Regeneron Announces FDA Approval of Sterile Pre-filled Intravitreal Injection for EYLEA (aflibercept)

On August 14, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that global biopharmaceutical company Regeneron Pharmaceuticals announced that its ophthalmic sterile pre-filled syringe drug had received FDA approval for market launch.

Regeneron has combined its blockbuster ophthalmic drug EYLEA with a pre-filled syringe to develop a sterile, pre-filled injectable formulation. This novel intravitreal injection is expected to enhance the safety and efficacy of clinical treatment for patients with ocular diseases.

Eylea is a vascular endothelial growth factor (VEGF) inhibitor that blocks VEGF and placental growth factor involved in angiogenesis, thereby inhibiting blood vessel growth and reducing vascular permeability.

Eylea (aflibercept ophthalmic injection solution) was approved by the FDA for market launch in November 2011, primarily for the treatment of wet age-related macular degeneration (wet-AMD). The drug was co-developed by Regeneron and Bayer, with Regeneron holding exclusive marketing rights in the United States. Eylea is one of the best-selling injectable drugs worldwide, achieving global sales of $6.282 billion in 2017, half of which came from the U.S. market.

In February 2018, Eylea was approved for marketing in China for the treatment of diabetic macular edema (DME) in adults. It is the only anti-VEGF agent approved in China for the treatment of DME. Currently, the FDA has approved four indications for Eylea, including: wet age-related macular degeneration (wet-AMD), macular edema (ME) secondary to retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Ophthalmic Sterile Pre-filled Syringe Drug is a 2 mg single-dose medication primarily indicated for the treatment of the four aforementioned conditions. The pre-filled syringe technology offers a novel administration method for Eylea, simplifying the injection procedure and facilitating hospital drug management compared to traditional syringes.

Regeneron, founded in 1988 and headquartered in New York, USA, is a global leading biopharmaceutical company. The company primarily focuses on developing innovative drugs for serious diseases, providing new treatment options for patients with ocular diseases, inflammatory diseases, cancer, cardiovascular diseases, metabolic diseases, infectious diseases, and rare diseases. Regeneron was listed on the NASDAQ Stock Exchange in the United States in 1991, with the stock code REGN.

Regeneron boasts an experienced management team and drug development experts. In addition to Eylea, the company is dedicated to developing Zaltrap, a treatment for metastatic colorectal cancer, to improve clinical outcomes for patients with this disease. Furthermore, Regeneron’s Genetics Center is conducting large-scale gene sequencing efforts and leveraging its proprietary VelociSuite technology to produce high-quality antibodies.

Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, stated, “Eight pivotal Phase III clinical trials and millions of administered injections have confirmed that Eylea can safely and effectively treat a variety of retinal diseases. We believe this medication will enable clinicians to treat patients more conveniently and effectively.”

(Compiled by Xu Xiaoxue)