The US FDA has approved a new topical therapy for keratoconus, marking the first corneal cross-linking treatment that does not require surgical removal of the corneal epithelium.¹ The approval, announced by Glaukos Corporation, addresses a significant gap in treatment options for this progressive and often underdiagnosed rare disease.

Keratoconus is characterized by progressive thinning and forward protrusion of the cornea, leading to visual impairment and representing a leading indication for corneal transplantation.^2,3 The condition is bilateral in the majority of cases,^4,5 and approximately 10-20% of patients with keratoconus eventually require corneal transplantation.^6,7 Current treatment paradigms for keratoconus include prescription eyeglasses, contact lenses, and cross-linking procedures to slow disease progression when administered early. However, existing cross-linking methods require epithelial removal, which is associated with pain and extended healing times that can serve as barriers to treatment adoption.

The newly approved therapy utilizes two oxygen-enriched topical formulations applied sequentially and activated by ultraviolet light. This approach strengthens corneal tissue through cross-linking without requiring incisions or epithelial removal, distinguishing it from traditional cross-linking procedures that involve surgical removal of the cornea’s surface layer.

The FDA approval is supported by data from two prospective, randomized, multicenter, double-masked phase III pivotal trials involving more than 400 patients. Both trials met their primary efficacy endpoints. In the second confirmatory trial (evaluated at 12 months),⁸ the treatment demonstrated a maximum keratometry change of -1.0 diopters, showing statistically significant improvement compared to the control arm.⁸ The first phase III trial (NCT03442751) measured outcomes at 6 months and also successfully met its primary efficacy endpoint. The therapy exhibited favorable tolerability, with 91.5% of enrolled patients completing the 12-month trial period.⁹ Adverse events were predominantly mild and transient, with no treatment-related systemic events reported.

Commercial roll-out is expected in Q1 2026, with the company planning patient access and awareness initiatives with further details expected later this month.

References

1. Glaukos Corporation. Glaukos announces FDA approval of Epioxa. [Press Release]. 20 October 2025. Available at: https://investors.glaukos.com/ (accessed 21 October 2025).
2. Santodomingo-Rubido J, Carracedo G, Suzaki A, Villa-Collar C, Vincent SJ, Wolffsohn JS. Keratoconus: An updated review. Cont Lens Anterior Eye. 2022;45:101559. DOI: 10.1016/j.clae.2021.101559.
3. Hashemi H, Heydarian S, Hooshmand E, Saatchi M, Yekta A, Aghamirsalim M, Valadkhan M, Mortazavi M, Hashemi A, Khabazkhoob M. The prevalence and risk factors for keratoconus: A systematic review and meta-analysis. Cornea. 2020;39:263–70. DOI: 10.1097/ICO.0000000000002150.
4. Namba H, Sugano A, Murakami T, Utsunomiya H, Nishitsuka K, Konta T, Kayama T, Yamashita H. Prevalence of keratoconus and keratoconus suspect, and their characteristics on corneal tomography in a population-based study. PLoS One. 2025;20:e0308892. DOI: 10.1371/journal.pone.0308892.
5. Lucas SE, Burdon KP. Genetic and environmental risk factors for keratoconus. Annu Rev Vis Sci. 2020;6:25–46. DOI: 10.1146/annurev-vision-121219-081723.
6. Godefrooij DA, Gans R, Imhof SM, Wisse RP. Nationwide reduction in the number of corneal transplantations for keratoconus following the implementation of cross-linking. Acta Ophthalmol. 2016;94:675–8. DOI: 10.1111/aos.13095.
7. Singh RB, Parmar UPS, Jhanji V. Prevalence and economic burden of keratoconus in the United States. Am J Ophthalmol. 2024;259:71–8. DOI: 10.1016/j.ajo.2023.11.009.
8. Glaukos Corporation. Glaukos announces positive topline outcomes in phase 3 confirmatory trial for Epioxa. [Press Release]. October 16, 2024. Business Wire. Available at: https://www.businesswire.com/news/home/20241016373490/en/ (accessed 21 October 2025).
9. ClinicalTrials.gov. Study to evaluate the safety and efficacy of epi-on corneal cross-linking in eyes with progressive keratoconus. (NCT03442751). Available at: https://clinicaltrials.gov/study/NCT03442751.

Citation: FDA approves first incision-free treatment for keratoconus. touchOPHTHALMOLOGY. 21 October, 2025.

Disclosure: This article was created by the touchOPHTHALMOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.

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