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Regeneron Reports Positive Phase 3 Data For EYLEA® (aflibercept) Injection In Macular Edema Following Branch Retinal Vein Occlusion

Stocks in this article: REGN

There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).  The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD studies in patients treated with EYLEA was 1.8% during the first year.  The incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in patients treated with EYLEA compared with 1.4% in patients receiving sham control during the first six months.

The most common adverse reactions (5% or more) noted in the U.S. prescribing information for the approved indications of EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.

Serious adverse reactions related to the injection procedure have occurred in <0.1% of intravitreal injections with EYLEA including endophthalmitis, traumatic cataract, increased intraocular pressure, and vitreous detachment.

Please see the full U.S. Prescribing Information for EYLEA at www.EYLEA.com

About the EYLEA ® (aflibercept) Injection Global Collaboration

Regeneron is collaborating with Bayer HealthCare on the global development of EYLEA.  EYLEA is currently approved for the treatment of wet AMD in approximately 50 countries outside the U.S., including Japan and Australia and countries in the E.U.

Regeneron maintains exclusive rights to EYLEA in the United States.

About Branch Retinal Vein Occlusion

Retinal Vein Occlusion is the second most common retinal vascular disorder and is a significant cause of visual impairment.  Of the two main types of retinal vein occlusion -- CRVO and BRVO -- the latter is more common.  In Branch Retinal Vein Occlusion (BRVO), a blockage occurs in the blood vessels branching from the main vein draining the retina, resulting in the release of VEGF and consequent retinal edema.

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