Avedro Announces Enrollment of First Patient in U.S. Pivotal Phase 3 Epi-on Corneal Cross-Linking Trial for Progressive Keratoconus
Clinical Study to Support Application for FDA Approval for Epi-on Corneal Cross-Linking Procedure with New Drug Formulation and Use of Oxygen
Waltham, Massachusetts, USA, Jun 18, 2018
Avedro, Inc., an ophthalmic pharmaceutical and medical device company and the world leader in corneal remodeling, today announced that it has begun enrolling patients in a pivotal Phase 3 clinical trial to evaluate the safety and efficacy of an epithelium-on (epi-on) corneal collagen cross-linking procedure to treat patients with progressive keratoconus. Keratoconus is a non-inflammatory eye condition in which the typically round dome-shaped cornea progressively thins and weakens and is the leading cause of penetrating keratoplasty (corneal transplant) in the United States1.
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 U.S. Food and Drug Administration (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,” said Michael B. Raizman, MD, clinical investigator and practicing ophthalmologist at Ophthalmic Consultants of Boston.
“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,” said Rajesh K. Rajpal, MD, Chief Medical Officer for Avedro and Founder of See Clearly Vision in the Washington D.C. area. “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.
- Borderie VM, Boelle PY, Touzeau O, et al. Predicted long-term Outcome of corneal transplantation. Ophthalmology 2009;2354-2360 Eye Bank Association of America Statistical Report, 2016
About Avedro, Inc.
Avedro is a leading commercial-stage ophthalmic medical technology company focused on treating corneal ectatic disorders and improving vision to reduce dependency on eyeglasses or contact lenses. Avedro’s proprietary Avedro Corneal Remodeling Platform strengthens, stabilizes and reshapes the cornea utilizing corneal cross-linking in minimally invasive and non-invasive outpatient procedures to treat corneal ectatic disorders and correct refractive conditions. The Avedro Corneal Remodeling Platform is comprised of Avedro’s KXL and Mosaic systems, each of which delivers ultraviolet A light, and a suite of proprietary single-use riboflavin drug formulations, which, when applied together to the cornea, induce a biochemical reaction called corneal collagen cross-linking.
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