Date: 2013-06-06
Type of information: Results
phase: 3
Announcement: results
Company: Bayer Healthcare (Germany) Regeneron Pharmaceuticals (USA)
Product: Eylea® (VEGF Trap-Eye - aflibercept ophthalmic solution)
Action
mechanism: fusion protein/VEGF receptor. 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 these cognate VEGF receptors.
Disease: myopic choroidal neovascularization (mCNV)
Therapeutic area: Ophtalmological diseases
Country:
Trial
details: MYRROR was a double-masked, sham-controlled trial that randomized 122 patients to receive either Eylea® 2 mg or sham. Patients in the active treatment arm received one initial 2 mg dose of Eylea®. Patients were evaluated every 4 weeks and were eligible to receive additionalEylea® 2 mg intravitreal injections on an as-needed (PRN) basis, determined by visual and anatomic criteria, through 20 weeks. Patients in the sham arm received monthly sham injections through week 20. Starting at week 24, patients in both arms were eligible to receive Eylea® 2 mg on a PRN basis through week 44. The primary endpoint of the study was the mean change at week 24 from baseline in best-corrected visual acuity (BCVA) as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity.
Latest
news: * On June 6, 2013, Regeneron Pharmaceuticals and Bayer HealthCare have announced positive top-line results for Eylea® (aflibercept) Injection from the Phase 3 MYRROR study in myopic choroidal neovascularization (mCNV). In this trial, patients receiving Eylea® at an initial dose of 2 milligrams (mg), followed by treatment on an as-needed (PRN) basis, had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared to a loss of 2.0 letters in patients receiving sham injections (p < 0.0001). The most common adverse events observed in the MYRROR trial that occurred with a frequency of 2% or more were conjunctival hemorrhage, dry eye, eye pain, headache and nasopharyngitis. Data from this study will be presented at an upcoming medical conference. Bayer HealthCare expects to submit the first application for regulatory approval for this indication in Asia in the second half of 2013.
Eylea® was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. Outside of the U.S., Eylea® has been approved for use in wet AMD in Japan, Australia, Europe, and several other countries.
