Priority Review Status for Accelerated Corneal Cross-linking

posted Dec 2, 2013, 2:33 PM by Jen Weigel
At the end of November, the FDA notified Avedro that they will be given Priority Review Status for their New Drug Application (NDA) for their proprietary Riboflavin/Accelerated Corneal Cross-linking procedure.  This is great news for all the patients that we saw that need cross-linking but could not yet qualify for the study.  A lot of these patients in need had KCN, but they did not have enough drop in VA yet to qualify for the study.  The study guidelines make 100% complete logical sense, don't get me wrong.  You can't run a study on patients that are 20/20 BCVA, I get that.  But, when this whole system gets approval, I'd love to start saving and preserving vision on a greater number of KCN patients!

So, what is Priority Review Status?  Seems there is something called Prescription Drug User Fee Act (PDUFA) which allows companies to pay larger fees when they request their application to be reviewed.  When the company pays a larger fee, the FDA can provide more reviewers, and this accelerates the review process.  From what I can gather, they can do this for medications and procedures that have shown to be of good benefit to patients.  It's a way to get what is needed out there faster.  It can cut the FDA's review time from 10 long months to just 6 short months!  

According to Avedro, the FDA's action date deadline is March 15, 2014.  Can't wait to see what happens!  - jw