Viatris gets FDA nod for pupil dilation reversal agent | Hacker News Reader

Viatris gets FDA nod for pupil dilation reversal agent

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27 pointsbookofjoe41 comments

At my most recent eye exam, I paid an extra $40 or so to have some kind of digital retinal imaging done (no dilation required) and the amount of detail the doctor could see was phenomenal to my eye (no pun intended).

They were perhaps making more money on it, but seemed to push it as medically superior to the dilation and manual inspection process.

I'm surprised, I thought the digital imaging was the standard now. The eye doctor I've been going to for several years now only does the new method and doesn't even offer dilation afaik.

Insurance doesn't cover it, so some doctors don't bother with it. I was caught by surprise when I tried out my wife's ophthalmologist. Dilation only, no option for a digital scan, my choices were get dilated or get out. I'm not going back there.

That's exactly consistent with what they said to me. "Insurance covers the dilation procedure; the digital imaging is better but you have to pay $X [$40 or $49, I forget] out of pocket." "Which one is medically better?" "Digital." "Let's do that one."

Even as they did the multiple exposures, I was wondering if I was getting suckered, but when the doctor showed me what she could see in the digital images and that she could use them to track any changes over the years, I felt really good about spending the money.

You compared that with what they could see with the prehistoric method?

Even if you can see pretty much the same thing, there's still the benefit of getting comparison images.

That cannot be understated. I've got something in one eye, which shows up on both digital scan and normal dilation. But the archives of the digital scans makes it possible to clearly see if it is changing over time.

Obviously, I don't have any idea what she could see using the old method. However, when she pulled up the image on the screen and walked me through what she was seeing, I could judge from her overall excitement in showing me the details and from what I was able to see, that she thought it was a great tool and I had no reason to doubt and some reasons to believe.

For me that 'tracking over the years' was secondary. Having had glasses for years the hours of not having to hide in the dark was a 'shut up take my money' moment.

Interesting, my insurance covered it last year. However it was related to eye trauma rather than a regular vision visit, so perhaps that's why.

My understanding is that would be covered under medical insurance?

Yes, acute care for eye injuries (or potential injuries like to verify the eye is fine after it was hit) is covered under health insurance (in the US) and not typically covered by vision insurance. Vision insurance mostly covers your routine exams, glasses, and contacts. If you have a real health issue (glaucoma, macular degeneration, etc.) with your eyes and not a vision issue (myopia, presbyopia) then that's also covered under your health insurance and not your vision insurance.

Here in AUS, essentially every single optometrist requires digital imaging. Oh, and it’s subsidised by the government.You don’t pay a single cent for a prescription. Bonus: If you have private optical health insurance it will likely cover two pairs of prescription glasses per year. Not too bad a deal if you ask me!

My local glasses shop had this as an option, but only at a location that was a bit out of my way. Would have loved to try it, though!

Optomap is the (commercial?) name for this. A previous Silicon Valley ophthalmologist I went to swore by it and I saw the value, given a family history of macular degeneration, but out here no one has the very expensive machine.

I don't even care if it makes them more profit than drops, I'm MUCH more likely to use the digital system rather than drops, so the value is there for me.

There have been "reversal" drops for a while now, right? And with sufficiently dark sunglasses, driving is still not a problem.

The driving bit seems to have been some editorializing on the submitter's part, the title has been changed to match the article.

>For instance, pharmacologically-induced mydriasis causes sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work and drive.

The article content mentions driving though.

Yeah, but the original submission title (not the title of the article nor clearly based on the article) implied that in the US people are not supposed to (as in by some medical rule) drive after having their eyes dilated. It was something like "Soon people in the US can drive after eye dilation". Considering plenty of people drive after eye dilation already and there is no rule barring it the title was weird and bordering on nonsensical editorializing.

You can drive with dilated pupils, but you may have a hard time reading signs or even reading your speedometer.

That's what the pinhole glasses are for.

Based on structure (but not the Ames test), phentolamine has some genotoxic metabolites. I wonder why they chose that alpha agonist and not a different one (of which there are many).

> In both pivotal studies, a statistically significantly greater percentage of subjects experienced their study eyes returning to normal at all time points measured from 60 minutes through 24 hours in the Ryzumvi group compared with placebo.

Thanks, FDA, industry standards, and general statistics education. This means almost nothing.

How much does it help? What fraction of people are helped? Can one still see comfortably in dim light after administration of dilating drops followed by this? Does it also reverse cycloplegia?

Here's the study results: https://clinicaltrials.gov/study/NCT05134974?tab=results

They mostly only studied pupil diameter - there is one visual acuity test measurement (at normal lighting conditions) performed at 6 hours that maybe shows improvement.

So the effect on dilation is pretty large. Why doesn’t the headline say that?

The accommodation results are indeed unimpressive.

Because the target audience of the headline isn’t patients, but investors.

Sure, but investors like a “significant improvement” because the FDA likes it, and IMO that is the problem.

So now someone can eat shrooms and not have dilated eyes?

I'm guessing this is something specific to the US.

Yes, the FDA is a US-only institution. Full name is: U.S. Food and Drug Administration.

I was commenting on the original title, I meant that being unable to drive due to the after affects of some unknown procedure is a US specific thing.

It is not, at least not since I've had my eyes dilated in exams (every year or every other for the past 25 years). OP was editorializing. There is no mandated minimum time between dilation and driving, though obviously people should be cautious if dilation strongly impacts their vision. For me, I'm usually back to "normal" (near vision still sucks, but I don't read books while driving; far vision is fine) by the time I've finished ordering new lenses and paying.

Why do you need your eyes dilated? It isn't something that is done in the UK.

My vision is very, very bad. Eye dilation is to allow the doctor to examine the retinas, in my case. Though as others have pointed out they're doing more digital imaging these days and that doesn't require dilation. My doctor now dilates my eyes every other year.

If your vision is normal (or not as abnormal as mine) and you aren't at high risk of various eye health issues (diabetic, family history, high blood pressure) then there's little need for dilation in an eye exam.

My eye checks every other year have had a retinal exam component for as long as I can remember, never been given any drugs to affect the pupil diameter though.

That was what they did for me until my eyes exceeded about -8 or -9 diopters of correction (late high school, not sure where it was exactly when they started dilating them but in that range), then they introduced dilation as a regular thing.

It's considered good practice to get regular eye exams for catching problems inside the eye, and the most common way of doing an eye exam is by shining a bright light inside the eye and viewing it with a magnifier. The illumination only works if pupils can't accommodate. NB in the USA nobody I know does get regular eye exams but we should especially later in life because some types of macular degeneration can be slowed down somewhat with various therapies

_raises hand_ Hello! I, and my extended family, have gotten yearly eye exams for at least as long as I've been alive.

Not sure what the original title was, but when I've had my eyes dilated for eye exams in the past, I have no problem driving home immediately.

It is commonplace for eye doctors to hand out these ugly sunglasses to patients who have their eyes dilated, so they can continue on with their day: https://www.proopticsgroup.com/cdn/shop/products/G100_New_20...

It's a pretty common procedure worldwide; an ophthalmologist dilates the patient's pupils with eyedrops to be able to look inside them with a bright light and inspect for problems. Then afterwords the patient is sensitive to light for a few hours which impacts driving and everything else. Sunglasses work but the people most likely to see an eye doctor are those with glasses, and corrective sunglasses are pretty rare. Some eye doctors give out dark tinted face shield type things. The pupil-dilating drug is an anticholinergic like belladonna which has been known about for thousands of years (cf. name "belladonna" from the plant's use to dilate pupils as a cosmetic for "pretty ladies")

(typically an anticholinergic like beladonna which has been known about for thousands of years)

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