No Phase III development for Combination of Eylea and nesvacumab

Regeneron Pharmaceuticals, Inc. announced that results from two Phase II studies that added the angiopoietin2 (Ang2) antibody nesvacumab to Eylea (aflibercept) Injection did not provide sufficient differentiation to warrant Phase III development.

The RUBY study evaluated patients with diabetic macular edema (DME) and the ONYX study evaluated patients with wet age-related macular degeneration (wet AMD). EYLEA results were consistent with findings in previous clinical studies. There were no new safety signals in these studies. RUBY and ONYX were two, randomized, double-masked, active-controlled phase II studies designed to investigate if a combination of aflibercept and nesvacumab offered additional benefit over aflibercept monotherapy. The studies evaluated two different doses of nesvacumab in combination with aflibercept, both administered as a single co-formulated intravitreal injection, as well as aflibercept monotherapy. The primary endpoint for both trials was change in best-corrected visual acuity (BCVA) between week 12 and 36 as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.

Results from RUBY and ONYX will be further analyzed and will be submitted for presentation at a future medical congress. The combination of aflibercept and nesvacumab is being jointly developed by Regeneron and Bayer AG under a global collaboration agreement. The safety and efficacy of the potential use of a co-formulated combination of aflibercept and nesvacumab in wet AMD and DME have not been fully evaluated by any regulatory authority.