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news.The US Food and Drug Administration (FDA) has granted orphan drug designation to Avedro's VibeX (riboflavin ophthalmic solution) for Corneal Cross-linking to treat corneal ectasia following refractive surgery.
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The approval allows the company to use VibeX with its KXL system for treating corneal ectasia.
Avedro CEO David Muller said this second orphan drug designation and the positive clinical results from the Phase III post-Lasik ectasia study brings this technology to patients in the US.
"We 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," Muller added.
The company has also gained orphan drug designation for cross-linking for treating keratoconus.