Regeneron's Eylea Data Unimpressive

Recently, Regeneron Pharmaceuticals, Inc. (REGN - Analyst Report) and partner Bayer (BAYRY - Analyst Report) presented not very encouraging two-year data from a couple of parallel late-stage studies (VIEW 1 and VIEW 2) of their recently approved injectable eye drug Eylea (aflibercept).

Eylea is already available in the US for treating patients suffering from the neovascular form of age-related macular degeneration (wet AMD). It was cleared by the US Food and Drug Administration (FDA) last month. The approval was based on positive 52-week results from the same studies, VIEW 1 and VIEW 2.

However, the two year data, released recently was not so impressive. Data from the two-year studies showed that Eylea was not more effective than Roche/Novartis’ (RHHBY/NVS - Snapshot Report) Lucentis (ranibizumab) in treating wet AMD. Results from an integrated analysis of the studies revealed that patients in the Eylea arm (2mg) gained an average of 7.6 letters in terms of vision with 4.2 injections during the second year as opposed to a gain of 7.9 letters with 4.7 injections during the second year for patients in the Lucentis arm.  

The failure of Eylea versus Lucentis after two years of treatment will dampen the launch of Eylea. We believe these results could make it tough for Eylea to grab market share from Roche/Novartis’ therapy. The news also adversely impacted Regeneron’s shares.

The wet AMD disorder is characterized by the growth of new blood vessels below the retina, thereby leaking blood and fluid which disrupts vision.  The eye disease is the leading cause of blindness in patients aged above 65 years in the US and Europe.

Apart from wet AMD, Bayer and Regeneron are studying Eylea for other eye-disorders such as central retinal vein occlusion, diabetic macular edema and myopic choroidal neovascularization.

Our Recommendation

Currently, we have a Neutral stance on Regeneron in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.

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