Key Takeaways

  • Glaukos has launched Epioxa, the first FDA-approved epithelium-on corneal cross-linking therapy

  • The therapy is designed to improve patient comfort, reduce pain, and shorten recovery time while delivering clinically meaningful outcomes

  • The company is expanding patient access and awareness efforts, including financial assistance programs and early detection initiatives

Glaukos announced the commercial availability of Epioxa HD / Epioxa, a corneal cross-linking therapy for the treatment of keratoconus. Epioxa is now available for order directly through Glaukos and its specialty pharmaceutical distribution network.

The FDA approved Epioxa HD/Epioxa in October, making it the first and only FDA-approved, incision-free, topical drug therapy for keratoconus.

“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,” said Thomas Burns, chairman and CEO of Glaukos. “Epioxa is designed to improve patient comfort and minimize recovery time, representing a game-changing new interventional keratoconus treatment.”

While traditional corneal cross-linking procedures typically require removal of the corneal epithelium, a step often associated with pain and extended recovery, Epioxa introduces an incision-free, epithelium-on approach. The therapy uses a riboflavin-based topical solution activated by enriched oxygen and light to strengthen corneal tissue. By eliminating the need for epithelial removal, the treatment is designed to reduce discomfort, streamline the procedure, and shorten recovery time while maintaining clinically meaningful outcomes.

Glaukos said it plans to expand investments in patient awareness, education, and access initiatives, including earlier screening campaigns and support programs aimed at reducing financial and logistical barriers to care. Key programs include a newly established patient access liaison team, co-pay assistance for eligible patients, and support options for uninsured individuals. These efforts are intended to guide patients from initial awareness through diagnosis and ongoing treatment.

Epioxa HD (riboflavin 5’-phosphate ophthalmic solution 0.239%) and Epioxa (0.177%) are indicated for use in epithelium-on corneal collagen cross-linking in patients aged 13 and older, when used with the O2n System and Boost Goggles. The therapy is administered topically and supplied in single-dose syringes.

The most commonly reported adverse reaction with Epioxa is conjunctival hyperemia. Other potential side effects include corneal haze, photophobia, eye irritation, and reduced visual acuity. The treatment is contraindicated in certain patients, including those with hypersensitivity to its components or without UV-blocking intraocular lenses in specific surgical conditions.

For more information, including full prescribing details, visit www.Epioxa.com.