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Regeneron and Bayer Report Positive Results for VEGF Trap-Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO) and in Phase 2 Study in Diabetic Macular Edema (DME)
Date:12/20/2010

011, VEGF Trap-Eye could provide patients and physicians with a new treatment option for central retinal vein occlusion."

"After reporting positive results from our global Phase 3 program (VIEW 1 and VIEW 2 studies) for the treatment of the neovascular form of age related macular degeneration (wet AMD), we are pleased to also have a positive Phase 3 trial with VEGF Trap-Eye in central retinal vein occlusion, a potential second indication," said Kemal Malik, MD, Head of Global Development and member of the Bayer HealthCare Executive Committee.  "We are working diligently with Regeneron to prepare regulatory filings for VEGF Trap-Eye in wet AMD to submit in the first half of 2011."

Detailed results for COPERNICUS will be presented at the Angiogenesis Conference in Miami, Florida in February 2011.

Regeneron will receive a $10 million milestone payment from Bayer HealthCare in connection with the COPERNICUS trial meeting its primary endpoint and received a $10 million milestone payment in December 2010 for the positive VIEW 1 and VIEW 2 trial results in wet AMD.

Phase 2 DME ResultsRegeneron and Bayer HealthCare also reported 52 week follow-up results from the Phase 2 DA VINCI study in patients with diabetic macular edema (DME).  In this study, the previously reported visual acuity gains achieved with VEGF Trap-Eye treatment over 24 weeks (the primary endpoint of the study) were maintained or numerically improved up to completion of the study at week 52 in all VEGF Trap-Eye study groups, including 2mg dosed every other month. Based on these positive results, Regeneron and Bayer HealthCare are discussing plans to initiate Phase 3 studies.

In this double-masked, prospective, randomized, multi-center Phase 2 trial, entitled DA VINCI (DME And VEGF Trap-Eye: INvestigation of Clinical Impact), 221 patients with clinically significant DME with central macular involvement were random
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SOURCE Regeneron Pharmaceuticals, Inc.
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1. Bayer and Regeneron Dose First Patient in Second Phase 3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration
2. Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion
3. Enrollment Completed in Regeneron and Bayer HealthCare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration (Wet AMD)
4. Regeneron Announces Presentation at the 18th Annual Credit Suisse Healthcare Conference
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