A joint FDA advisory panel on Tuesday recommended approval of Avedro’s combined riboflavin ophthalmic solutions and ultraviolet light irradiation for corneal collagen cross-linking. The recommendation is the last step before the FDA renders a decision on March 29.
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel heard testimony on the company’s combined riboflavin solutions and UV irradiation device, which are indicated for progressive keratoconus and corneal ectasia following refractive surgery.
On the question of “Has substantial evidence of efficacy and safety been demonstrated for the drug device combination of Photrexa Viscous and Photrexa (riboflavin ophthalmic solution) and the KXL System (UVA light) to support approval for progressive keratoconus?,” 10 panel members voted “yes,” four voted “no,” and one abstained.
On the question of “Has substantial evidence of efficacy and safety been demonstrated for the drug device combination of Photrexa Viscous and Photrexa and the KXL System to support approval for corneal ectasia following refractive surgery?,” six panel members voted “yes,” four voted “no,” four abstained, and one member did not vote.
“We are pleased with the panel recommendation, which represents an important milestone toward making this innovative therapeutic treatment available to patients with either keratoconus or corneal ectasia following refractive surgery,” David Muller, PhD, President and Chief Executive Officer for Avedro, said in a company news release. “We appreciate the opportunity to present our comprehensive findings and look forward to continuing discussions with the FDA as their review of the NDA continues.”
The advisory panel will now make its recommendations to the FDA. Although the FDA is not obligated to follow the panels’ recommendation, it usually does. The PDUFA action date is March 29, 2015.
“Obviously, it’s an important decision that allows physicians in the US to participate in, or to benefit from, technology that’s been available around the world for over a decade,” John Vukich, MD, a partner at the Davis Duehr Dean Center for Refractive Surgery in Madison, Wisconsin, said in an interview with Eyewiretoday.com. “The ability to stabilize the cornea in patients who suffer from keratoconus is a significant advantage for us to be able to offer our patients treatment modalities, and it has been proven safe in the clinical trial, and importantly, it has been proven safe in over a decade of treatment around the world.”
“(If approved), we’re very enthusiastic to have this as a new addition to our treatment option and I think it is a significant benefit for patients in the US to have this available,” Dr. Vukich added.
The Avedro new drug application submission encompasses data from three prospective, randomized, parallel-group, open-label, sham-controlled, 12-month trials conducted in the United States to determine the safety and effectiveness of riboflavin ophthalmic solutions used in conjunction with UVA irradiation for performing corneal cross-linking in eyes with keratoconus and corneal ectasia following refractive surgery. The KXL System, used in combination with riboflavin ophthalmic solutions, received orphan drug designation for both keratoconus and ectasia following refractive surgery, which may allow Avedro 7 years of market exclusivity for the KXL System and certain riboflavin ophthalmic solutions for those indications, if approved.