Glaukos Launches Epioxa: First FDA-Approved Incision-Free Topical Therapy for Keratoconus is Now Commercially Available
Epioxa Sets New Standard for Keratoconus Care—First Ever Incision-Free FDA-Approved Treatment
Glaukos Corporation (NYSE: GKOS) has launched Epioxa, now the first and only FDA-approved, incision-free topical drug therapy for keratoconus—an underdiagnosed, sight-threatening corneal disorder. Epioxa is now commercially available for order from Glaukos and select specialty distributors. This innovation introduces a non-invasive, epithelium-on, corneal cross-linking approach, marking a potential turning point in the management of keratoconus for both adult and pediatric patients aged 13 and above.
How Epioxa Works: Less Pain, Faster Recovery, More Access
Epioxa therapy utilizes riboflavin 5'-phosphate in a solution activated by enriched oxygen and light, all while keeping the corneal epithelium intact. This new approach aims to minimize pain and recovery time—two key limitations of traditional treatments involving removal of the epithelium. Such convenience can be especially valuable for patients seeking less disruptive therapy and speedier return to daily activities.
| Treatment Method | Key Characteristic | Intended Benefit |
|---|---|---|
| Incision-Free Topical (Epioxa) | Epithelium-on, No Surgery | Less pain, faster recovery |
| Traditional Cross-Linking | Epithelium-Off, Surgical | Longer recovery, more discomfort |
Patient Support, Education, and Access Initiatives Are Robust
With Epioxa's introduction, Glaukos is rolling out a suite of programs to encourage earlier diagnosis and broader access. These include a specialized patient access liaison team, co-pay and patient assistance programs, and new outreach efforts aimed at increasing both awareness and detection of keratoconus. This is designed to address a persistent challenge: underdiagnosis and undertreatment in the rare disease community, minimizing financial and logistical barriers to care.
Key Safety Information and Considerations
Epioxa is indicated for use with the O2n™ System and Boost Goggles®, targeting keratoconus in both adults and pediatric patients. The most common adverse reaction is conjunctival hyperaemia (31%). Other potential side effects (5%–25%) include corneal haze, photophobia, eye pain, and irritation. The therapy is contraindicated in patients with hypersensitivity to any ingredients, and in certain patients without a UV-blocking intraocular lens.
| Common Adverse Reactions | Frequency (%) |
|---|---|
| Conjunctival Hyperaemia | 31.00 |
| Corneal Haze/Opacity, Photophobia, Eye Pain/Irritation | 5–25 |
Takeaway: A Transformative Leap for Keratoconus Patients and Providers
The commercial rollout of Epioxa may signal a step-change for keratoconus care. By eliminating the need for incisions and streamlining the recovery process, Epioxa has the potential to expand treatment access and reshape patient experience. Glaukos’ new awareness and support initiatives may be equally consequential, targeting the underdiagnosed population and offering meaningful aid for those previously left without options.
While Epioxa’s long-term real-world impact remains to be seen, key milestones—including its FDA approval and broad access programs—suggest a move toward higher standards of care for those living with keratoconus. Patients, providers, and stakeholders will likely be watching closely as this new therapy finds its footing in the market.
For More Information
Visit www.Epioxa.com or the Glaukos investor relations page for full prescribing and safety details.
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