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First patient enrolled in phase 3 epi-on cross-linking trial

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Avedro has enrolled the first patient in a pivotal phase 3 trial of its epi-on corneal collagen cross-linking procedure for progressive keratoconus, the company announced in a press release.

The multicenter, randomized, controlled study will evaluate the safety and efficacy of the procedure in 275 patients at 20 U.S. sites.

“Since the 2016 FDA approval of Avedro’s epi-off cross-linking treatment, thousands of patients with progressive keratoconus, a potentially debilitating disease, have benefited from this procedure,” Rajesh K. Rajpal, MD, chief medical officer for Avedro, said in the release. “We are proud to continue our efforts to serve these patients and the doctors who treat them with this trial, which is the first and only epi-on study currently intended to support an FDA approval filing.”