Glaukos receives FDA approval for Epioxa topical therapy for keratoconus

Glaukos announced that the FDA has approved the new drug application for its topical drug therapy (Epioxa HD/Epioxa) for keratoconus.^1,2 This approval makes it the first FDA-approved corneal cross-linking treatment that is incision-free and does not require removing the corneal epithelium, said the company in a prepared statement.¹

Keratoconus is a progressive corneal disorder that causes thinning and weakening of the cornea, leading to visual impairment and, in severe cases, corneal transplantation.¹ The condition is most often diagnosed in patients 30 years or younger and remains widely underrecognized and undertreated.¹

According to Glaukos, this topical drug therapy provides an alternative to traditional cross-linking by eliminating the need to remove the epithelium.¹ The therapy is based on 2 oxygen-enriched topical formulations—Epioxa HD and Epioxa—that are applied sequentially and activated by UV light, according to the statement.¹

Thomas Burns, chairman and chief executive officer of Glaukos, noted that the FDA approval “ushers in a new standard-of-care for patients suffering from keratoconus with the first FDA-approved topical drug therapy that does not require removal of the corneal epithelium.” The treatment is designed “to significantly improve patient comfort and minimize recovery time, representing a game-changing new treatment for patients suffering from keratoconus,” Burns added.¹

What this means for clinicians and their patients

In an exclusive quote with the Eye Care Network, Rajesh K. Rajpal, MD, founder of See Clearly Vision Group in McLean, VA, noted that this novel topical drug therapy “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,” Rajpal said to the Eye Care Network. “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, [this therapy] 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.”

The FDA’s approval was supported by data from 2 prospective, randomized, multicenter, double-masked Phase 3 pivotal trials involving more than 400 patients.¹ The trials both reached their primary effectiveness targets and exhibited positive safety and tolerability outcomes.¹

The company noted it expects commercial availability to begin during the first quarter of 2026.¹ Additionally, the company noted it is focusing on raising patient awareness, improving access, and addressing the challenges of underdiagnosis and undertreatment in this rare disease community.¹ Key programs include easier access to therapy, co-payment assistance to reduce costs, education and engagement initiatives for both health care professionals and patients, and broader awareness and screening campaigns to promote earlier and more widespread diagnosis.

Glaukos’ initial corneal cross-linking treatment (Photrexa Viscous/Photrexa)—requiring the removal of the corneal epithelium—received orphan drug approval from the FDA in 2016.¹

Further information about the FDA approval will be provided during an upcoming third-quarter 2025 earnings call on October 29, 2025, at 4:30 pm ET, according to the company.¹ In addition, full prescribing information will be available at www.Epioxa.com.

References:

1. Glaukos announces FDA approval of Epioxa. News release. Glaukos. October 20, 2025. Accessed October 20, 2025.

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