Regeneron Pharmaceuticals, Inc., a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions  and Bayer HealthCare, a subgroup of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry, announced that they have initiated a phase III clinical trial evaluating the efficacy and safety of Eylea (aflibercept) injection in the neovascular form of age-related macular degeneration (wet AMD) in China.

The new trial, named SIGHT, will include approximately 300 patients and will be the largest retinal trial conducted in China. SIGHT is being led by Bayer.

“Currently, only photodynamic therapy with verteporfin is approved as a treatment for wet AMD in China, and it is only approved for the subpopulation of patients with predominantly classic wet AMD,” said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee. “After reporting positive data from our large VIEW programme in wet AMD, we look forward to potentially bringing this new treatment to patients with wet AMD in China.”

The SIGHT (VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese patients with wet AMD) programme consists of a randomized, double-masked, phase III clinical trial evaluating Eylea (known in the scientific literature as VEGF Trap-Eye) in the treatment of the neovascular form of wet AMD. Eylea will be evaluated for its effect on improving and maintaining vision when dosed as an intravitreal injection on a schedule of 2 milligrams (mg) every two months (following three initial monthly doses), as compared with Photodynamic Therapy (PDT) with verteporfin. After assessment of the primary endpoint at week 28, all patients, including those on PDT, will receive Eylea treatment until the end of the study at week 52.  The SIGHT study plans to randomize 300 patients.

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs.  However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results.

Eylea, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.

Regeneron is collaborating with Bayer HealthCare on the global development of  Eylea. Bayer submitted an application for marketing authorization in Europe for wet AMD in June 2011.

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.