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Better anatomical improvements seen with OPT-302 with ranibizumab vs. ranibizumab alone
Patients treated with OPT-302 from Opthea Limited plus ranibizumab demonstrated better anatomical changes over those treated with ranibizumab alone in a phase 2b study.
The international, multicenter, prospective, sham-controlled, double-masked superiority study included 366 patients with wet age-related macular degeneration who received OPT-302 0.5 mg in combination with Lucentis (ranibizumab, Genentech), OPT-302 2 mg in combination with ranibizumab or sham in combination with ranibizumab.
Patients in the 2 mg combination group saw a decrease in wet AMD total lesion area at 24 weeks of 4.33 mm2 compared with a decrease of 3.11 mm2 in the control group (P = .0137), Opthea reported in a press release. The mean choroidal neovascularization area also decreased at week 24 by 4.97 mm2 compared with 3.59 mm2 in the control group (P = .0052).
In addition, subretinal fluid was present in 18.5% of subjects in the 2 mg combination group at 24 weeks compared with 29.3% of those in the sham group, while the relative proportion of those with intraretinal fluid cysts was 16.8% in the combination group compared with 21.6% in the control group.
“Together with the previously reported superiority in visual acuity gains, the further data analyses support the primary outcome of the study and demonstrate that OPT-302 has direct mechanistic effects on wet AMD lesion pathology,” Megan Baldwin, PhD, CEO and managing director of Opthea, said in the release. “We continue to be encouraged by the positive outcomes of the further analyses of the phase 2b trial. We anticipate reporting additional outcomes from the study over the following months at international ophthalmology meetings.”
Two ocular serious adverse events were reported in the study, both in the 0.5 mg combination group, one case of endophthalmitis and one case of vitritis.