Understanding Keratoconus
The FDA has approved Glaukos’ corneal treatment, Epioxa, for managing keratoconus, a rare degenerative eye disorder. The company plans to introduce the therapy to U.S. patients in the first quarter of the coming year.
Keratoconus affects an estimated 50 to 200 people per 100,000 and occurs when the cornea gradually thins and bulges outward, forming a cone-like shape instead of a smooth dome. While its underlying cause remains unclear, the condition can cause light sensitivity, distorted or double vision, and halo effects around lights. It may ultimately result in severe vision loss or complete blindness if untreated.
In its press release announcing Epioxa’s nod on Monday, Glaukos characterized keratoconus as a debilitating disorder that tends to progress most rapidly in individuals under 30 years old. While glasses and contact lenses can manage some visual symptoms, severe cases may ultimately necessitate a corneal transplant – a procedure needed by about 20% of untreated patients, according to the company.
A Noninvasive Alternative to Cross-Linking
Another available therapy is corneal cross-linking, a procedure that typically entails loosening or removing the outermost corneal layer, applying riboflavin eye drops and then activating them with a focused UV light to strengthen corneal fibers. Glaukos’ earlier treatment, Photrexa, received FDA approval in 2016 under orphan drug status and similarly required removal of the top corneal layer during the procedure.
Glaukos describes Epioxa as a noninvasive alternative to traditional corneal cross-linking. Rather than requiring the removal of the cornea’s outer layer, Epioxa delivers a new oxygen-enriched formulation applied directly to the eye’s surface and activated by UV light. This incision-free technique, the company explained, helps avoid the discomfort linked with surgery while also shortening recovery time.
Clinical Trial Results
In two phase 3 pivotal trials involving over 400 participants, Epioxa demonstrated meaningful improvements in maximum corneal curvature along with a favorable safety and tolerability profile.
A New Benchmark in Treatment
Glaukos CEO Thomas Burns said the FDA’s approval of Epioxa establishes a new benchmark in the treatment of keratoconus as the first approved topical therapy that avoids removing the corneal epithelium. He explained that Epioxa is intended to greatly enhance patient comfort and shorten recovery time, offering a transformative option for those affected by the condition.
He further expressed gratitude to the clinical researchers and participants who made the trials possible, noting that this milestone advances the company’s goal of expanding access to sight-preserving treatments. He added that Glaukos looks forward to making the therapy available to patients soon.
Looking Ahead
Beyond the immediate rollout, the FDA approval raises questions and opportunities for the future of eye-disorder treatment. First, how real-world outcomes will align with clinical-trial data remains to be seen. Monitoring for long-term safety, durability of effect, and quality-of-life impacts will be essential.
Second, the industry may now explore broader indications or expanded patient populations—pediatric patients, earlier stage disease, and combination approaches may follow, especially given the FDA’s endorsement of this pioneering therapy.
Third, the FDA approval could open doors for competitive innovation—other companies may accelerate development of next-generation therapies, making this a potentially transformative period in ophthalmology. For patients, this means not only a new option today but potentially a richer pipeline tomorrow.
Finally, from a health-economics perspective, demonstrating value—reduced downstream complications, fewer surgeries, better visual outcomes—will determine how widely the therapy is adopted. The FDA’s approval is a strong start, but ensuring access, equity and affordability will be crucial for impact.
In summary, the FDA’s approval of Glaukos’ eye-disorder therapy is a landmark in ophthalmic care. It marks the culmination of years of research, regulatory review and clinical development—and the beginning of a new chapter in patient treatment. As rollout begins and the real-world story unfolds, clinicians, patients and the industry will be watching closely.
