Regeneron, Bayer report positive Phase III results for DME treatment

Tarrytown, NY-Regeneron Pharmaceuticals Inc. and Bayer HealthCare have announced that in the Phase III VIVID-DME and VISTA-DME trials of Eylea (aflibercept) injection for treating diabetic macular edema (DME), Eylea 2 mg dosed monthly and Eylea 2 mg dosed every 2 months (after 5 initial monthly injections) achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared with laser photocoagulation at 52 weeks.

Based on discussions with the FDA, Regeneron expects to submit an application for U.S. marketing approval for Eylea in 2013, approximately 1 year earlier than previously planned. Bayer Healthcare plans to submit an application this year for marketing approval for the treatment of DME in Europe.

In the VIVID-DME and VISTA-DME trials, Eylea was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and a laser control group. Arterial thromboembolic events also occurred at similar rates across the treatment groups and the laser control group.

The most frequent ocular treatment emergent AEs (TEAEs) observed in the VIVID-DME and VISTA-DME trials included conjunctival hemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group.