FDA approves upstart's drug-device combo to treat a degenerative eye disorder

KXL System--Courtesy of Avedro

It's been a tough regulatory slog for drug-device combination startup Avedro. But now it's won FDA approval for its Photrexa Viscous, Photrexa and KXL System to treat corneal collagen cross-linking for the treatment of progressive keratoconus. This offers a first-in-class therapeutic option for this indication, which can result in blindness.

Treatment options in the U.S. for keratoconus were previously limited to corrective lenses or surgery. This procedure involves the use of riboflavin ophthalmic solutions, Photrexa Viscous and Photrexa that offer different concentrations. After one of these is dripped into the cornea, it is exposed to ultraviolet light. That causes the riboflavin to fluoresce, leading to the formation of bonds between collagen molecules or collagen cross-linking. The procedure only takes less than 15 minutes.

"This FDA approval has been highly anticipated by the keratoconus community," said Mary Prudden, Executive Director for the National Keratoconus Foundation, in a statement. "Corneal cross-linking provides patients a much-needed option to treat this debilitating disease."

Added Dr. Peter Hersh of The Cornea and Laser Eye Institute-CLEI Center for Keratoconus and the clinical trial medical monitor, "In the studies, treated eyes showed improvement in Kmax at 12 months, while in untreated eyes Kmax continued to worsen. The Photrexa formulations and the KXL system represent an invaluable new treatment option for corneal surgeons in the treatment of keratoconus patients." Kmax stands for maximum keratometry values, a measure of corneal degeneration.

The solutions and ultraviolet light device from the Waltham, MA-based company were given a complete response by the FDA twice--most recently in March 2015 and earlier in March 2014. That's despite a positive vote from the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee in February 2015. Last October, FDA resubmitted its FDA application--addressing the agency's latest questions regarding the design of the KXL device and its equivalence in the clinical study.

Founded in 2007, Avedro has raised more than $100 million in venture capital with the most recent infusion coming late last fall in a $32 million led by new investors InterWest and OrbiMed. That was earmarked at the time for U.S. commercialization, assuming an FDA approval.

"We plan to begin taking orders for the KXL System immediately, and plan to begin shipping our Photrexa products in the next few months as we ramp up our drug manufacturing," said Avedro COO and CFO Brian Roberts.

- here is the release