Aflibercept Solution for Injection into the Eye Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME)

DME is the third approved indication for aflibercept solution for injection in the U.S.

Berlin, July 30, 2014 – The U.S. Food and Drug Administration (FDA) has approved aflibercept solution for injection into the eye (EYLEA® ) for the treatment of diabetic macular edema (DME) in the U.S. Aflibercept solution for injection has already been approved under the brand name EYLEA® in many countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).

The approval of aflibercept solution for injection in DME was based on the one year data from the Phase 3 VISTA-DME and VIVID-DME trials of 862 patients, which compared aflibercept solution for injection 2 milligrams (mg) given monthly, 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In the DME studies, after one year, the mean changes in best-corrected visual acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart for the monthly and every two month treatment arms, were statistically significantly improved compared to the control group and were similar to each other. Across both trials, patients in both aflibercept solution for injection dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a percentage of net sales.

About the Phase 3 study results
In the VIVID-DME study, patients receiving aflibercept solution for injection 2 mg every other month (after 5 initial monthly injections) had a mean gain from baseline in BCVA of +10.7 letters, after Week 52. This is equivalent to a gain of more than two lines on the ETDRS eye chart. Patients receiving laser photocoagulation had a mean change from baseline in BCVA of +1.2 letters. Additionally, thirty-three percent (33.3 %) of patients receiving aflibercept solution for injection 2 mg every other month achieved an increase of at least 15 letters, a gain of three lines from baseline as one key secondary endpoint compared to the laser treatment group with only nine percent (9.1%) achieving a similar gain.

In the VISTA-DME study, patients receiving aflibercept solution for injection 2 mg every other month (after 5 initial monthly injections) had a mean gain from baseline in BCVA of +10.7 letters, after Week 52, compared to patients receiving laser photocoagulation who had a mean change from baseline in BCVA of +0.2 letters. Additionally, as reflected by one of the secondary endpoints, thirty-one percent (31.1%) of patients receiving aflibercept solution for injection 2 mg every other month achieved an increase of at least 15 letters from baseline compared to the laser treatment group with close to eight percent (7.8%) achieving a similar gain.

Further secondary endpoints in the VIVD-DME and VISTA-DME studies included the change from baseline in central retinal thickness, diabetic retinopathy severity score and vision related quality of life.

In these trials, aflibercept solution for injection was generally well tolerated with similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across treatment groups and the control group. The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME trials included conjunctival hemorrhage, eye pain, and vitreous floaters. The most common non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the control group.

EYLEA has been approved in many countries for the treatment of wet AMD and for the treatment of visual impairment due to macular edema secondary to CRVO. Regulatory submissions have been made in Asia Pacific including Japan, Latin America and Europe for the treatment of DME. In Japan, EYLEA has been additionally submitted to regulators for approval for the treatment of choroidal neovascularization secondary to pathologic myopia (myopic CNV). Furthermore a regulatory submission has been made in Europe and the U.S. for EYLEA for the treatment of visual impairment due to macular edema following branch retinal vein occlusion (BRVO).

About Diabetic Macular Edema (DME)
Diabetic Macular Edema (DME) and diabetic retinopathy (DR) are common microvascular complications in people with diabetes. Diabetic retinopathy is a disease affecting the blood vessels of the retina. DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.

Visual impairment due to DME is estimated to affect 3-4% of people with diabetes and is the most frequent cause of blindness in young and mid-aged adults in most developed countries. As the incidence of diabetes has been steadily climbing, it is projected that the number of people impacted by DME will also grow.

About VEGF and EYLEA® (aflibercept solution for injection into the eye)
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. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.

EYLEA® 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. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.

About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.

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