Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG announced that VEGF Trap-Eye showed positive results in a Phase 2 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.
"The ability of VEGF Trap-Eye to significantly improve vision in patients with DME in this initial Phase 2 study is encouraging," said Dr. Kemal Malik, 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."
"The magnitude of the gain in visual acuity achieved with VEGF Trap-Eye in this Phase 2 study demonstrates the biologic activity of VEGF Trap-Eye in treating diabetic macular edema, a disease in which high levels of vascular endothelial growth factor (VEGF) are present," said Diana Do, MD, the Principal Investigator for the study and Assistant Professor of Ophthalmology at the Wilmer Eye Institute, The Johns Hopkins University School of Medicine in Baltimore, Maryland.
Patients in each of the four dosing groups receiving VEGF Trap-Eye achieved statistically significantly greater mean improvements in visual acuity (8.5 to 11.4 letters of vision gained) compared to patients receiving macular laser therapy (2.5 letters gained) at week 24 (p< 0.01 for each VEGF Trap-Eye group versus laser). VEGF Trap-Eye was generally well tolerated, and there were no drug-related serious adverse events.
The results of the Phase 2 study will be presented at the Angiogenesis 2010: Clinical Trials meeting on February 20, 2010 in Miami, Florida. Slides summarizing the data presented will be made available at that time on the Regeneron website (www.regeneron.com on the Presentations Page, under the Investor Relations section).