An ophthalmic panel voted to approve Avedro’s collagen crosslinking device for keratoconus and ectasia, but the FDA did not approve the device. The Complete Response Letter involved only the device, and not the clinical aspects of the trial, and Avedro executives remain confident these last hurdles will be easily overcome.
The company is also working on LASIK Xtra, which is crosslinking with LASIK refractive surgery. There has been incredible stability shown post-procedure, with data out to 17 months in some cases, showing the refractive stability remained unchanged. Avedro is also using the device with trans-epi procedures. In one case study, a post-PRK patient underwent the procedure and vision improved from -1 to plano and 20/20.
The company has a GCP clinical trial under way; of the first 60 patients treated bilaterally, Avedro has had 100% success of hitting the standard target of +/- 0.5D. Patient stability has been consistent over time, Avedro said.
David Muller, PhD
Dr. Muller recognized the potential of using advanced methods to gently reshape the cornea and in 2007 founded Avedro, Inc., where he serves as the CEO.