Avedro said today that it won a date with the FDA next week for its corneal cross-linking technology for treating a pair of eye conditions.
A joint meeting of the watchdog agency’s Dermatologic & Ophthalmic Drugs Advisory Committee and its Ophthalmic Devices Panel is slated for Feb. 24, Boston-based Avedro said.
The joint panel will consider Avedro’s bid for approval for its KXL system, which uses riboflavin ophthalmic solutions with UVA irradiation to treat progressive keratoconus or corneal ectasia, according to a press release.
"We believe notification of the FDA advisory committee meeting represents continued progress toward our goal of obtaining U.S. approval for cross linking with our KXL system to treat patients with either keratoconus or corneal ectasia following refractive surgery," Avedro president & CEO David Muller said in prepared remarks. "We look forward to discussing the efficacy and safety data included in our submission with the committee and the FDA review team in order to bring our Avedro cross-linking platform to the United States, if approved.”
Avedro’s new drug application is backed by a trio of clinical studies, the company said. The KXL system won orphan drug status from the FDA, Avedro said, meaning it will enjoy 7 years of market exclusivity should the agency approve it for the U.S.
Earlier this year Avedro named former Insulet (NSDQ:PODD) CFO Brian Roberts to be its new finance chief. Last September the company acquired Zug, Switzerland-based Iroc Innocross and its own cross-linking technology for an undisclosed amount.