Genentech, a member of the Roche group, announced encouraging results from the Phase II BOULEVARD study. In people with loss of vision from diabetic macular edema (DME), intravitreal RG7716 treatment resulted in clinically and statistically significant improvements in visual acuity gains compared to ranibizumab alone. RG7716 is the first bispecific monoclonal antibody specifically designed for the eye that binds simultaneously and inactivates the vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). These data were presented at Angiogenesis, Exudation and Degeneration 2018, a medical symposium presented by the Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine. These Phase 2 results show the potential of RG7716 for people living with diabetic macular edema, one of the main causes of vision loss in adults of working age. The BOULEVARD is a prospective, randomized, controlled, double-blind, multicentric, multidose, three-arm study and it has enrolled 229 participants in over 90 sites in the United States. The study evaluated two doses of RG7716 (1.5 mg and 6 mg) compared to the standard ranibizumab drug (0.3 mg) given as monthly intravitreal injections. The study reached its primary endpoint, demonstrating a significant improvement in the corrected correction of correct visual acuity (BCVA) at week 24 for RG7716 compared to ranibizumab in treatment-naïve patients (p=0.03, IC 80% 1.53 -5.61, pre-specified significance level: p<0.2). The secondary endpoints of the study included the evaluation of functional and anatomical measures compared to the standard of care. RG7716 was well tolerated. In addition to BOULEVARD, RG7716 is also evaluated in Phase II AVENUE and STAIRWAY studies in age-related neovascular macular degeneration (nAMD), also known as wet AMD. All the three studies have completed the enrollment and are currently undergoing follow-up. Genentech is committed to presenting data from all Phase 2 studies at upcoming medical conferences.

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