BioCentury
ARTICLE | Clinical News

Riboflavin ophthalmic solution regulatory update

October 26, 2015 7:00 AM UTC

Avedro resubmitted an NDA to FDA for riboflavin ophthalmic solution for use with the KXL System to treat progressive keratoconus or corneal ectasia following refractive surgery. The company expects a PDUFA date in April 2016. In March, FDA issued a complete response letter for the product asking questions regarding the design of the KXL device and the device’s equivalence to the clinical study device (see BioCentury, April 20). ...