Regeneron Commence Study of VEGF Trap-Eye for CVRO Treatment

July 31, 2009

Regeneron Pharmaceuticals, Inc. has announced that the company has enrolled the first patient in the Phase 3 program of VEGF Trap-Eye for the treatment of central retinal vein occlusion (CRVO). This enrollment and dosing of the first patient triggered a $20 million milestone payment from Bayer.

VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare AG for the potential treatment of eye diseases such as wet AMD, DME, and CRVO.  VEGF Trap-Eye is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). Investigational VEGF Trap-Eye is a specific blocker of VEGF-A and PlGF that has been demonstrated in preclinical models to bind these growth factors with greater affinity than their natural receptors.

The Phase 3 program consists of 2 one-year clinical studies. The COPERNICUS (COntrolled Phase 3 Evaluation of Repeated iNtravitreal administration of VEGF Trap-Eye In Central retinal vein occlusion: Utility and Safety) study is being led by Regeneron and the GALILEO (General Assessment Limiting InfiLtration of Exudates in central retinal vein Occlusion with VEGF Trap-Eye) study is being led by Bayer HealthCare. The patients in both studies will receive 6 monthly injections of either VEGF Trap-Eye at a dose of 2 mg or sham injections. The primary endpoint for both is improvement in visual acuity compared with baseline after the six months of treatment. After that, patients will be treated on a PRN basis for 6 more months; all patients are eligible for rescue laser treatments. Results are expected in 2011.

Regeneron also announced that enrollment in the Phase 2 DA VINCI study of VEGF Trap-Eye in diabetic macular edema (DME) has been completed and data are expected during the first half of 2010.

Read the release.




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