Regeneron's Eylea Injection Receives FDA Approval for Third Indication

Last week, the FDA approved the eye drug, Aflibercept (Eylea, Regeneron Pharmaceuticals) for treatment of diabetic macular edema (DME) following positive Phase 3 clinical trial data.

Eylea has already been approved for two other indications — treatment of neovascular age-related macular degeneration (wet AMD) in 2011 and macular edema following central retinal vein occlusion (CRVO) in 2012. Eylea is a vascular endothelial growth factor (VEGF) inhibitor, which is formulated as an injection for the eye and is for prescription use only. Eylea is currently available as a single, 2 mg strength injection for all indications.

Eylea’s U.S. approval for DME is based on one-year data from two Phase 3 studies (VISTA-DME and VIVID-DME). However, Regeneron will continue these studies for a total of three years, and recently announced the positive two-year results in the Phase 3 VIVID-DME trial.  George D. Yancopoulos, M.D., Ph.D., CSO of Regeneron and President of Regeneron Laboratories said, "Our clinical studies have demonstrated that treatment with Eylea can help improve and maintain vision with every 8 week dosing after 5 initial monthly doses. Eylea is the first VEGF inhibitor approved for dosing on a less than monthly basis for the treatment of DME."

DME is one of the leading causes of vision impairment which commonly affects patients suffering from diabetes. Regeneron mentions in its press release that out of 29.1 million diabetic adults in the U.S., about 1.5 million have been diagnosed with DME, while another 1 million cases remain undiagnosed.  According to the American Diabetes Association, about 7 percent of all patients with diabetes will develop DME during their lifetime. The treatable global population for DME is estimated at about 6.2 million people.

Eylea has also been recently recommended for approval in the EU for the treatment of DME, and it is expected that Eylea will gain EU approval in the second half of 2014. In Japan, Eylea has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV).  A regulatory submission has also been made in the U.S. and EU for yet another indication of Eylea- for the treatment of macular edema following branch retinal vein occlusion (BRVO).

Regeneron is collaborating with Bayer Healthcare for the global development and commercialization of Eylea. Regeneron holds exclusive rights to sell Eylea within the United States, while Bayer has exclusive commercialization rights to Eylea outside the U.S. Both companies equally share the profits from global sales of Eylea, except for Japan, where Regeneron receives a percentage of Eylea’s net sales.

Eylea is currently marketed for the treatment of wet AMD in over 50 countries, including Japan and Australia. In 2013, global revenues for Eylea were $1.9 billion, while U.S. revenues for Eylea were $1.4 billion, up 68 percent year over year.