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Regeneron’s eye-drug combination fails in two Phase 2 studies

PBR Staff Writer Published 28 November 2017

Regeneron Pharmaceuticals announced that results from two Phase 2 studies that added the angiopoietin2 (Ang2) antibody nesvacumab to EYLEA (aflibercept) Injection did not provide enough differentiation to warrant phase 3 development.

Eylea injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye.

It is designed to inhibit the growth of new blood vessels and reduce the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF).

Ruby study assessed patients with diabetic macular edema (DME) and the Onyx study evaluated patients with wet age-related macular degeneration (wet AMD).

Ruby and Onyx are randomized, double-masked and active-controlled phase 2 trials designed to assess if a combination of aflibercept and nesvacumab offered additional benefit over aflibercept monotherapy.

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.

According to the company, 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.

As part of a global collaboration agreement, Regeneron and Bayer are involved in developing the combination of aflibercept and nesvacumab.

Regeneron has exclusive rights to Eylea in the US, while Bayer has exclusive marketing rights outside the US.

Regeneron chief scientific officer Dr George Yancopoulos said: "We knew from the start that it would be difficult to improve on the already high bar set by Eylea, which is the marketleading branded therapy in its approved indications, providing significant improvements in vision and strong long-term outcomes in patients with wet AMD and DME.”