Q&A: Insights from Rajesh K. Rajpal, MD, on an incision-free keratoconus therapy

Glaukos recently received FDA approval for its topical, incision-free therapy for keratoconus (Epioxa) that does not require removal of the corneal epithelium.¹ The treatment involves 2 sequential oxygen-enriched formulations—Epioxa HD and Epioxa—activated by UV light to slow or halt disease progression, according to the company.¹

Keratoconus, often diagnosed in patients under 30, is a progressive corneal disorder that can lead to thinning, weakening, and visual impairment, sometimes requiring corneal transplantation.¹

BREAKING NEWS: Glaukos receives FDA approval for Epioxa topical therapy for keratoconus

The agency’s approval was supported by two Phase 3 pivotal trials involving over 400 patients, which demonstrated safety, tolerability, and achievement of primary efficacy end points.^1,2 By eliminating epithelial removal, the topical, incision-free therapy provides a less invasive option compared with traditional cross-linking, offering improved patient comfort and recovery.¹

Commercial availability is expected in early 2026, according to the company.¹

The Eye Care Network sat down with Rajesh K. Rajpal, MD, ophthalmologist and founder of See Clearly Vision Group in McLean, Virginia, to discuss what this novel therapeutic means for managing keratoconus and supporting patients earlier in the disease course.

Note: Transcript edited for clarity and length.

What is the significance of this topical, incision-free therapy compared with currently available epi-off cross-linking options?

Rajesh K. Rajpal, MD: Epioxa is a transformative product that sets a new standard for keratoconus treatment. It’s the first and only FDA-approved incision-free procedure using bioactive topical drops catalyzed by supplemental oxygen and UV light, designed to slow or halt disease progression of keratoconus in a single administration. This novel orphan drug therapy provides tremendous value to patients, providers, and the health care system and reflects the significant innovations contained in a combined medical device and drug therapy. Simply put, Epioxa is more efficient, eliminates the pain associated with epithelium removal, and is associated with better quality of life, while also reducing the downstream medical costs associated with disease progression and deterioration of eyesight.

What factors may drive or limit the adoption of this novel therapeutic in practice?

Rajpal: Currently, patients experience significant barriers accessing diagnosis and treatment for keratoconus. Onset of keratoconus most often occurs in pediatric patients in their teens and ~90% of pediatric patients with keratoconus experience disease progression within 12 months if they do not receive cross-linking treatment, leading them closer to loss of visual function and potentially blindness if untreated. A significant investment in patient education and primary eye care professional education must be made to ensure patients are diagnosed and treated when corneal cross-linking can provide the greatest benefit.

Once diagnosed, patients and practices face challenges with payers regarding obtaining coverage and adequate reimbursement for treatment. In addition, there are always challenges with drugs that are new to the market, and this is especially true with drugs that treat rare diseases. I expect this to be no different with Epioxa. In order to ensure as many patients as possible are treated before they lose significant visual function, we need to do a better job supporting patients in their journey from diagnosis to treatment and support from Glaukos in this area will be critical.

There are many patients who do not proceed to treatment of the second eye citing the significant pain associated with removal of the epithelium and/or the long recovery period. Because the epithelium is left intact during the procedure, we expect that we will be able to treat more second eyes with Epioxa.

What impact might this novel therapy have on patient outcomes and their overall experience?

Rajpal: As I touched on in my response to the previous question, I expect that most patients will have an excellent experience with Epioxa both in terms of comfort and recovery time given that the epithelium will not be removed. Based on the clinical data, Epioxa will slow or halt progression of this sight-threatening disease.

REFERENCES

1. Glaukos announces FDA approval of Epioxa. News release. Glaukos. October 20, 2025. Accessed October 20, 2025. https://investors.glaukos.com/news/news-details/2025/Glaukos-Announces-FDA-Approval-of-Epioxa/default.aspx

2. Glaukos announces FDA acceptance of NDA submission for Epioxa. News release. Business Wire. February 24, 2025. Accessed February 24, 2025. https://www.businesswire.com/news/home/20250224038650/en/Glaukos-Announces-FDA-Acceptance-of-NDA-Submission-for-Epioxa%E2%84%A2