Avedro announced that it has begun enrolling patients in a pivotal phase 3 clinical trial to evaluate the safety and efficacy of an epithelium-on corneal collagen cross-linking procedure to treat patients with progressive keratoconus.
The phase 3 clinical trial, ACP-KXL-308, is a multicenter, randomized, controlled study of a novel corneal cross-linking procedure of 275 patients with progressive keratoconus across approximately 20 sites in the United States. As is typical for FDA drug trials, investigational treatments are provided at no cost to participating patients.
“As a practitioner who has treated many patients with progressive keratoconus in previous clinical studies, the commencement of this epi-on cross-linking study represents another important milestone. This procedure, designed to eliminate the need to remove the epithelium, has the potential to be of great value to patients and practices alike,” Michael B. Raizman, MD, clinical investigator and practicing ophthalmologist at Ophthalmic Consultants of Boston, said in a company news release.
“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 and Founder of See Clearly Vision in the Washington D.C. area, said in the news 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.”
“The start of this study is exciting news for patients,” said Mary Prudden, Program Director, National Keratoconus Foundation. “We are pleased to see continued innovation in corneal cross-linking technologies and are hopeful that this research will ultimately lead to a second FDA-approved option for patients living with this rare and sight-threatening condition.”
The current list of participating study sites include Massachusetts, Ohio, Utah, Pennsylvania and Virginia. As new sites are initiated, they will be listed on clinicaltrials.gov.