Avedro, FDA reach agreement on phase 3 trial of epi-on cross-linking

Avedro and the FDA have reached a special protocol assessment agreement for the design of a pivotal phase 3 clinical trial of epithelium-on corneal collagen cross-linking for patients with progressive keratoconus, according to a press release.

According to the agreement, the trial design “adequately” addresses objectives, and if those objectives are met, they would form the basis of the submission to the FDA for approval of the epi-on cross-linking treatment.

The multicenter, randomized, controlled KXL308 phase 3 trial will evaluate the novel, accelerated cross-linking procedure in 275 subjects with progressive keratoconus, the release said. Subjects will be followed for 1 year after the procedure.

The study is expected to start at the end of the month, according to ClinicalTrials.gov, and will be completed in 2020.

“Patients in this orphan population, and practices that treat them, have truly benefited from the availability of Avedro’s FDA-approved epi-off cross-linking treatment that was launched in 2016. A new procedure that is designed to eliminate the need to remove the epithelium has the potential to be of great value to patients and practices alike, and I look forward to the start of this first-in-class pivotal phase 3 study,” Rajesh K. Rajpal, MD, Avedro’s chief medical officer, said in the release.