First of two pivotal studies showed that VEGF Trap-Eye therapy significantly improved visual acuity.
Regeneron has earned a $10 million milestone payment from Bayer HealthCare on the achievement of positive topline data from a Phase III study evaluating the ophthalmic disorders candidate VEGF Trap-Eye in patients with macular edema due to central retinal vein occlusion (CRVO).
The Phase III Copernicus study, which was carried out by Regeneron, showed that 56.1% of patients treated monthly using VEGF Trap-Eye gained at least 15 letters of vision from baseline, compared with 12.3% of patients receiving sham injections. The results also showed that patients in the VEGF Trap-Eye group gained on average 17.3 letters of vision, while those treated using sham injections lost 4.0 letters on average.
Copernicus is the first of two Phase III trials in patients with macular edema CRVO population. Data from the second study, Galileo, are due to be reported in the second quarter of 2011. The Galileo study is being carried out by Bayer HealthCare.
VEGF Trap-Eye is being developed for a range of ophthalmic indications by Regeneron in partnership with Bayer HealthCare. Positive data from two Phase III trials evaluating the drug for the treatment of age-related macular degeneration (wet AMD) were reported in November and triggered another $10 million milestone payment to Regeneron during December. The firms project submitting U.S. and European regulatory filings for VEGF Trap-Eye as a treatment for wet AMD during the first half of 2011.
Announcement of positive data from the Copernicus study coincided with the firms reporting positive 52-week follow-up data from the Phase II Da Vinci study evaluating VEGF Trap-Eye in patients with diabetic macular edema (DME). The results showed that previously reported visual acuity gains demonstrated as a result of VEGF Trap-Eye therapy over the principal 24 weeks were maintained or numerically improved up to completion of the study at week 52 in all treated patients. These improvements were evident in all treated groups, including those dosed only every other month. Bayer HealthCare and Regeneron say they are now discussing plans for Phase III trials in the DME indication.
Under terms of their development agreement for VEGF Trap-Eye, Bayer HealthCare will market the treatment outside the U.S., where the firms will share equally in profits. Regeneron retains exclusive rights to VEGF Trap-Eye in the U.S.