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ACOS, Avedro to begin phase 3 accelerated corneal cross-linking study
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WALTHAM, Mass. — The American-European Congress of Ophthalmic Surgery will sponsor Avedro’s phase 3 study of accelerated corneal collagen cross-linking in eyes with keratoconus or corneal ectasia after refractive surgery, the company announced in a press release.
The multicenter, randomized, controlled study will be conducted in 100 clinical sites across the United States, the release said. Avedro’s KXL system and VibeX (riboflavin ophthalmic solution) will be used to treat all study participants.
“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,” OSN Refractive Surgery Board Member Stephen G. Slade, MD, president of ACOS, said in the release.
Based on successful results of two randomized, controlled, multicenter clinical trials in 2011 to assess the safety and efficacy of Avedro’s cross-linking procedure, the company submitted a new drug application to the U.S. Food and Drug Administration for the KXL and VibeX system, the release said. The system had previously been granted orphan drug status by the FDA for treatment of keratoconus and corneal ectasia following refractive surgery.
“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,” David Muller, PhD, president and CEO of Avedro, said in the release.