EYLEA® (aflibercept) Injection Approved in Europe for the Treatment of Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
, /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: ) today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO).
"We are pleased with the approval of EYLEA in the E.U. in a second indication," said , M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Our Phase 3 studies showed that EYLEA improved visual outcomes significantly in Macular Edema following CRVO. This additional approval of EYLEA is great news for patients in suffering from Macular Edema following CRVO, a debilitating disease affecting central vision."
EYLEA was approved in for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in and for Macular Edema following CRVO in . EYLEA has also been approved in , , , and in several other countries for use in wet AMD and in selected countries in for Macular Edema following CRVO.
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in . Bayer HealthCare licensed the exclusive marketing rights outside , where the companies share equally the profits from sales of EYLEA, except for where Regeneron receives a royalty on net sales.
Over 66,000 people in major European countries and more than 100,000 people in are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal damage and loss of vision. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment may help decrease vascular permeability and edema in the retina in patients with CRVO.
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. In Central Retinal Vein Occlusion (CRVO), a blockage occurs in the main blood vessel that transports deoxygenated blood away from the retina. VEGF levels are elevated in response contributing to macular 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. 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.
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).
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.
Regeneron is collaborating with Bayer HealthCare on the global development of EYLEA. EYLEA is currently marketed for the treatment of wet AMD in over 15 countries outside the U.S., including and and countries in the E.U.
Regeneron maintains exclusive rights to EYLEA in .
Regeneron is a leading science-based biopharmaceutical company based in that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets 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, allergic asthma, and atopic dermatitis. For additional information about the company, please visit www.regeneron.com.
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 (2012), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, . 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 55,300 employees () and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
Your Investor Relations Contact at Regeneron:E-Mail: email@example.com
Your Media Contact at Regeneron:E-Mail: firstname.lastname@example.org
Your Contact at Bayer:E-Mail: email@example.com