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EYLEA® (aflibercept) Injection Submitted for EU Marketing Authorization for the Treatment of Patients with Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
The EMA submission is based on the positive Phase 3 VIBRANT trial, a double-masked, randomized, active-controlled study of patients with macular edema following BRVO. In the VIBRANT study, 53 percent of patients who received EYLEA 2 milligram (mg) monthly gained at least 15 letters (equivalent to three lines) in best-corrected visual acuity (BCVA) from baseline at week 24, the primary endpoint of the study, compared to 27 percent of patients who received laser, a standard of care (p < 0.001) treatment. In addition, EYLEA met a key secondary endpoint, achieving a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser (p < 0.0001).
EYLEA was generally well tolerated in this trial. Through week 24, the most common ocular adverse events in patients treated with EYLEA were conjunctival hemorrhage and eye pain. The incidence of serious adverse events (SAE) was 9.9 percent in the EYLEA group and 9.8 percent in the laser group. Up to week 24, one death and one Anti-Platelet Trialists' Collaboration (APTC) defined event (non-fatal stroke) occurred during the trial, both events occurred in patients in the laser group. There were no cases of intraocular inflammation. There was one ocular SAE in a patient in the EYLEA group, which was a traumatic cataract.
EYLEA was approved in
Regulatory submissions have also been made in the U.S. for EYLEA for the treatment of macula edema following BRVO, and in the U.S and EU for the treatment of Diabetic Macular Edema (DME).
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 BRVO, a blockage occurs in the blood vessels branching from the main vein draining the retina, resulting in the release of vascular endothelial growth factor and consequent retinal edema.
About EYLEA® (aflibercept) Injection for Intravitreal Injection
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 their cognate VEGF receptors.
IMPORTANT PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTION IN THE UNITED STATES
EYLEA® (aflibercept) Injection is indicated for the treatment of patients with neovascular (Wet) Age-related Macular Degeneration (AMD). The recommended dose for EYLEA is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
EYLEA is indicated for the treatment of patients with Macular Edema following Central Retinal Vein Occlusion (CRVO). The recommended dose for EYLEA is 2 mg administered by intravitreal injection every 4 weeks (monthly).
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA. Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported with the use of EYLEA. Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA.
Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately. 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
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in
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This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation EYLEA®
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