FDA Grants Orphan Drug Status for Avedro's VibeX
Corneal ectasia is a rare outcome of refractive surgery but is a progressive condition that is difficult to manage.
Peter Hersh, a medical monitor for Avedroâ€™s clinical trials, said: "Avedro has yet again hit a major milestone in its efforts to make this clinically important treatment available to US patients. US ophthalmologists will be encouraged by this progress, as today they lack any approved therapeutic treatment to halt the progression of ectasia following refractive surgery."
Orphan drug designation may entitle Avedro to seven years of US marketing exclusivity upon regulatory approval.
David Muller, CEO of Avedro, said: â€œThis second orphan drug designation, along with the encouraging clinical results from our Phase III post-Lasik ectasia study, is an important commercial milestone and brings us one step closer toward bringing this exciting technology to patients in the US.
â€œWe look forward to working with the FDA as we progress towards our NDA submission. In the meantime, we are ramping up our ex-US commercialization and initiating new US trials to expand the indications for our KXL System.â€
Avedro has also received orphan drug designation for cross-linking for the treatment of keratoconus. The company anticipates submitting a filing to the FDA in the first quarter of 2012, and, if approved, will have exclusive rights to commercialize in the US.
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