Key Takeaways
- Eyes treated with Epioxa maintained a 1.9-D improvement in Kmax from baseline at 3 years without additional cross-linking intervention during the extension period
- At year 3, 29% of treated eyes had gained at least 2 lines of BCVA and 20% had gained at least 3 lines
- No serious adverse events, treatment-related adverse events, or discontinuations due to adverse events were reported through 3 years in the extension study
Glaukos announced positive topline results from a long-term phase 3 extension study of Epioxa, its investigational epi-on corneal cross-linking therapy for keratoconus, reporting sustained improvements in corneal curvature and visual acuity through 3 years after a single treatment.
Results from the GLK-202-03 extension study showed that treated eyes maintained a 1.9-diopter (D) improvement from baseline in maximum corneal curvature (Kmax) at 3 years. No additional cross-linking intervention was performed during the extension period, according to the company.
Visual acuity improvements were also observed at year 3. Among treated eyes, 29% gained at least 2 lines of best-corrected visual acuity (BCVA) from baseline, while 20% gained at least 3 lines.
“These long-term results further reinforce the potential of Epioxa to provide durable clinical benefits for patients living with keratoconus,” Thomas Burns, chairman and CEO of Glaukos, said in a news release. “The sustained improvements in corneal shape and visual acuity, coupled with an excellent long-term safety profile, reinforce our view that Epioxa represents a transformative treatment advancement for keratoconus patients.”
GLK-202-03 was designed to evaluate the long-term safety, durability, and clinical outcomes of patients who completed the phase 3 GLK-202-02 pivotal trial and received corneal cross-linking during that study. A total of 38 study eyes from 35 patients participated in the extension, with 92% of eyes completing the year 3 visit. Efficacy assessments focused on changes in corneal curvature and visual acuity.
According to Glaukos, the sustained 1.9-D improvement in Kmax indicates continued corneal flattening and stabilization 3 years after treatment.
The company also reported a favorable long-term safety profile. Through 3 years, there were no serious adverse events, treatment-related adverse events, or discontinuations due to adverse events among treated eyes participating in the extension study.
Epioxa is designed to treat keratoconus without removing the corneal epithelium, differentiating the therapy from conventional epithelium-off, or epi-off, corneal cross-linking.
The investigational treatment uses an oxygen-supplemented topical therapy that is bioactivated with pulsed ultraviolet light. By preserving the corneal epithelium, the approach is intended to reduce procedure-related pain and recovery associated with epithelial removal while providing corneal stabilization.
The new findings add longer-term follow-up to the efficacy and safety data generated in the GLK-202-02 pivotal trial. Glaukos said the durability observed through 3 years supports the potential for a single Epioxa treatment to provide sustained disease stabilization in patients with keratoconus.
