ACOS Initiatives

ACOS (American-European Congress of Ophthalmic Surgery) is pleased to sponsor a leading accelerated cross-linking study, ACOS-KXL-001, in which 100 clinical sites will offer accelerated cross-linking throughout the US. ACOS received approval from the FDA to initiate a phase 3, multicenter, randomized, controlled evaluation of the safety and efficacy of corneal collagen cross-linking in eyes with keratoconus or corneal ectasia after refractive surgery. ACOS is sponsoring the study, and Avedro, inventor of accelerated cross-linking, will conduct it. The study exclusively utilizes Avedro’s riboflavin and KXL system for accelerated cross-linking.

Patients with keratoconus and corneal ectasia will be recruited nation-wide at 100 clinical trial sites to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with Avedro’s riboflavin and KXL System for reducing corneal curvature. Patients will be randomized to one of three treatment groups by active treatment condition (keratoconus or corneal ectasia). The study will enroll 2,000 study eyes with keratoconus and 2,000 study eyes with corneal ectasia following refractive surgery, and all fellow eyes that meet the criteria will have access to treatment. Three doses of irradiation will be tested: 15 mW/cm2 for 8 minutes, 30 mW/cm2 for 4 minutes, and 45 mW/cm2 for 2 minutes and 40 seconds. All study eyes will be treated, and all treatments will be performed with the epithelium removed.

Corneal collagen cross-linking has been commonly used as the first-line method to restore corneal stability in keratoconic and corneal ectatic eyes in Europe and throughout the world for over 13 years. The traditional therapy for cross-linking involves the application of a riboflavin solution to the eye for 30 minutes, followed by 30 minutes of UVA exposure at 3 mW/cm2. Avedro recently submitted an NDA to the US FDA for a cross-linking study at these parameters, and is starting two new trials in which accelerated cross-linking will be evaluated.