Epioxa Now Available: FDA-Approved Keratoconus Treatment Launched by Glaukos

The first FDA-approved epithelium-on cross-linking procedure, Epioxa, is now commercially available in the United States, offering a new treatment option for patients with keratoconus. This advancement aims to address a significant necessitate for less invasive and more comfortable corneal collagen cross-linking (CXL) therapies. Epioxa utilizes a topical formulation, eliminating the need for removal of the corneal epithelium – the outermost layer of the cornea – a step traditionally associated with pain and prolonged recovery times in standard CXL procedures.

Keratoconus and the Promise of Epithelium-On CXL

Keratoconus is a progressive eye disease where the normally round cornea thins and gradually bulges outward into an irregular cone shape. This distortion can lead to blurred vision, increased sensitivity to light, and difficulty with tasks like driving. Whereas corneal transplants were once the primary treatment for advanced cases, CXL has emerged as a valuable technique to stabilize the cornea and prevent further progression of the disease. Traditional CXL involves removing the epithelium, applying riboflavin (vitamin B2) eye drops, and then exposing the cornea to ultraviolet (UV) light. Epioxa’s epithelium-on approach streamlines this process, potentially improving patient comfort and reducing recovery time.

The availability of Epioxa, manufactured by Glaukos, marks a significant step forward in keratoconus management. The therapy combines enriched oxygen and light to strengthen corneal tissue without the need for epithelial debridement. According to a press release from Glaukos, Epioxa can be ordered directly from the company or through its established specialty pharmaceutical distribution network.

Addressing Underdiagnosis and Improving Access

Alongside the commercial launch, Glaukos has announced a substantial investment in initiatives designed to increase both the diagnosis and treatment of keratoconus. These efforts recognize that a significant number of cases remain undiagnosed, leading to delayed intervention and potentially more severe vision impairment. The company’s plans include streamlined patient access support programs, a copay assistance program, and a patient assistance program specifically for uninsured individuals. Glaukos intends to launch disease awareness and detection campaigns to educate both the public and eye care professionals about the importance of early diagnosis.

“We are delighted to announce that Epioxa is now commercially available, ushering 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,” stated Thomas Burns, chairman and CEO of Glaukos, in the release. “Epioxa is designed to improve patient comfort and minimize recovery time, representing a game-changing new interventional keratoconus treatment for patients. Our teams have been diligently preparing for this launch, and we are excited to bring this innovative therapy to market for patients.”

Understanding the FDA Approval and Clinical Evidence

Epioxa received FDA approval in October 2025, following positive results from clinical trials. While specific details of the trials aren’t detailed in the current release, the approval signifies that the FDA has determined the benefits of Epioxa outweigh its risks for the intended utilize in patients with progressive keratoconus. It’s important to note that, like all medical procedures, Epioxa is not without potential side effects, and patients should discuss these with their ophthalmologist.

What Does Epithelium-On CXL Mean for Patients?

The epithelium serves as a protective barrier for the cornea. Removing it, as in traditional CXL, can cause discomfort and increase the risk of infection during the recovery period. By leaving the epithelium intact, Epioxa aims to mitigate these issues. The enriched oxygen component of the therapy is believed to enhance the penetration of riboflavin into the corneal stroma (the middle layer of the cornea), facilitating the cross-linking process. This approach could lead to faster healing, reduced pain, and a quicker return to normal activities for patients undergoing treatment.

The Role of Patient Assistance Programs

The introduction of copay and patient assistance programs by Glaukos is a crucial step towards ensuring equitable access to this new therapy. Similar programs for other ophthalmic treatments have demonstrated success in improving vision outcomes for underinsured patients, highlighting the importance of financial assistance in overcoming barriers to care. These programs can significantly reduce the out-of-pocket costs associated with Epioxa, making it more affordable for a wider range of individuals with keratoconus.

Looking Ahead: Monitoring and Further Research

With Epioxa now available, ongoing monitoring of its long-term efficacy and safety will be essential. Real-world data collected from clinical practice will provide valuable insights into the therapy’s performance across diverse patient populations. Further research may also explore the potential benefits of Epioxa in different stages of keratoconus and in combination with other treatment modalities. The availability of this new epithelium-on CXL procedure represents a promising advancement in the field of corneal disease, offering hope for improved vision and quality of life for individuals affected by keratoconus.