FDA panel recommends approval of riboflavin, UV for keratoconus, corneal ectasia
Amid concerns about study data and labeling, a joint panel of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel recommended approval of Avedro’s combined riboflavin ophthalmic solutions and ultraviolet light irradiation for corneal collagen cross-linking.
Photrexa Viscous (riboflavin ophthalmic solution with 20% dextran)/Photrexa (riboflavin ophthalmic solution with 0% dextran) with the KXL system (UVA light) is the first cross-linking treatment to be considered for approval in the U.S.
The riboflavin solutions and UV irradiation device are indicated for progressive keratoconus and corneal ectasia following refractive surgery.
The panel voted on the combined riboflavin solutions and UV irradiation for both indications.
On the question, “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.
Temporary member Michael W. Belin, MD, explained his “no” vote.
“I would actually hope that the FDA would approve cross-linking based on the available data and to approve riboflavin and UV for any manufacturer that uses good manufacturing practices,” Belin said. “But just based on this study, I think it was a poorly done study, and I don’t understand why, when they took over the data 5 years ago and realized it was poor, they didn’t do an additional arm to validate the data.”
On the question of whether there is substantial evidence of efficacy and safety to support approval of the solutions and UV irradiation for corneal ectasia following refractive surgery, six panel members voted yes, four voted no, four abstained and one member, Belin, did not vote.
Some members attributed their “no” votes to Avedro’s lack of data on the KXL device; the company’s IROC UV-X system was used in the clinical trial.
“No one has done the study using the device that’s been planned to be used, and we have no data as to whether or not the device works appropriately with this medication,” member Stephen S. Feman, MD, MPH, FACS, said.
During an open public hearing, several speakers referred to reports of adverse events resulting from LASIK and questioned the incidence of keratoconus. Others, including Stephen G. Slade, MD, OSN Refractive Surgery Board Member, voiced strong support for cross-linking.
Slade, representing the American-European Congress of Ophthalmic Surgery, pointed out that the literature overwhelmingly supports cross-linking as a safe and effective treatment for progressive keratoconus and corneal ectasia.
“Our society urges the panel to consider strongly the recommendation to FDA to approve this technique,” Slade said. “Cross-linking, as discussed today, this technique works. There are papers now with 10-year follow-up.”
Slade called cross-linking a “patient-friendly technique” that halts the progression of keratoconus in a vast majority of cases. “This is the pure science. This is fighting blindness,” Slade said. “Nothing could make me happier than to have a technique such as cross-linking where I can say that I have done my last graft on a keratoconus patient.” – by Matt Hasson