Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema
- RG7716 is the first bispecific antibody designed specifically for the treatment of retinal eye diseases
- RG7716 demonstrated clinically meaningful and statistically significant improvements in visual acuity
- Key secondary and exploratory anatomical outcomes were supportive of the primary outcome
- Phase III program will be discussed with the FDA following data assessment from Phase II studies
February 12, 2018 01:00 AM Eastern Standard Time
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced encouraging results from the Phase II BOULEVARD study. In people with vision loss from diabetic macular edema (DME), treatment with intravitreal RG7716 resulted in clinically meaningful and statistically significant improvements in visual acuity gains compared with ranibizumab alone. Key secondary and exploratory anatomical outcomes – reduction of central retina thickness and improvements in diabetic retinopathy severity scores – were supportive of the primary outcome. RG7716 is the first bispecific, monoclonal antibody specifically designed for the eye that simultaneously binds to and inactivates 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 Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine, part of the University of Miami Health System.
“For the first time in diabetic macular edema, a clinically meaningful and statistically significant improvement in visual acuity compared to anti-VEGF alone has been demonstrated by simultaneously neutralizing both Angiopoietin-2 and VEGF-A with a bispecific antibody,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These Phase II results show the potential of RG7716 for people living with diabetic macular edema, a leading cause of vision loss in working-age adults. There remains a significant unmet medical need for more efficacious and longer lasting therapies for diabetic macular edema.”…..
Source: Business Wire
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