AUG 07, 2013
Cataract/Anterior Segment, Comprehensive Ophthalmology, Cornea/External Disease, Glaucoma, Neuro-Ophthalmology/Orbit, Ocular Pathology/Oncology, Oculoplastics/Orbit, Pediatric Ophth/Strabismus, Refractive Mgmt/Intervention, Retina/Vitreous, Uveitis
Regeneron Pharmaceuticals this week reported positive results from two phase 3 trials of Eylea (aflibercept) injection for diabetic macular edema (DME). Treatment with the new anti-VEGF resulted in significantly greater improvement in BCVA compared with laser photocoagulation.
The company now expects to apply for FDA approval of Eylea for DME in 2013, about one year ahead of the previously announced timeline. Bayer Healthcare, which is collaborating with Regeneron on global development of the drug, plans to submit an application for marketing approval for the treatment of DME in Europe in 2013.
The study results were from the VIVID-DME and VISTA-DME trials in which patients with DME were randomized to treatment with Eylea 2 mg dosed monthly, Eylea 2 mg dosed every two months (after five initial monthly injections) or laser photocoagulation. Both Eylea treatment arms achieved the study’s primary endpoint of a significantly greater improvement in BCVA from baseline compared with laser photocoagulation after 52 weeks and demonstrated similar improvements in BCVA.
Eylea was approved in the U.S. for the treatment of wet AMD in November 2011 and for macular edema following central retinal vein occlusion in September 2012. Eylea has also been approved in Europe, Japan, Australia and several other countries for the treatment of wet AMD.
In the VIVID-DME trial, after one year patients receiving EYLEA 2 mg monthly had a mean BCVA change from baseline of 10.5 letters and patients receiving EYLEA 2 mg every other month (after 5 initial monthly injections) had a mean change in BCVA from baseline of 10.7 letters (P < 0.0001 compared to laser in both groups), compared to a mean change from baseline in BCVA of 1.2 letters in patients receiving laser photocoagulation.