Actionable news
0
All posts from Actionable news
Actionable news in REGN: Regeneron Pharmaceuticals, Inc.,

Regeneron Announces EU Approval of EYLEA® (aflibercept) Injection for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization

TARRYTOWN, N.Y., Oct. 30, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that Bayer HealthCare has received European approval for EYLEA® (aflibercept) Injection for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV). Myopic CNV is an eye disease associated with high degrees of myopia (near-sightedness) and frequently affects people of working age.

In the EU, EYLEA is already approved for the treatment of patients with neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, and visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO). In Japan, EYLEA is approved for the treatment of visual impairment due to myopic choroidal neovascularization, (wet) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO) and diabetic macular edema.

Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare 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 Myopic Choroidal Neovascularization
Myopic choroidal neovascularization is a disease of the retina in persons who are severely myopic (typically at least minus six diopters) and have pathological changes in the back of the eye. The disease is characterized by an abnormally elongated eye with a physical stretching of the sclera, choroid and retina, resulting in degenerative and progressive changes. These degenerative changes can induce the development of choroidal neovascularization.

About EYLEA® for Intravitreal Injection
EYLEA is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. EYLEA is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. EYLEA helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.

IMPORTANT PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTIONS IN THE UNITED STATES

EYLEA® (aflibercept) Injection is a prescription medicine approved for the treatment of patients with:

Wet Age-related Macular Degeneration (AMD): The recommended dose for EYLEA is 2 mg administered by injection in the eye every 2 months (8 weeks) following 3 initial monthly (4 weeks) injections. EYLEA may be dosed once per month, but additional benefit was not seen with this dosing plan.

Macular Edema following Retinal Vein Occlusion (RVO): The recommended dose for EYLEA is 2 mg administered by injection in the eye monthly (every 4 weeks).

Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in patients with DME:...


More