FEB 12, 2018
Genentech announced encouraging data from an ongoing trial investigating the efficacy and safety of RG7716, a novel bispecific antibody that binds to angiopoietin 2 and VEGF.
The results, presented at the Angiogenesis, Exudation, and Degeneration 2018 symposium in Miami, suggest that treatment with intravitreal RG7716 may lead to better vision and anatomic outcomes among treatment-naïve DME patients than ranibizumab alone.
Conducted in more than 90 sites across the United States, the double-masked BOULEVARD trial enrolled 229 DME patients who were randomized to receive a high or low dose of RG7716 (1.5 mg or 6 mg) or ranibizumab (0.3 mg). All patients were treated monthly for 20 weeks, followed by a 16-week observation phase.
At week 24, patients who received high-dose RG7716 had a mean improvement of 13.9 letters from baseline, compared with 10.3 letters in the ranibizumab arm (P=0.03). Anatomic and DR severity score improvements also favored the RG7716 arms.
The investigational drug was well tolerated, and no new safety signals were observed.
RG7716 is also being evaluated in for neovascular AMD. According to the press release, Genentech will present its phase 3 plans to the FDA after a completing data assessment from this trial.