Glaukos' Epioxa Shows Durable Benefits At Three Years In Keratoconus Study

(RTTNews) - Glaukos Corporation (GKOS), an ophthalmic pharmaceutical and medical technology company, announced positive topline results from a long-term Phase 3 extension study (GLK-202-03) evaluating the durability, visual outcomes, and safety of Epioxa, the company's epi-on corneal cross-linking therapy for keratoconus, a sight-threatening corneal disease.

EPIOXA, which received FDA approval in October 2025, is a non-invasive epithelium-on corneal cross-linking treatment for keratoconus in patients aged 13 years and older.

The newly reported three-year data provide longer-term follow-up on the treatment's effects on corneal curvature and visual acuity.

Trial Details

GLK-202-03 is a long-term extension study evaluating the safety, durability and clinical outcomes of patients who completed the Phase 3 GLK-202-02 trial, following them for three years after receiving corneal cross-linking treatment during the initial study period.

Researchers followed patients for up to three years, assessing efficacy based on changes in corneal curvature and visual acuity. The study included 38 eyes from 35 patients, with 92% of eyes completing the three-year follow-up.

Key Findings

According to the company, the long-term follow-up showed durable efficacy and a favourable safety profile through three years after a single Epioxa treatment, with no additional intervention required during the extension period.

Treated eyes showed a sustained 1.9-diopter improvement in maximum corneal curvature (Kmax) from baseline, indicating long-term corneal flattening and stabilisation.

At year three, 29% of eyes gained at least two lines of best-corrected visual acuity, while 20% gained at least three lines.

The company reported no serious adverse events, treatment-related adverse events, or adverse event-related discontinuations.

CEO Quote

"These long-term results further reinforce the potential of Epioxa to provide durable clinical benefits for patients living with keratoconus," said Thomas Burns, chairman and chief executive officer of Glaukos.

Recent Quarterly Financial Performance and Guidance

In the second quarter of 2026, Glaukos reported a narrowed net loss of $18.4 million, or $0.31 per diluted share, compared to a net loss of $19.7 million, or $0.34 per diluted share, in the second quarter of 2025.

Glaukos' net sales rose 50% to $185.6 million from $124.1 million in the prior-year period.

The company ended the second quarter with approximately $289.3 million in cash and cash equivalents, short-term investments and restricted cash, and no debt.

Looking ahead, the company expects 2026 net sales to be in the range of $680 million to $700 million based on the latest foreign currency exchange rates.

Stock Performance

GKOS has traded between $73.16 and $191.62 over the last year. The stock closed Wednesday's trade at $172.18, up 6.55%.

In the overnight market, GKOS is up 1.06% at $174.

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