Glaukos Corporation recently reported positive 3-year data from the long-term phase 3 extension study evaluating the durability, visual outcomes, and safety of Epioxa HD / Epioxa (riboflavin 5–phosphate ophthalmic solution 0.239% / 0.177%) for the treatment of keratoconus (KC).
Remind me about Epioxa.
Epioxa is the first and only epithelium (epi-on), minimally-invasive corneal crosslinking (CXL) therapy for the treatment of KC.
Its regulatory status:
- Approved by the FDA in October 2025,
- Commercially launched to the U.S. market in March 2026
- Received a permanent J-code in April 2026
Give me the rundown how Epioxa works.
What it is: a novel, oxygen-enriched, ultraviolet (UV)-activated, and non-invasive (epi-on) CXL approach that strengthens the cornea without needing incisional surgery (ie: a traditional CXL procedure).
- The indication: for use in epi-on corneal collagen CXL to treat KC in patients aged 13+
- The recommended dosage: available as a single-dose syringe administered via topical ophthalmic application
- This applies to both Epioxa and Epioxa HD, as per its prescribing information (which can be viewed here)
Looking for more information? Click here to check out our abbreviated rundown on everything Epioxa-related.
Didn’t I hear from Epioxa earlier this year?
Indeed. In April the company announced the publication of results from a phase 3 confirmatory pivotal trial in Ophthalmology and Therapy.
A quick summary of those findings:
- The difference in maximum corneal curvature (Kmax) between the two groups (-1.0 D [95% confidence interval (CI): -1.3 to -0.6; p < 0.0001] demonstrated statistical superiority.
- The safety profile was favorable with no serious ocular adverse events (AEs) and mild, transient treatment-emergent events.
Ultimately: KC was slowed or halted in treated eyes, while sham/placebo eyes continued to show steepening, with consistent trends across age, sex, race, and baseline severity subgroups, including eyes with mild KC.
Let’s move on to this extension study.
The long-term phase 3 extension study (GLK-202-03) followed a cohort of 35 participants (38 eyes) for 3 years after CXL treatment in Epioxa’s second phase 3 pivotal trial (GLK-202-02; NCT05759559).
- Note: 93% of eyes completed the Year 3 visit.
And these findings?
The study demonstrated durable efficacy and a favorable long-term safety profile through 3 years following a single Epioxa treatment, with no additional intervention during the extension period.
Compared to baseline, treated eyes achieved:
- Sustained 1.9 diopter (D) improvement in Kmax
- Clinically meaningful visual outcomes at Year 3, wherein:
- 29% of eyes gained two or more lines of best-corrected visual acuity (BCVA)
- 20% of eyes gained three or more lines of BCVA
Plus: Treated eyes maintained a favorable long-term safety profile through 3 years, with no:
- Serious AEs
- Treatment-related AEs
- Discontinuations due to AEs
Any comments from Glaukos?
Thomas Burns, chairman and CEO of Glaukos, noted that the "long-term results further reinforce the potential of Epioxa to provide durable clinical benefits for patients living with KC."
He added: "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."
What else should be on my watch list?
In August the company announced that it had completed patient enrollment in its U.S. pivotal clinical study supporting the potential 510(k) clearance of the PRESERFLO MicroShunt for adult patients with primary open-angle glaucoma (POAG).
Glaukos hasn’t announced an expected time for a data readout, so stay tuned for more updates!