Recently, Regeneron Pharmaceuticals, Inc. (REGN) and partner Bayer (BAYRY) announced the commencement of a late-stage study (n~250), MYRROR, in conjunction with the Singapore Eye Research Institute (SERI).
The study is aimed at evaluating the safety and efficacy of its VEGF (vascular endothelial growth factor) trap-eye (aflibercept ophthalmic solution) therapy in patients suffering from choroidal neovascularisation (CNV) of the retina because of pathologic myopia.
The late-stage study is underway in Japan and will be extended to countries like Singapore, China, Korea and Taiwan during the course of the year. The focus on Asia is highly encouraging as Myopia is highly prevalent in the continent. The eye disease affects approximately 40% adults in countries like Singapore and Japan with almost 10% of them suffering from high myopia. The prevalence of myopia is more dominant in East Asia than in West Asia.
Myopic CNV refers to a complicated disorder involving high myopia and often leads to blindness. The disease is the second most important cause of loss of vision in Japan. The CNV market is characterized by a huge unmet need.
Currently there are no established cures for the disease. Consequently if Regeneron’s candidate is successfully developed and subsequently commercialized then it would boost the top line of the company significantly.
We note that Regeneron and Bayer are studying VEGF trap-eye for treating eye diseases other than CNV. Late last year, the partners announced positive data from late-stage studies of its VEGF trap-eye treatment for age-related macular degeneration (wet AMD).
The condition results from the growth of excess blood vessels beneath the retina which leak blood and fluid. The leakage causes the retina to function improperly thereby resulting in distortion and/or blind spots in central vision. Regeneron and Bayer expect to present additional data in February 2011 with filings in the US and Europe expected to be submitted in the first half of 2011.
Apart from wet AMD and CNV, VEGF trap-eye is also being evaluated for treating other eye disorders such as diabetic macular edema and central retinal vein occlusion. VEGF trap-eye refers to a specially purified and formulated form of VEGF trap. It is used in the intraocular treatment of retinal diseases.
Our Recommendation
Currently, we have a “Neutral” stance on Regeneron, which is supported by the Zacks #3 Rank (short-term Hold recommendation) carried by the company.
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