Avedro Announces Enrollment of First Patient in U.S. Pivotal Phase 3 Epi-on Corneal Cross-Linking Trial for Progressive Keratoconus
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 .
Avedro is a privately held pharmaceutical and medical device company and the world leader in corneal remodeling. Our patented cross-linking technology, consisting of drug formulations and medical devices, are approved for sale in numerous countries around the globe. We continue to develop proprietary corneal remodeling products for the treatment of keratoconus, corneal ectasia and for refractive correction as an alternative to contacts and eyeglasses. Keratoconus and corneal ectasia are rare and sight-threatening eye conditions in which the cornea progressively thins and weakens causing the development of a cone-like bulge and optical irregularity of the cornea which can result in significant visual impairment.
At Avedro, our mission is to produce and deliver innovative, minimally invasive drugs and devices for corneal remodeling to eyecare professionals around the world to improve patients’ vision and quality of life. For more information, visit www.Avedro.com .
- 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
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