Riboflavin ophthalmic solution regulatory update

FDA issued a complete response letter for an NDA for riboflavin ophthalmic solution from Avedro for use with the company's KXL System, a UVA irradiation device, to treat keratoconus (structural degradation of the cornea) and corneal ectasia (corneal weakening) following refractive surgery. Avedro said the agency "identified a number of areas of the application which require additional information," but the company declined to disclose details. The application was under Priority Review. ...