FDA to Review EYLEA (aflibercept) Injection for the Treatment of Diabetic Retinopathy

TARRYTOWN, NY, USA I September 13, 2018 I Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action date for the FDA decision is May 13, 2019.

The sBLA submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). Positive six-month topline results from PANORAMA were announced in March 2018. One-year results from PANORAMA are expected to be shared later this year.

The safety and efficacy of the potential use of EYLEA in DR without DME has not been fully evaluated by any regulatory authority.

EYLEA is administered as a 2 mg intravitreal injection and currently indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, DME, and DR in patients with DME.

About Diabetic Retinopathy

Approximately eight million people live with DR, a disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as NPDR and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and potentially cause severe, vision-threatening complications such as vitreous hemorrhage and traction retinal detachment.

DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 3.5 million people suffer from DR without DME.

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 U.S., EYLEA is the market-leading, FDA-approved anti-VEGF treatment for its approved indications and is supported by a robust body of research that includes seven pivotal Phase 3 trials.

INDICATIONS

EYLEA® (aflibercept) Injection is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR) in patients with DME.

Please visit www.EYLEA.us to see the full Prescribing Information for EYLEA.

About Regeneron

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

Regeneron is accelerating and improving the traditional drug development process through its 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

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