Regeneron announced that results from two phase 2 studies that added the angiopoietin2 (Ang2) antibody nesvacumab to Eylea (aflibercept) injection did not provide sufficient differentiation to warrant phase 3 development. The RUBY study evaluated patients with diabetic macular edema (DME) and the ONYX study evaluated patients with wet age-related macular degeneration (AMD). Eylea results were consistent with findings in previous clinical studies. There were no new safety signals in these studies.
"We knew from the start that it would be difficult to improve on the already high bar set by Eylea, which is the market-leading branded therapy in its approved indications, providing significant improvements in vision and strong long-term outcomes in patients with wet AMD and DME," George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer, Regeneron, said in a company news release. "We expect to report results in the first half of 2018 from our Eylea phase 3 study in diabetic retinopathy, which represents a growing patient population with significant need. We also continue to invest in additional R&D approaches in ophthalmology with the goal of providing new innovations to patients with serious vision-threatening diseases."
RUBY and ONYX were two, randomized, double-masked, active-controlled phase 2 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 coformulated combination of aflibercept and nesvacumab in wet AMD and DME have not been fully evaluated by any regulatory authority.