Viatris gets FDA nod for pupil dilation reversal agent
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Re: Viatris gets FDA nod for pupil dilation reversal agent
#2There have been "reversal" drops for a while now, right? And with sufficiently dark sunglasses, driving is still not a problem.
Re: Viatris gets FDA nod for pupil dilation reversal agent
#3At 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.
Re: Viatris gets FDA nod for pupil dilation reversal agent
#4> 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?
Re: Viatris gets FDA nod for pupil dilation reversal agent
#5I'm guessing this is something specific to the US.
Re: Viatris gets FDA nod for pupil dilation reversal agent
#6There 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.
Re: Viatris gets FDA nod for pupil dilation reversal agent
#7At 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.
Re: Viatris gets FDA nod for pupil dilation reversal agent
#8At 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.
Re: Viatris gets FDA nod for pupil dilation reversal agent
#9I'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.
Re: Viatris gets FDA nod for pupil dilation reversal agent
#10> 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 comfort…
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.