TARRYTOWN, NY, USA I November 27, 2017 I Regeneron Pharmaceuticals, Inc. (NASDAQ:  REGN) today 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 (wet 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,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer, Regeneron. “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 co-formulated combination of aflibercept and nesvacumab in wet AMD and DME have not been fully evaluated by any regulatory authority.

About EYLEA® (aflibercept) Injection
EYLEA® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. In the United States, EYLEA is the number one prescribed FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 studies.

Regeneron and Bayer AG collaborate on the global development and commercialization of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to six FDA-approved treatments and over a dozen product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, including VelocImmune® to yield optimized fully-human antibodies, and ambitious initiatives such as the Regeneron Genetics Center, one of the largest genetics sequencing efforts in the world.

For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

SOURCE: Regeneron Pharmaceuticals