
Nothing wrong with a workout or keeping your muscles strong, but in order to last a full lifetime, your muscles need lots of rest too, and I imagine getting proper glasses definitely helps.
I appreciate the perspective, but near-far-near focusing in sunlight isn't some unusual type of workout. It is how my genus kept their eyes in shape for the last few million years and there is pretty comprehensive evidence that a lack thereof is the main cause of myopia's increasing prevalence. In light of that, I'll stick to what I'm doing.
> degraded about -0.25 to -0.5 over the course of the day
FWIW my ophthalmologist made the point that most people working on computers have eyes go too dry toward the end of the day, and that also causes blurry vision. Try some eye drops.
> But I'm not sure really straining those muscles all-day-every-day is healthy long term.
Consider it "normal use of the muscle" and not straining and how normally using your muscles is considered good for you.
Personally, I expect a good chunk of the effect to be on the brain side, not in the physical muscle. Like how parents sometimes tell kids with a lazy eye to "use both your eyes". Keep the brain from giving up on it.
It’s mentioned in the article, but there’s been a product on the market already for almost 5 years that does the same thing, with the same mechanism of action. That product, Vuity, has not been popular. The article makes it seem like the reason for Vuity’s lackluster performance is the incidence of side effects but I think it’s just not something people want to pay money for long term.
The article says that Vuity targeted the lens focusing muscles as well and that this product is the first that selectively acts on the pupil dilation muscles. That’s a big distinction.
How much will these cost? I'd love some immediately. I'm starting to need reading glasses and it is really disruptive to my whole life, I do lots of hobbies that need close up vision and never knew what life was like not having it.
Edit:
"During the investor call, Lenz executives outlined the cost of VIZZ. A monthly, 25-pack will cost $79. A 3-month pack from the e-pharmacy will cost $198 ($66 per month). Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025."
But the drops have the advantage of not messing with your distance vision like reading glasses do (unless you pay for varifocals, obvs.) - "[...] does not significantly affect the eye’s focusing muscles, so it doesn’t blur your distance vision [...]"
For someone who has to switch between near and distance often, I can see the drops being useful, especially if your distance vision is fine and you don't need varifocals.
If you're mid-40s (which is the threshold ago where I am), and can afford the up front cost, consider IOL implants. Life changing (for me). (and re: costs, these drops are going to set you back $1000 a year as well, so after 7/8 years implants would be 'cheaper').
I’d really like those. My Mom got them and she said it didn’t help her near vision, which I didn’t understand. I guess she was a weird case because yeah I had just assumed that a new lens would fix the hardening of the lens with aging problem. Thanks for letting me know!
How long should your new lenses last? Did they say? Will they eventually get hard like the human body’s lens or are you set for the rest of your life? It’s really cool you are part cyborg. Did you get a monofocal or multifocal lens?
Most artificial lenses, especially more than 5 years back, had a single focal point and did not adjust. You chose to either have near vision (mostly carless old people), far vision (and still use reading glasses), or blended vision (one eye far one near).
The flexible lens stuff is still relatively new and there are reports of them sort of being like 80% focused 100% of the time, which can suck. Apparently lots of individual variability in results, where as the single-focus lenses are 60s technology and well figured out.
I'd say there's a reason we've moved to daily contact lenses over re-usable ones, conveniently in a ~monthly~ 28-day pack!
There's obviously bound to be 'medical' and comfort reasons over disposable ones beyond the disposable society, but the cynic in me can't help but feel that research into longer-lasting more-comfortable reusable contacts would be taken through to market in preference to a more profitable cheaper-made daily product.
There's R&D pushing both ends to higher performance - dailies and monthlies. Dailies reduce chance of infection vs. putting in the same contact over and over 30 days in a row, and provide the highest quality vision every day because the contact degrades over 30 days of use.
Meanwhile on the monthly side of things, contacts that are approved for "extended wear" have enough oxygen permeability to be worn overnight now. Ten years ago, this was for up to 7-14 days (Biofinity), now they are up to 30 days (Air Optix Night & Day). This also greatly reduces the chance of infection (because you're not handling the contact 60 times per month) and is just super convenient because it's nice only having to touch your eye 12 times per year - you largely forget you're even shortsighted at all because you can see clearly from the moment you wake up till the moment you fall asleep every single day.
If anything, I'd argue that the monthly ones are the "scam" pricing, not the daily ones. They're priced just about the same per year, but the manufacturing costs must be significantly lower when you're only consuming 1/30th the number of units.
Regardless, the market appears to support ongoing R&D for both strategies.
> Permanent lenses had also led to some blood vessel overgrowth due to lack of oxygenation.
FWIW, this no longer appears to be the case. New "extended-wear" contacts have excellent oxygen permeability, and my ophthalmologist hasn't noticed any overgrowth of capillaries/vessels over the past 15 years of me wearing them. You can also sleep in them now, and I find them more comfortable than dailies actually, due to their high permeability.
Yep. Bright light does the same thing. Also, in dim light, I'd expect this to make it pretty hard to see. My optometrist mentioned it to me, but neither of us could see the point.
Hm, sometimes I pinch thumb and forefinger together and then bring the opposing forefinger in to join them, forming a triangular aperture. Takes two hands, but I guess I like the level of control. :p
"Gentle" or not, is this actually safe for long-term use? Your pupil dilates in indoor light for a reason, I'm not sure if it's a good idea to fight that. You'd be better off just increasing ambient light levels to match sunlight.
Oh it's worse than that just pupil shrinking in dark. Basically, cone cells see color and detail but need more light, rods see in low light but mostly serve peripheral vision. So your vision system is just wholly optimized to only doing detail work in fairly bright light; nighttime is for predator evasion.
Another way to look at that: We likely evolved decent color vision to identify edible fruits. That wasn't doable with vision in the dark (and we opted out of the olfactory tech tree), so now your accurate-vision tasks are optimized for daylight.
I can’t imagine it being unsafe (assuming the drug itself doesn’t do damage) since the restriction would let less light in. It’s not like forcibly dilating the pupil which could let in more light than the eye could handle. It could make things appear too dark while it’s happening though.
If it works by constricting the pupil I guess it's more like it's expanding the "depth of field". So you can't "over-correct" except in the sense that you will eventually run out of light.
I don't really understand eyes or optics though, I'm just guessing based on my layman's understanding of focussing a camera, so take this with a pinch of salt!
The drops work by selectively acting on the muscles that control pupil size, constricting the eyes’ aperture. As anyone who knows photography is aware, this increases the depth of field (a larger range of distances from the eye will be approximately in focus). Of course this also reduces the brightness on the retina, so things will be darker, an effect confirmed by the linked FDA data. In that data it’s claimed that the perceived dimness is “temporary”; I guess because of accommodation that kicks in after a while. So this is like increasing your f-stop and your ISO.
Mainly it is the people who left and were fired. The brightest would jump ship instantly when DOGE started firing, and these scientists had lots of places to go. And the people fired probably had a lot of expertise. I have seen similar happen many times in computer science over the last 40+ years in the business. Once a company starts firing, the smartest people jumps ship.
But yes, I cannot trust the FDA anymore because the people still there will be too scared to push real science. They may taint their results even without doing it on purpose due to that fear.
The same is starting to happen in medial research, but seems that is getting more press. Trump/Kennedy just handed all the US future medical advancement directly to China, and I am sure more will come. Where do you think these bio researchers will go ? China will hire them and maybe even set up a shell corp. for them in the US so they do not have to relocate. Just the knowledge and patents will be sent to China.
> The FDA approval comes based on trial data submitted by the pharmaceutical company, so it's worth noting that published peer-reviewed reports are yet to be published. Peer-reviewed publications often follow regulatory approvals, not precede them, which is common in the field of ophthalmology and dermatology.
Does anyone know the reason that data is published after approval rather than before? Seems illogical at face value, but I'm obviously missing something.
Short answer: FDA is totally toothless these days after decades of industry lobbying and Republican budget cuts. The industry has decided how they want things to work.
And you're thinking this ability to bypass scrutiny must lead to problems.
Correct. When liabilities grow too big, the company will spin off the liabilities to a shell company without means to pay for damages caused. (this is called a "Texas two-step" bankruptcy)
> And you're thinking this ability to bypass scrutiny must lead to problems.
Of course not. Side effects ? Which side effects ? /s
Please spend 30 seconds to search whether the fda budget has actually been cut over time (hint: it hasn’t)
The fda budget much like every other agency has grown incredibly in the last 50 years ( <1bnin 1992 to >6bn today). You can look at more recent numbers and see it’s still rising. When you hear cuts I’m spending it’s often cuts in proposed increases in spending which are often double digits. So you can grow an agency 10% a year for decades and then a single slow down or reversion to levels from just a year or two ago is seen as drastic cuts that will result in poison into our water.
https://www.google.com/search?hl=en&q=fda%20budget
You're not wrong about funding, but OP is correct about industry influence.
It varies a little by division/subject matter, but they basically have to run everything by industry and are subject to FOIAs and public shaming by senators and representatives beholden to industry.
Source: long-term partner of FDA employee, though this stuff is pretty widely understood.
> and are subject to FOIAs
How is that relevant?
>Short answer: FDA is totally toothless these days after decades of industry lobbying and Republican budget cuts.
The funny thing about short answers is that they're often partly or wholly full of shit and don't describe the underlying reality. For example, see how different things get when you look at actual information instead of pulling ideological talking points out of your ass without knowing what the hell is even the case? (A common thing on this site among so many self-described highly intelligent people)
This is the FDA's actual funding history over the last 3 decades (page 6 of the PDF), showing a steadily increasing budget across both Republican and Democrat admins. Curiously, some of its bigger budget increases coincided with the first Trump administration even. https://sgp.fas.org/crs/misc/R44576.pdf
You can educate yourself on the FDA process, including public access to all the FDA documentation, including meeting minutes and sponsorship slides. It’s all there on fda.gov
But instead of doing that you’ve decided to just write this comment instead and post something that looks quite silly for those that have taken the first approach.
When you navigate to the Clinical Trials section[1], the "View Clinical Trials Guidance Document" link[2] currently stalls, and then gives a 403 error page that says "Page Not Found". All of the information is not there on fda.gov, and whoever's in charge is doing a very sloppy job.
[1]https://www.fda.gov/science-research/science-and-research-sp...
[2]https://www.fda.gov/node/358362
Do you have any insights?
The claim that “the industry has decided how they want things to work” is laughable.
The numerous “not approved” decisions makes that plainly obvious. Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.
To the question at hand “why do publications come after FDA approval”, the FDA has access to all the data (actually more) before publication, so the publication is irrelevant to approval.
> Not to mention all the times FDA has said “you have to do X to get approved” and the company happily complies despite it delaying sales by several quarters.
The company happily complies?
Or just does it begrudgingly because not doing it delays sales a few more quarters if not indefinitely?
I'm not sure where you're getting the idea from that a company would happily do anything additional. It's a cost of doing business. Let's not pretend they're angels, they're in it for the money not the greater good.
And if that last statement needs a rationale, tell me who is doing the work to find the next antibiotic or any other non chronic disease medication
I'm pretty sure any certain path to approval makes the company happy. Ecstatic, even. They get to move the drug from the liabilities to the asset column of their ledger.
Do you feel that the happiness of the company is salient to GP's arguments? That is, by refuting that part, do you refute the entire?
I took issue with the happy part because it's a regulator not a customer kindly asking for a change.
Even if the cost of the change are very high, getting it approved is probably worthwhile. To say that they would do so happily implies that there's a motive beyond getting approval.
Based on these comments, maybe my interpretation was just off
> after decades of industry lobbying and Republican budget cuts
If only the Democrats had been in power in that period. And if only lobbying weren't something that was impossible to prevent by a neutral third party paid for by taxes to do exactly that.
It’s because the publishing process takes more time than the FDA review process.
Once the pivotal trial reads out, companies usually submit within a month or two to the FDA. Much of the submission dossier (trial design, product description) can be written ahead of time, so it’s really the results that need to be drafted.
The FDA can approve in as little as 3-4 months for an accelerated approval, but it can take up to 12 months.
Compare that with a paper being written and reviewed across multiple authors (3-6 months if you’re lucky), then submitting to multiple journals for review and feedback (6 months), then final submission and peer review (1-2 months), then any additional edits (1 month), then final slating for publication after article is type set, all figures are sized, article laid out and final version (1-2 months).
So all in the FDA takes less time (3-12 months) than publishing (12-17 months).
You aren’t allowed to sell / distribute / market to “peers” until fda approval.
probably influence on stock market and stuff.
Related question: When I looked into LASIK/SMILE recently, they said that after onset of presbyopia, they now routinely recommend "monovision", that is, regulate one of your eyes to 0 diopters, but the other to mild myopia of about -1 diopter. Then you look at far things with the former, and near things with the latter. Good old stereo vision is somewhat impacted, but not too badly apparently.
Anyone got experience/comments on that? (Presumably one could replicate it with contact lenses, in particular.)
I was born with -4, +2 left and right eyes respectively (inherited), and as I get older towards reading glasses age, we have indeed found I get better corrective results from lenses when we tilt my right eye slightly better at distance and let my left eye pick up slightly more of reading.
My depth cohesion barely functions to begin with as a result of one eye being a legally-blind blur past three feet until I was 18, but I can confirm that once you have depth perception, it isn’t going to fail you just for a slight shift in focal efforts.
Look up Evo ICL [1]. It’s an implanted lens using the same procedure as cataract surgery.
Its major advantage over LASIK is reversibility. (Also lower incidence of dry eyes, a shorter healing time, no reduced night vision and UV protection for your retina if you’re outdoors a lot.) The major downside is it’s a bit more expensive.
[1] https://us.discovericl.com/
From what I can tell, the regular ICL does not treat presbyopia, but a new version called Viva does. [1]
[1] https://www.presbyopiaphysician.com/issues/2023/december/evo...
I've had monovision after LASIK for about 5 years now. The brain adjusts in a few weeks and you cease to notice it. It rises to my awareness when I close one eye. Occasionally I'll notice it when trying to focus on something outside the center of my field of view but generally, no. It's an effective way to preserve near and far vision simultaneously.
That said, I've heard a fair number of people hate it and I get that.
My father had his eyes fixed like this about a decade ago and purports to be happy with it.
IIRC they did actually require that he wear contact lenses that replicated the effect for some amount of time (a month or so I believe) because there are people who are not happy with the arrangement. So they sort of force you to try before you buy.
I guess you could simulate the effect but getting a 1 diopter pair of reading glasses and knocking one of the lenses out. I have a stack of £1 reading glasses - I'll see if have have a pair that has independently modified itself thus.
Actually you can simulate it just by holding the current pair to one side. Kind of works but is a bit annoying compared to normal reading glass useage.
A family member used this strategy with contacts many years (30?) ago and they said it worked great.
I was doing that for a few decades. Had to wear contacts for my astigmatism. Had my right dominant eye optimized for long distance, and the left with +1 or so for reading. I started to use cheap reading glasses on top when reading a lot. Had to give up the monovision trick and get multifocal glasses when my eyes aged more. But even with them, I kept a bit of monovision since I was so used to it.
This has been recommended to older people for a good while now (like, 60+). The biggest reason to avoid it would be if you need stereo vision for sports or hobbies. You lose some precision on your depth perception, so e.g. catching a ball might get harder. Doing intricate detail work might get harder.
My parents tried this with contacts and hated it, then tried again a year or so later and adjusted quickly and liked it (no clue why the first attempt was unsuccessful). They still use contacts (not interested in LASIK, I’m not sure why or if they have considered it) that do this and seem happy with it.
I've been doing this my whole life (about 20 years now) with contacts. I started in high school for fun after noticing that my contacts made it harder to see super-fine details at very short distances. I read an article about how some motivated people wore custom glasses which inverted the world upside-down, but their brains eventually compensated and flipped the image they perceived. I started wearing just one contact (alternating right, both, or left eye) and despite a diopter of -3.5 my brain learned to use the blurry color of my uncorrected eye to provide an acceptable level of depth perception while only giving me the sight picture from the corrected eye.
Thanks to an ophthalmologist with flexible practices, I'd later also managed to get some variety in my contacts - a bit higher power for sailing, where extreme long distance sight is helpful.
For activities which require precise stereo vision and/or maximum fine detail (soldering, foosball, skiing, sailing, etc) I prefer two contacts (or none, in the case of soldering). For general daily life I still enjoy one contact - my brain will use the picture from the uncorrected eye for close-up stuff, including computing, and the corrected picture for farther things, like driving. It's not perfect; I have to turn my head a lot more in one direction to check for traffic/etc and sometimes objects in the foreground create a large block of blurry vision.
But it's quite nice for daily life where I constantly switch from activities which are close (computers/reading) to far (everything else).
Like 'heikkilevanto, I may have to go back to stereo vision soon - my eyes are reaching the age where they're not as quick to focus and I don't see as much detail. Close-up work is getting much more difficult with just one eye. I can no longer solder at all with mono-vision, depth perception now only works for longer distances and not shorter ones. And far-vision is losing detail, so having two contacts makes it much easier to ascertain what I'm seeing faster because the detail from one eye fills in blurry spots of the other.
Some people have said that correcting vision prevents the eye from adapting and fixing itself to see better again. I haven't found this to be true. Contacts stay in my right eye better and tend to fall out of my left eye more frequently, so for the past decade I've almost always corrected in that eye and uncorrected in my left. My prescription for both eyes has not changed at all in the past decade - for me there seems to be no long-term change, good or bad, caused by correcting my vision.
I also wear contacts that you can keep in 24 hrs/day for 2-4 weeks, and have not seen any damage over the past 15 years of sleeping in my contacts for up to a month straight. I have annual "digital retinal exams" going back 15 years which can see the types of damage that are caused by sleeping in contacts too much (capillary growth due to lower oxygen, calcium deposits, etc) and there doesn't seem to be anything to note, as well as no significant difference between my right and left eye.
My experience with naturally-separated eyes matches this story: I can do approximate depth using the out of focus blurs, and I in fact just had my right eye correction tweaked slightly more long-distance vision out of personal preference. Refreshing to hear of someone else enjoying life in that style through voluntary means!
You can order one-eye reading glasses without a prescription online for use on top of contacts, fwiw - might give you a way to correct for closeup work, so long as you have a matched pair of L/0 and 0/R.
That sounds absolutely awful.
All it does is make the pupil smaller? Sure that will improve sharpness, but less light will reach the retina.
Indeed. You could make it brighter, which would shrink your pupils and make things easier to read. With this revolutionary medicine, you shrink your pupils, and then you need to make it brighter so you can still read. Is that it?
I can see the marketing now: "Bottled Squintz®", when normal squinting is too much strain or annoyance.
When in a pinch, one can make a tiny pinhole with their fingers for a similar effect.
It comes with the same downside: reading in low light is difficult.
For pinhole intraocular lenses these are implanted in just one eye for the same reason.
I imagine this product would be used in just one eye at a time.
> I imagine this product would be used in just one eye at a time
The dosage instructions say to use it in both eyes
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/21...
Ah that's interesting then. My guess would be that it doesn't close the iris as much then. However the linked does show 16% reporting dim vision, so there's some further work needed there (pupil size varies across the population, and there's the usual variation in dose efficacy.)
The other downside is that generally people read by recognizing word shapes, and at least for me the necessary pinhole is too small to see bigger chunks of text at once.
That combined with: my presbyopia bothers me most when it's already dark. Bright light makes small text easier to read.
That's because bright light makes your pupil smaller, just like this medication.
It's plausible that making things sharper at the expense of making them appear dimmer would be a good trade for some people sometimes. And you don't have voluntary control over your pupil so this medication could help. But it seems like it would have very limited applicability.
This drug is for presbyopia (near things blurry) not myopia (far things blurry) but as these threads tend to discuss both, I will share something I read on HN many years ago that reversed my myopia: near-far focusing while outdoors. Just focus on something at >50 foot distance, focus on your finger right in front of your eye, near, far, near, far focusing just a few times. This completely reversed my early-stage myopia and my eyesight has been 20/20 for years since.
I (and others) make this comment on HN from time to time: https://news.ycombinator.com/item?id=38794682 - hopefully it helps others.
Just quickly back and forth? For how long in total? Would love to try this
Yep, just back and forth, make sure your eyes fully focus before switching. What I do is roughly 2 sec near, 2 sec far, etc, whole thing takes me maybe 30 seconds, but some people say to do it much more or wait as long as 10 sec before switching. Make sure to do it outside in the sunlight. Oh, and if you notice one eye focuses better than the other, then try it with just the bad eye.
There's all sorts of discussion online and it's a pretty heated topic, flamewars, paid courses, forums, some people say it can only prevent it, some say it can reverse it, some say it does nothing, some will ban you for talking about it, etc. Then there is the even more controversial theory that you can recover from serious myopia with the "reduced lens" method. The popular opinion is that that's impossible, but there are a good handful of datapoints to the contrary. Personally, my myopia was never that bad, so I never got too deep into that stuff and just did the basic near-far-near exercises outside in the sun and that was enough to reverse the small decline in my vision.
It makes a little sense, but I'm not sure it's good for your eyes.
My eye doctor had me come in first thing in the morning, then again the next day at the end of the day, after my workday, and my vision had degraded about -0.25 to -0.5 over the course of the day, which is apparently pretty typical. If your prescription is just a little bit off, your eye muscles will work a little harder to hold things in focus, but over the course of the day, they get strained and tired, and at the end of the day they can't do it anymore.
I can imagine if you really strength-trained those muscles, you could hold things in focus for longer, more comfortably, and inversely, I could imagine if you never really worked those muscles they'd atrophy somewhat.
But I'm not sure really straining those muscles all-day-every-day is healthy long term. It would be like sitting on a wooden stool all day during your workday and saying "all you need to do is keep your core muscles strong by doing x/y/z workout a couple times a day," versus just getting a decent ergonomic chair.
Nothing wrong with a workout or keeping your muscles strong, but in order to last a full lifetime, your muscles need lots of rest too, and I imagine getting proper glasses definitely helps.
I appreciate the perspective, but near-far-near focusing in sunlight isn't some unusual type of workout. It is how my genus kept their eyes in shape for the last few million years and there is pretty comprehensive evidence that a lack thereof is the main cause of myopia's increasing prevalence. In light of that, I'll stick to what I'm doing.
> degraded about -0.25 to -0.5 over the course of the day
FWIW my ophthalmologist made the point that most people working on computers have eyes go too dry toward the end of the day, and that also causes blurry vision. Try some eye drops.
> But I'm not sure really straining those muscles all-day-every-day is healthy long term.
Consider it "normal use of the muscle" and not straining and how normally using your muscles is considered good for you.
Personally, I expect a good chunk of the effect to be on the brain side, not in the physical muscle. Like how parents sometimes tell kids with a lazy eye to "use both your eyes". Keep the brain from giving up on it.
It’s mentioned in the article, but there’s been a product on the market already for almost 5 years that does the same thing, with the same mechanism of action. That product, Vuity, has not been popular. The article makes it seem like the reason for Vuity’s lackluster performance is the incidence of side effects but I think it’s just not something people want to pay money for long term.
The article says that Vuity targeted the lens focusing muscles as well and that this product is the first that selectively acts on the pupil dilation muscles. That’s a big distinction.
How much will these cost? I'd love some immediately. I'm starting to need reading glasses and it is really disruptive to my whole life, I do lots of hobbies that need close up vision and never knew what life was like not having it.
Edit:
"During the investor call, Lenz executives outlined the cost of VIZZ. A monthly, 25-pack will cost $79. A 3-month pack from the e-pharmacy will cost $198 ($66 per month). Samples are anticipated in the United States as early as October 2025, with commercial product to be broadly available by mid-Q4 2025."
Versus $15 reading glasses that will last years if you are just slightly careful with them. Hmmm
> Versus $15 reading glasses that will last years
But the drops have the advantage of not messing with your distance vision like reading glasses do (unless you pay for varifocals, obvs.) - "[...] does not significantly affect the eye’s focusing muscles, so it doesn’t blur your distance vision [...]"
For someone who has to switch between near and distance often, I can see the drops being useful, especially if your distance vision is fine and you don't need varifocals.
If you're mid-40s (which is the threshold ago where I am), and can afford the up front cost, consider IOL implants. Life changing (for me). (and re: costs, these drops are going to set you back $1000 a year as well, so after 7/8 years implants would be 'cheaper').
I’d really like those. My Mom got them and she said it didn’t help her near vision, which I didn’t understand. I guess she was a weird case because yeah I had just assumed that a new lens would fix the hardening of the lens with aging problem. Thanks for letting me know!
How long should your new lenses last? Did they say? Will they eventually get hard like the human body’s lens or are you set for the rest of your life? It’s really cool you are part cyborg. Did you get a monofocal or multifocal lens?
Most artificial lenses, especially more than 5 years back, had a single focal point and did not adjust. You chose to either have near vision (mostly carless old people), far vision (and still use reading glasses), or blended vision (one eye far one near).
The flexible lens stuff is still relatively new and there are reports of them sort of being like 80% focused 100% of the time, which can suck. Apparently lots of individual variability in results, where as the single-focus lenses are 60s technology and well figured out.
priced just below higher end daily contacts. tempting. but i need more than 10 hours usually
Interesting. Now I'm worried we're moving from prescription lenses to subscription lenses.
I'd say there's a reason we've moved to daily contact lenses over re-usable ones, conveniently in a ~monthly~ 28-day pack!
There's obviously bound to be 'medical' and comfort reasons over disposable ones beyond the disposable society, but the cynic in me can't help but feel that research into longer-lasting more-comfortable reusable contacts would be taken through to market in preference to a more profitable cheaper-made daily product.
Daily contact lenses have several advantages. They:
- don't accumulate gunk over days/weeks/months that can cause injury and/or infection
- are cheap to replace if torn or lost (which happens with tiny transparent things)
- are made from softer, thinner material (because it doesn't need to last) which is way more comfortable
There's R&D pushing both ends to higher performance - dailies and monthlies. Dailies reduce chance of infection vs. putting in the same contact over and over 30 days in a row, and provide the highest quality vision every day because the contact degrades over 30 days of use.
Meanwhile on the monthly side of things, contacts that are approved for "extended wear" have enough oxygen permeability to be worn overnight now. Ten years ago, this was for up to 7-14 days (Biofinity), now they are up to 30 days (Air Optix Night & Day). This also greatly reduces the chance of infection (because you're not handling the contact 60 times per month) and is just super convenient because it's nice only having to touch your eye 12 times per year - you largely forget you're even shortsighted at all because you can see clearly from the moment you wake up till the moment you fall asleep every single day.
If anything, I'd argue that the monthly ones are the "scam" pricing, not the daily ones. They're priced just about the same per year, but the manufacturing costs must be significantly lower when you're only consuming 1/30th the number of units.
Regardless, the market appears to support ongoing R&D for both strategies.
Dailies were a vast improvement in comfort and convenience for me over permanent lenses that required cleaning and storing overnight.
Permanent lenses had also led to some blood vessel overgrowth due to lack of oxygenation.
Using a new pair everyday does make quite a few tricky problems go away downside being slight extra cost and extra plastic pollution.
> Permanent lenses had also led to some blood vessel overgrowth due to lack of oxygenation.
FWIW, this no longer appears to be the case. New "extended-wear" contacts have excellent oxygen permeability, and my ophthalmologist hasn't noticed any overgrowth of capillaries/vessels over the past 15 years of me wearing them. You can also sleep in them now, and I find them more comfortable than dailies actually, due to their high permeability.
This is really individual. I tried Air Optix, and I kept waking up with my eyes glued shut from mucus.
My monthly lenses work great, and the only way I can tell that they’re in is the fact that distant objects are clear.
Just when I was finally coming to grips with needing bifocals.
“VIZZ works by gently shrinking the pupil of the eye”
Does this mean you could replicate the effect with brighter lighting? I was hoping for something that would actually make the lens more flexible.
Yep. Bright light does the same thing. Also, in dim light, I'd expect this to make it pretty hard to see. My optometrist mentioned it to me, but neither of us could see the point.
> but neither of us could see the point
... maybe you should be using it then? (Sorry... but not sorry.)
[dead]
You can focus things by looking through a pinhole formed by curling your pointer finger and thumb.
Hm, sometimes I pinch thumb and forefinger together and then bring the opposing forefinger in to join them, forming a triangular aperture. Takes two hands, but I guess I like the level of control. :p
or squinting
That deforms the eye a bit, and the aperture is too wide. Doesn't work nearly as well as a pinhole made by other means.
I suspect the "aperture" is actually holes made with your eyelids top and bottom with your eyelashes on the sides.
>gently shrinking
"Gentle" or not, is this actually safe for long-term use? Your pupil dilates in indoor light for a reason, I'm not sure if it's a good idea to fight that. You'd be better off just increasing ambient light levels to match sunlight.
Wait, is this why when I'm having trouble seeing something small, it becomes easier when I get way more light on it?
I just assumed more photons results in a stronger signal to my rods and cones. But maybe it's making my eye shrink the aperture instead (or both).
Oh it's worse than that just pupil shrinking in dark. Basically, cone cells see color and detail but need more light, rods see in low light but mostly serve peripheral vision. So your vision system is just wholly optimized to only doing detail work in fairly bright light; nighttime is for predator evasion.
Another way to look at that: We likely evolved decent color vision to identify edible fruits. That wasn't doable with vision in the dark (and we opted out of the olfactory tech tree), so now your accurate-vision tasks are optimized for daylight.
I can’t imagine it being unsafe (assuming the drug itself doesn’t do damage) since the restriction would let less light in. It’s not like forcibly dilating the pupil which could let in more light than the eye could handle. It could make things appear too dark while it’s happening though.
This is probably why I need to have my phone at 100% brightness to read it.
It's not clear if this will be a prescription product or over the counter. Anyone know?
So, if someone only has mild presbyopia do they take less? What happens if you take 'too much' for your level of impairment?
If it works by constricting the pupil I guess it's more like it's expanding the "depth of field". So you can't "over-correct" except in the sense that you will eventually run out of light.
I don't really understand eyes or optics though, I'm just guessing based on my layman's understanding of focussing a camera, so take this with a pinch of salt!
You are correct.
Note that it shrinks the pupils which is cosmetically not great.
People might also think you're a junkie.
Drugs of the recreational kind cause pupil dilation. These drops cause contraction.
Opioids can cause contraction, but probably not what you were thinking of?
Yes I meant opioids.
Maybe it’s different in other places but over here a “junkie” specifically refers to a heroin or other opioid addict not a general drug user.
any info on availability in the EU?
The drops work by selectively acting on the muscles that control pupil size, constricting the eyes’ aperture. As anyone who knows photography is aware, this increases the depth of field (a larger range of distances from the eye will be approximately in focus). Of course this also reduces the brightness on the retina, so things will be darker, an effect confirmed by the linked FDA data. In that data it’s claimed that the perceived dimness is “temporary”; I guess because of accommodation that kicks in after a while. So this is like increasing your f-stop and your ISO.
I'll pass. Due to FDA cuts, I will wait years before I consider this product.
What cuts? I looked online and I don't see a single year that it's ever gone down
Let me do a web search for you. Many smart people where fired by DOGE and many left on their own due to Trump. So,I no longer trust the FDA.
https://www.yahoo.com/news/doge-reportedly-fired-fda-employe...
There are many articles about that.
i thought you meant budget cuts, of which there never has been as far as i can tell
there was a 20% headcount reduction, down to a very meager 15,000 people. you dont believe the FDA can properly function with 15,000 employees?
I can see where you were thinking of $, sorry.
Mainly it is the people who left and were fired. The brightest would jump ship instantly when DOGE started firing, and these scientists had lots of places to go. And the people fired probably had a lot of expertise. I have seen similar happen many times in computer science over the last 40+ years in the business. Once a company starts firing, the smartest people jumps ship.
But yes, I cannot trust the FDA anymore because the people still there will be too scared to push real science. They may taint their results even without doing it on purpose due to that fear.
The same is starting to happen in medial research, but seems that is getting more press. Trump/Kennedy just handed all the US future medical advancement directly to China, and I am sure more will come. Where do you think these bio researchers will go ? China will hire them and maybe even set up a shell corp. for them in the US so they do not have to relocate. Just the knowledge and patents will be sent to China.
https://www.comicsands.com/rfk-jr-mrna-contracts
So Trump and friends is destroying the US right in front of everyone here.
[flagged]
So Retinox5 from Star Trek?
But I'm allergic to Retinox.