WALTHAM, Mass.--(BUSINESS WIRE)--ACOS (The American-European Congress of Ophthalmic Surgery) and Avedro, Inc. jointly announced today the initiation of a Phase 3, multi-center, randomized, controlled evaluation to study accelerated corneal collagen cross-linking in eyes with keratoconus or corneal ectasia after refractive surgery. ACOS is sponsoring the study, which will be conducted in 100 clinical centers across the United States. Each of the 100 clinical sites will use Avedro’s KXL™ System and VibeX™ (riboflavin ophthalmic solution) to treat all patients enrolled in the study.
Stephen G. Slade, MD, President of ACOS said, “In the absence of any FDA approval for corneal cross-linking, ACOS is delighted to partner with Avedro on this clinical study which allows keratoconic and ectasia patients across the United States to receive treatment from leading ophthalmic surgeons using a uniform treatment protocol and the most highly-developed technology available today.”
“Avedro is proud to be associated with ACOS and very pleased our KXL System and VibeX riboflavin will now be available to patients in 100 clinics throughout the United States as part of this study,” said David Muller, PhD, President and CEO of Avedro. “We now look forward to working with some of America’s top ophthalmologists engaged in the important clinical work of improving the sight and quality of life of thousands of keratoconus and ectasia patients.”
During 2011 Avedro completed two randomized, controlled, multi-site clinical trials designed to assess the safety and efficacy of riboflavin/ultraviolet-A light for the treatment of keratoconus and corneal ectasia following refractive surgery. Based on the positive results of those studies, Avedro recently submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for its VibeX/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery, indications which previously received US FDA Orphan Drug Status.
ACOS, a 501(c)(6) non-profit ophthalmic society, brings ophthalmologists and innovators of technologies together to advance vision care and improve the patients’ quality of life. The society was established in early 2011 and represents and educates surgeons, innovators, and industry leaders who have made a significant contribution to the field of ophthalmology. ACOS provides a platform for education and advocacy representing the mutual interests of these groups.
About Avedro, Inc.
Avedro is a privately held medical device and pharmaceutical company advancing the science and technology of corneal collagen cross-linking. Outside the United States, Avedro has commercialized both VibeX riboflavin and its KXL System for performing Lasik Xtra™ and accelerated cross-linking. Additionally, Avedro is developing the science of Thermo-biomechanics for therapeutic medical applications. The Keraflex® refractive correction procedure is the first technology developed from the Thermo-biomechanics platform and is a non-invasive, incision-less ophthalmic procedure for flattening the cornea without the removal of tissue. Keraflex, KXL, VibeX, and Lasik Xtra are CE Marked and commercially available outside of the United States.
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