Avedro announced that the company has completed patient enrollment in a pivotal phase 3 clinical trial to evaluate the safety and efficacy of an epithelium-on (Epi-On) corneal cross-linking procedure for the treatment of progressive keratoconus. If approved, the company anticipates that its product offering would be the first FDA approved noninvasive corneal cross-linking procedure that does not require removal of the epithelium.
The pivotal phase 3 clinical trial, ACP-KXL-308, is a multicenter, randomized, sham-controlled study of a novel corneal cross-linking procedure that includes Avedro’s latest-generation UV light source, supplemental oxygen designed to enhance cross-linking and a new drug formulation designed to penetrate the epithelial layer of the cornea. The study has enrolled patients across 14 centers in the United States with more than 275 eyes included.
“Completion of patient recruitment in the Avedro Epi-On trial marks an important clinical milestone in our development pipeline and illustrates continued progress towards one of our goals—bringing innovative, FDA-approved cross-linking treatment options to patients living with progressive keratoconus,” Rajesh K. Rajpal, MD, Chief Medical Officer for Avedro and Founder of See Clearly Vision Group, Mclean, Virginia, said in a company news release. “In the three years since Avedro’s Epi-Off cross-linking treatment was FDA approved, thousands of patients have benefitted from the procedure. We are hopeful that this Phase 3 Epi-On trial will ultimately lead to another treatment option for this sight-threatening disease.”
“Avedro’s Epi-Off cross-linking procedure has become the standard of care in my practice for patients with progressive keratoconus. This new, investigative procedure, which is designed to reduce post-op discomfort and enhance recovery time, has the potential to provide added benefits to both patients and ophthalmology practices,” said George O. Waring IV, MD, FACS, Medical Monitor of the trial and Founder and Medical Director, Waring Vision Institute, Mt. Pleasant, SC.