Sozinibercept combination therapy shows durability in patients with DME, neovascular AMD
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Sozinibercept, a VEGF-C and -D “trap” inhibitor, showed improved durability in patients with retinal diseases when delivered as a combination therapy vs. anti-VEGF-A monotherapies, according to a study.
At the American Society of Retina Specialists meeting, Nathan C. Steinle, MD, of California Retina Consultants said patients who are treated with an anti-VEGF-A inhibitor often have an upregulation of VEGF-C and -D, “and it might represent ... why some of our patients don’t have full or optimal control with anti-VEGF-A alone.”
Previous research demonstrated visual acuity improvements in patients treated with a combination therapy of sozinibercept 2 mg and ranibizumab 0.5 mg, so Steinle and colleagues conducted a phase 1b study to investigate safety and durability of sozinibercept combination therapy through 6 months.
The study enrolled 40 patients split into three groups. The first group included nine patients with prior-treated diabetic macular edema who received a combination of sozinibercept (0.3 mg, 1 mg or 2 mg) and aflibercept 2 mg. The second group included 14 patients with treatment-naive neovascular age-related macular degeneration who received a combination of sozinibercept (0.3 mg, 1 mg or 2 mg) and ranibizumab 0.5 mg. The third group included 17 patients with prior-treated neovascular AMD who received a combination of sozinibercept (0.3 mg, 1 mg or 2 mg) and ranibizumab 0.5 mg. The study’s secondary endpoints included change in ETDRS best corrected visual acuity from baseline through week 24 as well as the mean time to and number of anti-VEGF-A re-treatment injections.
Before receiving the combination therapy, patients received an average of 6.6 anti-VEGF-A injections in the prior-treated DME group and 15.5 injections in the prior-treated neovascular AMD group.
After three initial loading doses, from week 8 through week 24 the mean number of injections was 0.4 for the prior-treated DME group, 1.4 for the treatment-naive neovascular AMD group and 1.9 for the prior-treated neovascular AMD group. Time to first supplemental injection for each group was 79.6 days, 60.4 days and 50.7 days, respectively, showing an overall reduction of treatment burden.
“The vision gained by these patients [was] maintained over that 4-month [as-needed] treatment interval,” Steinle said. “We also know [sozinibercept] has a very similar safety profile to what we’ve seen with our anti-VEGF therapies.”
The recently enrolled phase 3 COAST and ShORe trials will continue to investigate the efficacy and safety of sozinibercept in combination with aflibercept and ranibizumab, he said.
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Steinle NC. Durability of combination therapy of sozinibercept (OPT-302), an anti-VEGF-C/-D ‘trap’ with ranibizumab in nAMD or aflibercept in DME. Presented at: American Society of Retina Specialists annual meeting; July 17-20, 2024; Stockholm.
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