Eylea Treatment for Wet Macular Degeneration

Eylea ™ (VEGF Trap-Eye)

Overview Eylea Treatment for Wet Macular Degeneration (AMD)

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

Sept. 13, 2018

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.

FDA to Review EYLEA Injection for the Treatment of Diabetic Retinopathy

FDA Approves EYLEA® (aflibercept) Injection sBLA in Wet Age-related Macular Degeneration

Aug 17, 2018

Regeneron Pharmaceuticals, Inc. (NASDAQ :REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). These data are now included in the updated EYLEA label.

FDA Approves EYLEA Injection sBLA in Wet Age-related Macular Degeneration

EYLEA® (aflibercept) Submitted for EU Marketing Authorization for the Treatment of Macular Edema Following Central Retinal Vein Occlusion

EYLEA was approved in the United States for the treatment of wet AMD in November 2011 and for macular edema following CRVO in September 2012. EYLEA was also approved in Europe, Japan, Australia, and in several other countries earlier this year for use in wet AMD.

Bayer's eye drug Eylea approved in Europe

One of Eylea’s key selling points will be its less frequent dosing. Bayer’s drug is given every two months after three initial monthly injections, compared to monthly Lucentis injections.

EYLEA® (aflibercept) Injection Approved for the Treatment of Wet Age-Related Macular Degeneration in Europe

Regeneron today announced that EYLEA® (aflibercept) Injection has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD)

European Medicines Agency - Human medicines - Eylea

On 20 September 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Eylea, 40 mg/ml, solution for injection intended for the treatment of neovascular (wet) age-related macular degeneration (AMD).

FDA одобрило препарат Eylea для лечения возрастной макулярной дегенерации

Агентство по контролю за продуктами питания и лекарственными средствами США (FDA) одобрило препарат Eylea (афлиберцепт) для лечения влажной формы возрастной макулярной дегенерации

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Regeneron Wins FDA Approval for Blindness Drug Eylea

Regeneron Pharmaceuticals Inc. (REGN) won U.S. approval of Eylea, a treatment for a common cause of blindness that will rival Roche Holding AG (ROG)'s Lucentis.

U.S. FDA Approves EYLEA™ (aflibercept) Injection for the Treatment of Wet Age-Related Macular Degeneration

Regeneron Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for EYLEA™ Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).

FDA approves Eylea for eye disorder in older people

The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

Media Advisory: For Nov. 18 FDA Decision on Vision Drug, AHAF Experts Available for Comment

For the anticipated FDA announcement on November 18 regarding new treatment for macular degeneration, the American Health Assistance Foundation has experts available for comment, as well as inspiring stories of persons living with the disease.

VEGF Trap-Eye Clinical Trial Results Will Be Presented at the American Academy of Ophthalmology 2011 Annual Meeting

The comprehensive year-one findings of the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) 1 and 2 studies will be reported by Ursula Schmidt-Erfurth, MD, of the Medical University of Vienna, Austria. Results of the Controlled Phase 3 Evaluation of Repeated intravitreal administration of VEGF Trap-Eye in Central retinal vein occlusion: Utility and Safety (COPERNICUS) study will be reported by Julia Haller, MD, of the Wills Eye Institute in Philadelphia.

Eylea Treatment for Macular Degeneration

A new drug has been developed as a treatment for macular degeneration. The drug named Eylea will compete directly with Lucentis, the current leading treatment for the eye disease.

Regeneron Says FDA Delays Eylea Drug for Blindness

The drug, known as Eylea, would compete with Lucentis from Basel, Switzerland-based Roche Holding AG. (ROG) Eylea is injected every eight weeks, half as often as Lucentis

Regeneron Announces Review of Biologics License Application for EYLEA™ (aflibercept injection) Extended by Three Months by FDA

Regeneron Pharmaceuticals, Inc. today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration (wet AMD) to November 18, 2011

EYLEA (aflibercept injection) Submitted in Japan for Marketing Authorization for the Treatment of Wet Age-Related Macular Degeneration

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer Yakuhin, Ltd., Osaka, Japan, has submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan for marketing authorization for EYLEA'', also known as VEGF Trap-Eye, for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

Eylea: A New Drug for Wet Macular Degeneration

A Food and Drug Administration panel voted unanimously Friday to recommend to approve a new Regeneron Pharmaceuticals Inc. eye drug Eylea for the treatment of a condition that can lead to blindness

FDA Panel Backs Regeneron's Eye Drug Eylea For Wet-AMD

Regeneron Pharmaceuticals Inc. (REGN: News ), said Friday that a panel of the U.S. Food and Drug Administration has unanimously recommended for approval its eye medication Eylea, indicated in the treatment of Wet AMD - a severe eye disorder that results in loss of vision.

VEGF Trap-Eye

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body whose normal role is to trigger formation of new blood vessels (angiogenesis) to support the growth of the body's tissues and organs. It has also been associated with the abnormal growth and fragility of new blood vessels in the eye, which lead to the development of wet AMD.