Are there any clinical trials for dry AMD?

[eyedoc27]

I have a patient who, like others, is really hoping for anything to improve his vision. I told him I’d try and find out if there are any trials he can enroll in. Anyone know of anything?

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[MstaKing10]

Probably about a dozen or more. And there is a new FDA approved treatment Syfovre

https://investors.apellis.com/news-releases/news-release-details/fda-approves-syfovretm-pegcetacoplan-injection-first-and-only

 

[Dusn]

I think it depends on what’s the reason for the decreased vision? Is there foveal atrophy?

 

[eyedoc27]

Thank you. I have a patient with geographic atrophy, and a separate patient with CNVM with scarring (no CME). For the latter I tried 2 Avastin and no improvement in vision as expected. He wants to try anything possible. If anyone knows of trials and how to actually enroll please let me know.

 

[Dusn]

First cases of retinal vasculitis with vision loss being reported for Apellis/syfovre. All for a drug that reported no actual vision benefit in trials.

 

[MstaKing10]

First cases of retinal vasculitis with vision loss being reported for Apellis/syfovre. All for a drug that reported no actual vision benefit in trials.

How was this reported? I’ve heard about it but can’t verify

 

[Slide]

How was this reported? I’ve heard about it but can’t verify

I’ve heard similar from a reliable source as well. Suspect we will be hearing news soon once confirmed.

 

[Slide]

It's now official. 6 cases of retinal vasculitis per ASRS. If it's not addressed quick, Syfovre is going to be effectively kneecapped, even if the incidence is small.

 

[hello lady!]

It's now official. 6 cases of retinal vasculitis per ASRS. If it's not addressed quick, Syfovre is going to be effectively kneecapped, even if the incidence is small.

I haven't seen this report. Was it in email? I've tried searching and haven't been able to find it.

 

[MstaKing10]

It’s done. Beovus evil cousin.

 

[Dusn]

This is the problem with not having vision as the study’s primary endpoint. As far as I know, there was no vision improvement in the clinical trial after 2 years. Has anyone heard of any vision benefit from the clinical trials?

We can argue that patients with GA encroaching on the fovea might have a vision benefit. But If there was a vision benefit in any subpopulation, sub analysis, or ad hoc analysis, I’m sure the company would have announced that information to everyone. They may not want to report adverse events but I’ve never heard of a drug company not reporting any positive signals.

Now I’d have legitimate concern that the risks exceeds the benefits.

 

[docdoc2012]

The statistic for vasculitis that the official statements are showing (1/10,000) is based on number of vials distributed (6 cases out of 60k distributed vials), not administered. The percentage is actually likely much higher.

This is extremely disingenuous on their part. Not a good way to get docs on board with your product.

 

[MstaKing10]

Their email from Baumel also implicates doctors for not drawing up the med with sterile technique. That really rubbed me the wrong way.

I am hearing one or two of these cases may have been culture positive endo. Not sure how this will play out but for the time being I'm holding my injections even on established patients who have received their first or second dose. Definitely not starting any new patients.

 

[Slide]

I haven't seen this report. Was it in email? I've tried searching and haven't been able to find it.

In case you haven’t found it already

ASRS reports six cases of occlusive retinal vasculitis linked to pegcetacoplan injection

According to the ASRS Research and Safety in Therapeutics Committee, ophthalmologists noted instances of intraocular inflammation (IOI) after the initial injection of pegcetacoplan.

www.ophthalmologytimes.com

 

[Slide]

Their email from Baumel also implicates doctors for not drawing up the med with sterile technique. That really rubbed me the wrong way.

I am hearing one or two of these cases may have been culture positive endo. Not sure how this will play out but for the time being I'm holding my injections even on established patients who have received their first or second dose. Definitely not starting any new patients.

So they’re pulling a Regeneron on this? Yeah I’m sure that’s gonna go well with the retina community.