FDA Denies Approval for CXL ... Again

posted May 2, 2015, 2:09 PM by Jen Weigel
Ugh.  Again, Avedro failed to secure FDA approval for CXL for KCN and post-LASIK ectasia patients. 

The study that we were involved in sought to study two things:  the riboflavin used in the procedure (drug) and the UV lamp used in the procedure (device), both of which need FDA approval before CXL could become a viable option for patients. 

Even before we completed our study, Avedro had announced a new version of the UV lamp.  Which, to me, was kind of confusing.  My thought was, why would you do that when you still have an active study going on?  But, I'm also not able to stop the tide of technological advancement.

So, from what I can seem to gather, Avedro is seeking approval for this new lamp based on the study results using the old lamp?  I think that's just adding to confusion in the FDA approval process.

Anyhow, we are STILL waiting for FDA approval for CXL.

In the meantime, how many KCN patients have I had to refer for Intacs since that is our only viable, FDA-approved treatment option?  Thank goodness I have only had to refer on patient for corneal transplant!  That's good news, I feel, because maybe that means we are diagnosing patients earlier and helping to preserve their vision! - jw