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Novel antibody yields significant VA gains in DME
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VANCOUVER, British Columbia — RG7716, a bispecific antibody designed for intraocular use, resulted in statistically significant visual acuity gains in patients with treatment-naive diabetic macular edema compared with anti-VEGF monotherapy, according to the results of a study presented here.
“Primary endpoints of both 10-letter and 15-letter gains in visual acuity favored the RG7716 group over the anti-VEGF monotherapy group. In addition, it showed improvements in both achieving a dry retina, as well as the two-step retinopathy score improvements in the study,” Rishi P. Singh, MD, said at the American Society of Retina Specialists annual meeting.
The BOULEVARD study is an ongoing prospective, randomized, controlled, double-masked phase 2 study comparing the efficacy and safety of RG7716 with Lucentis (ranibizumab, Genentech) in patients with DME who were treatment-naive or previously treated. The 229-patient cohort was randomized 1:1:1 to 6 mg intravitreal RG7716, 1.5 mg RG7716 or 0.3 mg ranibizumab. In total, 168 participants were anti-VEGF treatment-naive.
At 24 weeks, anti-VEGF treatment-naive patients in the 6 mg group experienced a mean gain from baseline in best corrected visual acuity of 13.9 letters compared with 11.7 letters in the 1.5 mg group and 10.3 letters in the ranibizumab group, a statistically significant difference of 3.6 letters (P = .03) between the ranibizumab group and the 6 mg group, Singh said.
Patients in the 6 mg group who were previously treated achieved a mean gain of 9.6 letters at 24-weeks vs. 8.3 letters in the ranibizumab group.
“Probably the more exciting result of this trial was the proportion of patients who gained two-step improvement in diabetic retinopathy score,” Singh said.
In patients with a baseline diabetic retinopathy severity score of 53 or greater, nearly 88% of patients in the 6 mg RG7716 group experienced at least a two-step improvement in that score compared with 25% of patients in the ranibizumab group, he said. – by Robert Linnehan
Reference: Singh. RP. Anti-VEGF/Anti-angiopoietin-2 bispecific antibody RG7716 in diabetic macular edema: 36-week results from the phase 2 BOULEVARD clinical trial. Presented at: American Society of Retina Specialists annual meeting; July 20-25, 2018; Vancouver, British Columbia.
Disclosure: Singh reports receiving research support from Alcon, Apellis, Genentech and Regeneron, and is a consultant/advisor to Alcon, Genentech, Regeneron and Shire.