A few updates on prior topics…
Having had more time with some newer products and a recent update on further delays on an expected new product, I can provide some “new updates.” As of today, I have updated my posts on Xdemvy and Demodex treatments https://www.eyethera.com/blog/demodex-the-tiny-mite-with-a-big-effect-on-dry-eye-disease?rq=xdemvy My Lacrifill and punctal plugging treatments https://www.eyethera.com/blog/news-updates?rq=lacrifill and can say a few words about Reproxalap. My initial post on this novel, “steroid-like” anti-inflammatory (working upstream in a way that can have near immediate effectiveness without the apparent risk of elevated eye pressure or accelerating cataracts) is found here: https://www.eyethera.com/blog/are-there-any-new-eye-drops-for-dry-eye?rq=Reproxalap
Unfortunately the FDA did not find enough evidence of efficacy in the latest round of FDA-application-related studies: https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-receives-complete-response-letter-us-food-0 It is possible that it will pass muster later this year, as at least some of the FDA’s reservations were based on preliminary study results where more data should be available later this year. In an eye doctor publication “Ocular Surgery News,” Dr. White summed things up well (as he so often does) - and since I share his “fanboy” cheering for Repraxolap, I will post his comments here: “Sad tidings arrived in my inbox early this morning. Once again, reproxalap has come up short with its FDA filing for approval.
All the right people are saying all the right things as we read in CEO Todd Brady’s comments and as we are hearing from the halls of AbbVie: Aldeyra will carry on with the studies it launched in response to last fall’s FDA response, and AbbVie is still “all in.” According to Mr. Brady, a second field trial and another dry eye chamber study will report topline results in the upcoming second quarter.
So, what does it all mean? I have made no secret of my fanboy status for reproxalap. The mechanism of action — inhibiting the reactive aldehyde species that sit at the tippy top of the entire inflammatory cascade pyramid — makes a ton of sense to me. Regulating ocular surface inflammation with a single drop, as if you had your hand on a rheostat, is a highly attractive proposition. I have been not-so-silently cheering for this drug for several years.
Unfortunately, the choice of so-called “chamber” studies, heretofore untested as routes to FDA approval, has proven to be an obstacle. A field trial readout last fall met its endpoints.
Hopefully, both trials still open will do so as well. Will two positive field trials be enough? Will it matter how the dry eye chamber trial turns out if the field trial is positive? It is time for Aldeyra and AbbVie to start spreading glad tidings of a new and wonderful treatment option.
Fanboys and girls alike are out here with fingers and toes crossed.
Darrell E. White, MD
A friend and colleague - (as well as the inventor of the Zocuwipes and Zocugel products I find so helpful) - Peter Pham, MD, pointed out from a chemical perspective, reproxalap faces some basic chemistry issues. Highly simplifying and paraphrasing him, the natural environment of the surface of the eye is a chemical hotbed of activity with lots of chemical competition for this upstream inhibitor of inflammation to fight against. He notes: “This would help to explain why it took a second dose an hr or so after the first before any significant effects showed up.” My sense is that when working with a new, novel approach to a complex problem like dry eye disease, that there will likely be a good place for reproxalap in the future, but we have a bit more to learn about the best way to use it (and perhaps for which group of patients it will be most beneficial). Keep your fingers (& toes) crossed (like me).