Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.
The company announced today that the FDA send back new inquiries for the NDA, citing "a number of areas of the application which require additional information." Avedro said that it plans to work closely with FDA officials to address any short-comings in the application.
"While we do not yet have an estimate on how long it will take to resolve the issues, we are confident that we can adequately answer their questions," Avedro CEO David Muller said in prepared remarks. "However, we continue to grow internationally by bringing advanced corneal cross-linking procedures to ophthalmologists and patients around the world."
Avedro in November 2013 won CE Mark approval in the European Union for its KXL II cross-linking system, a non-surgical treatment for myopia as well for improving cataract surgery outcomes.
The device maker had won priority U.S. review for its KXL system as a potential treatment for keratoconus and corneal ectasia. Keratoconus is a potentially blinding disease for which there are few treatment options. Corneal ectasia is a rare outcome but difficult-to-treat outcome of refractive surgery. If KXL successfully navigate the FDA approval process it would be the 1st system on the U.S. market indicated for treatment of these rare, or "orphan," conditions.
Avedro in November 2013 launched a pair of U.S. clinical trials examining cross-linking in Lasik patients and those with keratoconus. The Massachusetts company hopes to use the findings to support additional FDA approvals for Lasik with cross-linking, or Lasik Xtra, and for pulsed UVA light in treatment of keratoconus.
Cross-linking is a procedure that pairs ultraviolet light with riboflavin eye drops. The eye drops are placed on the cornea and exposed to the UV light , which spurs a molecular bond between collagen molecules. Avedro’s KXL Accelerated Cross-Linking system promises to perform the procedure "in minutes," rather than the hour-long operation usually performed.
