Glaukos Corporation, a leader in ophthalmic pharmaceuticals and medical technology, announced that the U.S. Food and Drug Administration has approved its new drug application for Epioxa, an innovative treatment for keratoconus. This condition is a rare but serious disorder of the cornea that often goes undiagnosed and untreated, posing a threat to patients’ vision. Epioxa introduces a new approach to corneal cross-linking by offering a non-invasive alternative that does not require removing the corneal epithelium, the outermost layer of the eye. Unlike traditional procedures, Epioxa is a topical treatment activated by UV light in an oxygen-enriched environment, which aims to reduce pain, simplify the treatment process, and speed recovery while delivering meaningful clinical results for patients, healthcare providers, and the medical system overall. The treatment involves two formulations, Epioxa HD and Epioxa, which are applied sequentially before UV activation during the procedure.
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Thomas Burns, chairman and chief executive officer of Glaukos, expressed enthusiasm about the FDA’s approval, emphasizing that Epioxa sets a new standard in care by being the first FDA-approved topical drug for keratoconus that avoids epithelial removal. He highlighted the design of Epioxa to enhance patient comfort and reduce recovery time, calling it a groundbreaking advancement for those suffering from the disease. Burns also acknowledged the critical contributions of clinical investigators and trial participants who helped bring this therapy to fruition. He stated that this approval is a major step forward in Glaukos’ mission to improve access to vision-saving treatments and that the company is eager to make Epioxa available to patients.
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Dr. W. Barry Lee, a corneal specialist at Eye Consultants of Atlanta and President of the Cornea Society, pointed out that keratoconus remains underdiagnosed and undertreated. He explained that current treatments require removing the corneal epithelium, which causes significant pain and long healing times, factors that discourage some patients from seeking care. Dr. Lee believes that Epioxa’s non-incisional, epithelium-sparing approach will help overcome these barriers and improve patient outcomes.
The FDA approval is supported by data from two large phase 3 clinical trials that included over 400 patients and met their primary effectiveness goals. These studies also confirmed that Epioxa has a favorable safety and tolerability profile. Glaukos plans to launch Epioxa commercially in the first quarter of 2026 and intends to invest heavily in initiatives aimed at increasing awareness, access, and diagnosis of keratoconus. Their efforts will include patient support programs, co-pay assistance to lower financial burdens, healthcare professional education, and campaigns to promote earlier and more widespread screening.
Keratoconus causes progressive thinning and weakening of the cornea, typically worsening in younger patients under 30. If untreated, it can lead to severe vision loss and is one of the leading reasons for corneal transplants in the U.S. Around 90 percent of cases affect both eyes, and up to 20 percent of untreated patients eventually need a transplant. Traditional therapies like glasses and contact lenses only correct vision but do not slow disease progression.
Glaukos’ first-generation corneal cross-linking treatment, Photrexa Viscous and Photrexa, received FDA approval in 2016 as an orphan drug and remains the only FDA-approved corneal cross-linking therapy that requires removal of the epithelium. Its safety and effectiveness are well documented in over 300 peer-reviewed studies. Epioxa represents the next generation in corneal cross-linking by offering a less invasive and more comfortable option for patients with keratoconus.
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