FDA Approves Glaukos' Epioxa for Rare Eye Disorder Keratoconus

The U.S. Food and Drug Administration (FDA) has granted approval to Glaukos Corporation for Epioxa, a novel treatment for keratoconus, a rare and potentially blinding eye disorder. This breakthrough therapy offers an incision-free alternative to traditional corneal cross-linking procedures, potentially revolutionizing treatment options for patients suffering from this debilitating condition.

A New Approach to Keratoconus Treatment

Keratoconus, affecting 50 to 200 individuals per 100,000 people, is characterized by the outward bulging of the cornea, causing it to resemble a cone rather than its typical dome shape. This structural change leads to various visual defects, including light sensitivity, double vision, and distorted vision. If left untreated, keratoconus can progress to blindness, with approximately 20% of untreated patients ultimately requiring corneal transplants.

Epioxa represents a significant advancement in keratoconus treatment. Unlike previous therapies that required surgical removal or loosening of the topmost corneal layer, Epioxa utilizes a novel oxygen-rich therapeutic applied topically to the cornea. This approach eliminates the need for incisions, potentially reducing pain and minimizing recovery time for patients.

Clinical Efficacy and Safety Profile

The FDA's approval of Epioxa is based on the results of two Phase III pivotal studies involving over 400 patients. These trials demonstrated that Epioxa effectively improved maximum corneal curvature while maintaining a tolerable safety profile. This data suggests that Epioxa could provide a safer and more comfortable treatment option for individuals with keratoconus, particularly those under 30 years of age, who are most at risk for aggressive disease progression.

Market Availability and Impact

Glaukos anticipates launching Epioxa in the United States market during the first quarter of 2026. This new treatment option is expected to significantly impact the management of keratoconus, potentially reducing the need for more invasive procedures such as corneal transplantation. As the first incision-free alternative for corneal cross-linking, Epioxa may improve treatment accessibility and patient outcomes for those affected by this rare eye disorder.