Avedro, Inc, an ophthalmic pharmaceutical and medical device company that specializes in corneal remodeling has announced an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 clinical trial for an epithelium-on (epi-on) corneal collagen cross-linking procedure to treat patients with progressive keratoconus. The agreement provides that the Phase 3 clinical trial design, which includes clinical endpoints, trial population and statistical analyses, adequately address objectives that, if met, would form the primary basis of a regulatory submission to obtain FDA approval of Avedro’s epi-on cross-linking treatment.
The KXL308 Phase 3 clinical trial is a multicenter, randomized, controlled study comparing a novel, accelerated corneal collagen cross-linking procedure, including the use of oxygen to a control (untreated eyes), in approximately 275 subjects with progressive keratoconus. Subjects will be followed for one year. The study, as is typical for FDA drug trials, will be conducted at no cost for participating patients.
“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," said Rajesh K. Rajpal, MD, Chief Medical Officer for Avedro.
Once study enrollment begins, patients can visit clinicaltrials.gov to find a listing of participating locations.
See the full press release from Avedro, Inc.