The bispecific monoclonal antibody RG7716, which binds to and inactivates both VEGF-A and angiopoietin-2, met its primary endpoint of significant improvement in best corrected visual acuity compared with ranibizumab treatment in a phase 2 study of patients with diabetic macular edema, according to a news release from Genentech, a member of the Roche group.
Results from the BOULEVARD study were delivered at Angiogenesis, Exudation, and Degeneration 2018 hosted by Bascom Palmer Eye Institute in Miami.
Monthly intravitreal injections of either 1.5 mg or 6 mg of RG7716 or of 0.3 mg Lucentis (ranibizumab, Genentech) were given to treatment-naive patients in the prospective, randomized, double-masked study. A total of 229 participants were enrolled at more than 90 sites in the U.S. Treatment continued through 20 weeks, followed by an observation period.
At 24 weeks, adjusted mean improvement in BCVA in the 6 mg RG7716 group was 13.9 chart letters from baseline, a statistically significant difference from the ranibizumab group (P = .03), whose adjusted mean improvement in BCVA was 10.3 letters. Mean gain in the 1.5 mg RG7716 group was 11.7 letters.
“The Roche CrossMAb technology is an exciting platform for building bispecific antibodies, that is, antibodies that can bind two different targets instead of only one; in the case of RG7716, these two targets are VEGF-A and angiopoietin-2. While we can’t comment on specific future plans, the potential uses of the technology in ophthalmology are broad. You could envision the use of bispecific antibodies in many situations where there is compelling scientific rationale to target more than one pathway that contributes to disease pathogenesis,” Jason Ehrlich, MD, PhD, global head of clinical ophthalmology and senior group medical director for Genentech Product Development, told Healio.com/OSN.
RG7716 is also being evaluated in two other phase 2 trials, AVENUE and STAIRWAY, for treatment of neovascular age-related macular degeneration. – by Patricia Nale, ELS