Opthea Limited announced the publication of sozinibercept Phase 2b data in Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina.
The paper entitled “Sozinibercept Combination Therapy for Neovascular Age-Related Macular Degeneration: Phase 2b Study Subgroup Analysis by Lesion Type” reports pre-specified and post-hoc analyses of angiographic predictors of response to sozinibercept combination therapy with ranibizumab in treatment-naïve patients with wet AMD, the company said in a press release. The analyses are based on choroidal neovascularization (CNV) type lesions (occult, minimally classic, and predominantly classic), and the presence and absence of retinal angiomatous proliferation (RAP) on visual acuity and anatomical outcomes. The data were derived from the randomized, controlled phase 2b trial in which sozinibercept 2 mg combination therapy led to superior visual gains compared to ranibizumab monotherapy at
24 weeks.
The phase 2b pre-specified analyses of subgroups showed that in patients with occult and minimally classic lesions excluding RAP, which represented 73% of the Phase 2b total patient population, sozinibercept combination therapy demonstrated a statistically significant additional 5.7-letter mean gain in best-corrected visual acuity (BCVA) compared to ranibizumab alone. A greater proportion of patients in this subgroup also gained ≥15 letters and had improved anatomy of better drying of the retina with reduced CNV area at week 24 compared to ranibizumab alone.
In addition, the company said its pivotal phase 3 wet AMD program is comprised of 2 fully enrolled, concurrent, multicenter, double-masked, randomized clinical trials, COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab). The trials are designed to assess the safety and superior efficacy of sozinibercept combination therapy vs standard-of-care anti-VEGF-A in wet AMD. The phase 3 program is designed to support a broad label and, if successful, enable sozinibercept to be approved for use in combination with any anti-VEGF-A therapy in wet AMD patients. Sozinibercept has received Fast Track Designation from the US Food and Drug Administration (FDA) for the treatment of wet AMD. To learn more about Opthea’s phase 3 clinical trial program, visit ClinicalTrials.gov for COAST, NCT04757636, and ShORe, NCT04757610.
In Opthea’s prospective, randomized and controlled Phase 2b trial, including 366 treatment-naïve wet AMD patients, sozinibercept was administered in combination with standard-of-care ranibizumab for the treatment of wet AMD. Sozinibercept combination therapy met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive with the combination therapy, including more patients gaining vision of 10 or more EDTRS letters, with improved anatomy, a reduction in swelling and vascular leakage, and a favorable safety profile. These statistically significant results were published in Ophthalmology in February 2023.