Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that Bayer Yakuhin, Ltd., Osaka, Japan, has submitted an application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for marketing authorization for Eylea, also known as VEGF Trap-Eye, for the treatment of the neovascular form of wet Age-related Macular Degeneration (wet AMD).  Regeneron and Bayer HealthCare are collaborating on the global development of Eylea for the treatment of wet AMD, Central Retinal Vein Occlusion (CRVO), Diabetic Macular Edema (DME), and myopic Choroidal Neo-Vascularization (mCNV).

“The submission of Eylea for marketing authorization in Japan so soon after our European submission confirms Bayer's and our commitment to bringing this potentially important new therapy to wet AMD patients across the globe,” said Leonard S Schleifer, MD, PhD, president and CEO of Regeneron.

The submission to MHLW is based on the positive results from two phase III trials, the View 1 study conducted in North America and the View 2 study conducted in Japan, Europe, and other countries. In these trials, all regimens of Eylea, including 2 milligrams (mg) dosed every two months (following three initial monthly doses), successfully met the primary endpoint of statistical non-inferiority compared to the current standard of care, ranibizumab 0.5 mg dosed every month, in the proportion of patients who maintained (or improved) vision over 52 weeks. A generally favourable safety profile was observed for both Eylea and ranibizumab. The most frequent ocular adverse events were conjunctival haemorrhage, macular degeneration, eye pain, retinal haemorrhage, and vitreous floaters, which were balanced across all treatment groups in both studies. There were no notable differences in non-ocular adverse events among the study arms.

Eylea was submitted for marketing approval for the treatment of wet AMD in the US in February 2011 by Regeneron and in Europe in June 2011 by Bayer HealthCare.

Bayer HealthCare will market Eylea outside the United States, where the companies will share equally the profits from any future sales of Eylea.  Regeneron maintains exclusive rights to Eylea in the United States.

The VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) programme consists of two randomized, double-masked, phase III clinical trials evaluating Eylea in the treatment of the neovascular form of wet AMD. The VIEW 1 study, which randomized 1,217 patients, is being conducted in the United States and Canada by Regeneron under a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA). The VIEW 2 study, which randomized 1,240 patients, is being conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare. The study designs are essentially identical. The primary endpoint evaluation was conducted at 52 weeks.

In each of the studies, Eylea was evaluated for its effect on maintaining and improving vision when dosed as an intravitreal injection on a schedule of 0.5 mg monthly, 2 mg monthly, or 2 mg every two months (following three monthly loading doses), as compared with intravitreal ranibizumab administered 0.5 mg every month during the first year of the studies. As-needed (PRN) dosing with both agents, with a dose administered at least every three months (but not more often than monthly), is being evaluated during the second year of each study.

Eylea is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). It is a specific and highly potent blocker of these growth factors. It is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

Regeneron and Bayer HealthCare are collaborating on the global development of Eylea with phase III programmes for the treatment of the neovascular form of wet AMD, CRVO, DME, mCNV.

Regeneron submitted a Biologics License Application (BLA) for marketing approval in wet AMD in the US in February 2011 and received a Priority Review designation. Under Priority Review, the target date for an FDA decision on the Eylea BLA is August 20, 2011. Bayer HealthCare submitted an application for marketing authorization in Europe in June 2011.

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions.

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide.

Bayer Yakuhin Ltd., is a healthcare company which combines business activities of pharmaceuticals, dermatology, Consumer Care (OTC product) and Animal Health (companion and food animal products).