Genentech Shows Off New Mid-Stage DME Data
An experimental mid-stage treatment is showing promise in improving vision in patients suffering from diabetic macular edema (DME).
This morning Genentech, a Roche company, announced results from its Phase II Boulevard study that shows treatment with intravitreal RG7716 resulted in clinically meaningful and visual acuity gains from baseline statistically significant improvements in visual acuity compared to Lucentis (ranibizumab). RG7716 demonstrated a significant improvement in adjusted Best Corrected Visual Acuity (BCVA) after 24 weeks of in treatment-naïve patients. Key secondary and exploratory anatomical outcomes – reduction of central retina thickness and improvements in diabetic retinopathy severity scores – were supportive of the primary outcome, Genentech said.
Genentech’s RG7716 is the first bispecific antibody designed specifically for the treatment of retinal eye diseases. The drug simultaneously binds to and inactivates vascular endothelial growth factor A (VEGF-A) and Angiopoietin-2 (Ang-2), the company said. Genentech said it intends to discuss the Phase II results with the U.S. Food and Drug Administration in order to initiate Phase III trials.
In the Phase II Boulevard study, 229 patients were dosed monthly over the course of about five months. Following the dosing of 20 weeks, Genentech said there were an additional 16 weeks of observation so researchers could see if the treatment demonstrated superior gains in visual acuity compared to ranibizumab injections at week 24 in anti-vascular endothelial growth factor (VEGF) treatment-naïve participants. Both dosing arms of RG7716 achieved higher proportions of patients gaining more than two, and more than three, lines of visual acuity.
“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,” Chief Medical Officer Sandra Horning said in a statement. “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.”
Diabetic macular edema affects approximately 750,000 people in the United States. The disease is associated with blindness and decreased quality of life when left untreated. Loss of visual function due to diabetes is the leading cause of adult-onset blindness. The longer people have diabetes, especially if it is poorly managed, the higher their risk for developing DME.
In addition to the Boulevard study, RG7716 is also being evaluated in two additional studies in neovascular age-related macular degeneration (nAMD), also known as wet AMD.