What's Happening?
The FDA has approved Glaukos' Epioxa for treating keratoconus, a rare eye disorder. Epioxa is an incision-free alternative to traditional corneal cross-linking therapies. It uses a novel oxygen-rich therapeutic
applied topically to the cornea, activated by UV exposure, eliminating the need for surgical removal of the corneal layer. This method reduces pain and recovery time associated with traditional treatments. Keratoconus affects 50 to 200 per 100,000 people, causing the cornea to bulge outward, leading to visual impairments. Glaukos plans to launch Epioxa in the U.S. in early 2026.
Why It's Important?
The approval of Epioxa is a significant advancement in the treatment of keratoconus, offering a less invasive option compared to existing therapies. Traditional treatments often involve surgery, which can be painful and require longer recovery times. Epioxa's non-invasive approach could improve patient compliance and outcomes, reducing the need for corneal transplants, which are required in about 20% of untreated cases. This development is particularly important for younger patients, as keratoconus progresses more aggressively in individuals under 30. The approval also highlights Glaukos' innovation in ophthalmic treatments.
What's Next?
Glaukos is preparing to launch Epioxa in the U.S. market by the first quarter of 2026. The company will likely focus on educating healthcare providers and patients about the benefits of this new treatment option. As Epioxa becomes available, it may prompt further research and development in non-invasive therapies for other eye conditions. The approval could also encourage other biotech firms to explore similar approaches, potentially leading to a broader range of treatment options for keratoconus and related disorders.
