On the heels of disappointing phase 2 results, Regeneron Pharmaceuticals, Inc. says it will discontinue development of their aflibercept/nesvacumab combination therapy for diabetic macular edema (DME) and wet AMD.
Regeneron recently completed a pair of randomized, double-masked, active-controlled phase 2 trials to determine whether monotherapy with the VEGF inhibitor aflibercept outperforms an intravitreal injection of aflibercept plus varying doses of the angiopoietin2 (Ang2) antibody nesvacumab.
The trials, known as RUBY and ONYX, found no significant difference in BCVA between week 12 and 36 as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
"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, MD, PhD, president and chief scientific officer of Regeneron.
The company plans to continue studies of aflibercept monotherapy for additional indications, however. The therapy is already approved for use in patients with wet AMD, macular edema following retinal vein occlusion, DME and diabetic retinopathy in patients with DME.
"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,” Yancopoulos says. “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."