FDA Approves EYLEA (Aflibercept) 2mg Prefilled Syringe for Four Retinal Diseases

Compiled by: Holly

On August 13 (local time), Regeneron announced that the U.S. FDA had approved Eylea (aflibercept) 2 mg in a single-dose prefilled syringe for the treatment of four retinal diseases: wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO-ME), diabetic macular edema (DME), and diabetic retinopathy (DR).

It is worth noting that,Eylea is also currently the only approved drug available in pre-filled syringes for the treatment of four retinal diseases.. Single-dose injection with multiple dosing intervals facilitates easier administration and management by physicians, and better meets the individualized needs of patients.

“Through eight pivotal Phase 3 clinical trials and millions of injections administered worldwide, Eylea has set a high standard for visual acuity and safety in the treatment of various retinal diseases, including AMD and diabetic eye disease. Furthermore, this approval can help physicians use Eylea more conveniently and effectively,” said Dr. George D. Yancopoulos, President and Chief Scientific Officer of Regeneron.

Eylea, co-developed by Regeneron and Bayer, is a novel intravitreal VEGF inhibitor composed of the extracellular domains of human vascular endothelial growth factor (VEGF) receptors 1 and 2 fused to the Fc portion of human immunoglobulin G1. Eylea functions as a soluble decoy receptor for the VEGF family and placental growth factor (PlGF), binding these factors with high affinity to prevent their interaction with endogenous VEGF receptors, thereby inhibiting abnormal angiogenesis and vascular leakage. Regeneron holds exclusive rights to the drug in the United States, while Bayer holds exclusive commercialization rights in all other countries and regions.

In the United States, Eylea was approved for marketing in November 2011 and experienced rapid sales growth. In 2015, with global sales of $3.9 billion, Eylea surpassed Roche’s Lucentis (ranibizumab) to become the best-selling ophthalmic drug worldwide. In 2018, Eylea’s net sales in the U.S. market reached $4.07 billion (compared to $3.7 billion in 2017), while its global net sales amounted to $6.75 billion (compared to $5.73 billion in 2017). According to the “World Preview 2019, Outlook to 2024” report released by EvaluatePharma in June 2019, analysts projected that Eylea’s global sales would reach $7.3 billion in 2024, ranking it ninth among the world’s best-selling drugs.

Regeneron is also actively expanding the indications for Eylea. In May this year, the FDA approved an expanded indication for Eylea to treat diabetic retinopathy in patients with diabetic macular edema without diabetes. This approval was based on the Phase 3 PANORAMA clinical trial, which showed that within one year, 20% of untreated patients developed proliferative diabetic eye disease, while treatment with Eylea reduced this risk by 85%-88%. Additionally, 80% of patients receiving the Eylea 8-week dosing regimen showed significant improvement in their diabetic retinopathy.

In the United States, the approved indications for Eylea include wet age-related macular degeneration, macular edema secondary to retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patients with DME. In China, Eylea was approved on February 13, 2018, for the treatment of adult patients with DME.

Nevertheless, Eylea faces considerable pressure. Novartis’s next-generation ophthalmic product, brolucizumab (RTH258), is poised to be a formidable competitor in the wet AMD market; it is currently under review by the U.S. FDA and is expected to be launched this year. Brolucizumab is a humanized single-chain antibody fragment (scFv) that selectively inhibits VEGF, and clinical studies have demonstrated its superior efficacy over Eylea in the treatment of wet AMD.

Reference Source: FDA Approves EYLEA^® (aflibercept) Injection Prefilled Syringe