As part of ongoing coverage of developments in keratoconus management, the Eye Care Network reached out to two clinicians to discuss the newly FDA-approved incision-free, epi-on cross-linking therapy (Epioxa; Glaukos).^1,2

Gloria B. Chiu, OD, FAAO, FSLS, associate professor of clinical ophthalmology, USC Roski Eye Institute, Keck Medicine of USC, Los Angeles, CA; and adjunct faculty, Southern California College of Optometry in Fullerton, CA, and Rajesh K. Rajpal, MD, ophthalmologist and founder of See Clearly Vision Group in McLean, VA, outlined the clinical significance of the treatment, considerations that may influence its adoption, and the potential implications for patient experience and outcomes.

A shift toward noninvasive treatment

“The recent FDA-approval of Epioxa is significant,” said Chiu. “Although the currently available FDA-approved epi-off cross-linking procedure is certainly effective in halting progressive keratoconus, the epithelium-off requirement does contribute to discomfort during the healing process and can be a source for adverse effects.”

She added that, because this is an incision-free therapy “enhanced with oxygen delivery through the O₂n System and Boost Googles,” clinicians expect to see comparable efficacy “but with less irritation and quicker recovery.” For both patients and providers, Chiu called it “a win-win.”

Rajpal described the therapy as “a transformative product [that] sets a new standard for keratoconus treatment.” He noted that it is “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.”

The platform “provides tremendous value to patients, providers and the health care system,” Rajpal said, emphasizing its efficiency and pain-free recovery. “[This therapy] eliminates the pain associated with epithelium removal and is associated with better quality of life, while also reducing downstream medical costs associated with disease progression and deterioration of eyesight.”

Adoption and access considerations

Chiu noted the transition to this protocol will be welcomed by clinicians. “I don’t believe that there will be much hesitation from eye care providers in accepting this new epi-on protocol,” she said, citing its proven efficacy and safety in Phase 3 trials. She noted that adopting the necessary devices, pharmaceutical components, and insurance processes “may require some maneuvering and persistence.

“If insurances do not promptly adopt and cover this newly approved treatment, it may be more challenging for clinics to offer,” she added.

Rajpal pointed to barriers already faced by patients with 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,” he said. “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.”

He also highlighted ongoing payer and reimbursement challenges. “Once diagnosed, patients and practices face challenges with payers regarding obtaining coverage and adequate reimbursement for treatment,” Rajpal said. “There are always challenges with drugs that are new to the market and this is especially true with drugs that treat rare diseases.”

He noted the importance of coordinated patient support: “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.”

Another benefit of the epi-on approach, Rajpal noted, is patient comfort. “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,” he said. “Because the epithelium is left intact during the procedure, we expect that we will be able to treat more second eyes with [this therapy].”

Improving outcomes and patient experience

Both experts expect the new treatment to expand access and improve quality of life. “This novel therapy should open doors for more patients with keratoconus to receive a treatment that will slow or halt their keratoconus progression,” said Chiu. She added that “advancements with this new therapy include a less invasive technique, which allows for preservation of the corneal epithelium, and likely a shorter recovery time.

“This will improve comfort during the procedure and healing process and allow patients to return to their activities of daily living sooner,” she said.

Rajpal noted that clinical data show strong outcomes. “I expect that most patients will have an excellent experience with [this therapy] both in terms of comfort and recovery time given that the epithelium will not be removed,” he said. “Based on the clinical data, [it] 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