Date: 2013-10-21
Type of information: Results
phase: 3
Announcement: results
Company: Bayer Healthcare (Germany) Regeneron Pharmaceuticals (USA)
Product: Eylea® (VEGF trap eye - aflibercept)
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: macular edema following branch retinal vein occlusion (BRVO)
Therapeutic area: Ophtalmological diseases
Country:
Trial
details: The Phase 3 VIBRANT trial was a double-masked, randomized, active-controlled study of 183 patients with Macular Edema following Branch Retinal Vein Occlusion. Patients received either intravitreal Eylea® 2 mg every four weeks or laser treatment, through week 24. The primary objective of the study was to evaluate the efficacy and safety of Eylea® in improving best-corrected visual acuity compared to laser treatment at week 24. The study is ongoing through week 52.
Latest
news: * On October 21, 2013, Regeneron Pharmaceuticals has announced positive topline results for Eylea® Injection from the Phase 3 VIBRANT study in patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO). In this trial, 53% of patients who received Eylea® 2 mg every four weeks gained at least 15 letters in vision from baseline at week 24, the primary endpoint of the study, compared to 27% of patients who received laser, a standard-of-care treatment (p < 0.001). Patients who received Eylea® 2 mg every four weeks achieved a 17.0 letter mean improvement over baseline in best corrected visual acuity (BCVA) compared to a 6.9 letter mean improvement in patients who received laser (p < 0.0001), a key secondary endpoint. VIBRANT is the first Phase 3 trial in this indication in which an anti-VEGF agent was directly compared to an active comparator.
The incidence of serious adverse events (SAE) was 9.9% in the EYLEA group and 9.8% in the laser group. One death and one Anti-Platelet Trialists\' Collaboration (APTC) defined event (non-fatal stroke) occurred during the trial, both in patients in the laser group. The most common ocular adverse events in the EYLEA treated patients were conjunctival hemorrhage and eye pain. There were no cases of intraocular inflammation. There was one ocular SAE in a patient in the EYLEA group, which was a traumatic cataract.
Detailed results from this study will be presented at an upcoming medical conference.Regeneron intends to submit a regulatory application for marketing approval for macular edema following BRVO in the U.S. within the next several months.
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. Eylea® has also been approved in Europe, Japan, Australia, and in many other countries for use in wet AMD and in Europe and other countries for Macular Edema following CRVO. 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 royalty on net sales.
