USA-based Regeneron Pharmaceuticals and partner Bayer HealthCare of Germany announced that VEGF Trap-Eye showed positive results in a Phase II study in patients with diabetic macular edema (DME). The primary endpoint of the study, a statistically-significant improvement in visual acuity over 24 weeks compared to the standard of care in DME, macular laser therapy, was met. Visual acuity improvement was measured by the mean number of letters gained over the initial 24 weeks of the study.
Bayer gained rights to the drug in fall 2006, when it made an upfront payment of $75.0 million to Regeneron, in addition to offering a further $110.0 million based on the successful completion of developmental and regulatory milestones.
"The ability of VEGF Trap-Eye to significantly improve vision in patients with DME in this initial Phase II study is encouraging," said Kemal Malik, a member of the Bayer HealthCare executive committee responsible for global development. "Bayer and Regeneron will discuss the next steps in further developing VEGF Trap-Eye in this indication," he added.
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