Regeneron Ending Eylea, Nesvacumab Combo Program

December 1, 2017: By Jon Swedien

Regeneron is ending the Eylea and nesvacumab combination program it had been developing with Bayer AG, the Tarrytown, New York, company announced Nov. 27.

Results from two Phase II studies that added the angiopoietin2 (Ang2) antibody nesvacumab to an Eylea (aflibercept) injection did not provide sufficient differentiation from Eylea monotherapy to warrant Phase III development, Regeneron said.

The RUBY study evaluated patients with diabetic macular edema (DME), and the ONYX study evaluated patients with wet age-related macular degeneration (wet AMD).

The randomized, double-masked studies evaluated two 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 between week 12 and 36 as measured by the Early Treatment Diabetic Retinopathy Study letter score.

Eylea results were consistent with findings in previous clinical studies, and there were no new safety signals in these studies, Regeneron said.

The combination of aflibercept and nesvacumab was being jointly developed by Regeneron and Bayer AG under a global collaboration agreement. Regeneron maintains exclusive rights to Eylea in the US, and Bayer has licensed the exclusive marketing rights outside the US, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.

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