Regeneron says that a combination of Eylea and nesvacumab being co-developed with Bayer will not move into Phase III testing for two eye conditions following disappointing Phase II data.
The drugmaker said adding the angiopoietin2 antibody nesvacumab to Eylea (aflibercept) did not provide sufficient differentiation to warrant further development in patients with diabetic macular edema (DME) and those with wet age-related macular degeneration (wet AMD).
The studies assessed 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, but the combination failed to significantly improve the result.
“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,” said George D. Yancopoulos, president and chief scientific officer of Regeneron.
The firm is expecting to report results from a Phase III study evaluating Eylea in diabetic retinopathy, “which represents a growing patient population with significant need,” Yancopoulos noted.
