Firms say VEGF Trap-Eye submissions are planned in the U.S. later this year and in EU during 2012.
Regeneron Pharmaceuticals and Bayer HealthCare reported positive topline data from a Phase III trial evaluating VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with macular edema due to central retinal vein occlusion (CRVO). Submission of regulatory approval applications for the angiogenesis inhibitor as a treatment for CRVO are planned in the U.S. later this year and in Europe during 2011.
Data from the Galileo study showed that 60.2% of patients receiving monthly VEGF Trap-Eye injections gained at least 15 letters of vision from baseline, compared with 22.1% of patients treated using sham injections. The VEGF Trap-Eye cohort also gained an average of 18 letters of vision, compared with a mean gain of just 3.3 letters among control cohort patients. The firms claim the Galileo results support those from the similarly designed Phase III Copernicus study, which were reported in December 2010.
The Galileo data was reported just 24 hours after Regeneron and sanofi-aventis announced positive results from the Phase III Velour study evaluating the nonophthalmic formulation of aflibercept (Zaltrap™) in combination with Folfiri chemotherapy as second-line treatment for metastatic colorectal cancer (mCRC). Sanofi-aventis is Regeneron’s partner for the development of VEGF Trap in oncology applications, while Regeneron and Bayer HealthCare are collaborating on development of the ophthalmic formulation of aflibercept. Under terms of the ophthalmic diseases partnership, Bayer HealthCare will market the treatment outside the U.S. and will share with Regeneron any profits from future sales of VEGF Trap-Eye in these territories. Regeneron retains exclusive rights to VEGF Trap-Eye in the U.S.
The firms are developing VEGF Trap-Eye against ophthalmic disorders including age-related macular degeneration (wet AMD) and diabetic macular edema, as well as CRVO. Earlier this month they reported initiating Phase III clinical development of VEGF Trap-Eye in the treatment of diabetic macular edema. The first Phase III DME trial, known as Vivid-DME, is being led by Bayer HealthCare and has started in Australia. It will in addition be expanded to sites in Europe and Japan. A second Regeneron-led study named Vista-DME is expected to begin later in 2011 in the United States, Canada, and other countries.
In February Regeneron submitted a BLA to FDA for approval of VEGF Trap-Eye as a treatment for wet AMD. Earlier this month the application was granted priority review status, and an FDA ruling is expected on August 20th. The firm says Bayer plans to file regulatory submissions in Europe during the second quarter of 2011.