Eylea Injection Recommended for Approval for the Treatment of Visual Impairment due to DME in the EU

Regeneron Pharmaceuticals, Inc. has announced that Eylea (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to diabetic macular edema (DME). The decision of the European Commission is expected in the second half of 2014.

"Diabetes is a growing health concern worldwide and this milestone brings us one step closer to being able to offer patients and physicians in the EU a new therapeutic option for the treatment of DME," said George D. Yancopoulos, MD, PhD, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. 

The EU submission is based on positive data from the Phase III VIVID-DME and VISTA-DME studies.

In the Phase III VIVID-DME and VISTA-DME trials, Eylea 2 mg dosed monthly and Eylea 2 mg dosed every two months (after five initial monthly injections) both achieved the primary endpoint of significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. In these 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 the laser control group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) 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.

One-year data from the VIVID-DME and VISTA-DME trials and 2-year data from the VISTA-DME trial have been presented at medical congresses. Two-year data from the similarly designed VIVID-DME trial are expected later in 2014. Each of the VISTA-DME and the VIVID-DME trials is expected to continue as planned up to 148 weeks.

Eylea was approved in the US 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 the EU and other countries for use in wet AMD and Macular Edema following CRVO. Regulatory submissions have been made in Japan, Asia Pacific, Latin America and the US, for the treatment of DME. In Japan, Eylea has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Regulatory submissions have been made in the US and the EU for Eylea for the treatment of DME. A regulatory submission has been made in the US for Eylea for the treatment of macular edema following Branch Retinal Vein Occlusion (BRVO).

Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Ey;ea in the US. Bayer HealthCare licensed the exclusive marketing rights outside the US, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.