Epi-on Crosslinking Gains FDA Approval

Keratoconus patients can achieve partial stabilization of their condition via the corneal collagen crosslinking (CXL) procedure, available internationally for decades and in the US since 2016. The standard protocol requires removal of the corneal epithelium to allow for a photosensitizing agent made of riboflavin to reach the stroma, a painful experience for patients. A beam of UV light then stimulates a reaction that strengthens collagen bonds. In the new epi-on CXL procedure, a technician applies two alternating doses of oxygen-infused riboflavin to the ocular surface for several minutes, then the patient wears goggles that deliver a continuous stream of oxygen while a light source administers UV to the cornea. Photo: Kamiya K, et al. J Clin Med. Oct 8, 2020. Click image to enlarge. Today, Glaukos announced approval of a new “oxygen-enriched” riboflavin that will allow clinics to forego corneal debridement. The topical riboflavin comes in two concentrations: 0.239% (called Epioxa HD) and 0.177% (Epioxa). The two are sequentially administered during the procedure, Glaukos says. The patient must also wear goggles during the procedures that deliver a continuous flow of oxygen to the ocular surface.Glaukos says in a press release that Epioxa is designed to improve patient comfort and minimize recovery time in hopes that the simpler procedure will motivate doctors to perform or refer for CXL more readily, as keratoconus is an underdiagnosed and undertreated condition.The FDA approval of Epioxa is based on results from two as-yet-unpublished prospective Phase III pivotal trials that randomized a total of over 400 patients. Both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles, according to the release, though no specific results were provided.Glaukos intends for Epioxa to be commercially available in the first quarter of 2026.