A phase 2b clinical trial of sozinibercept, an investigational treatment for neovascular age-related macular degeneration (nAMD), demonstrated statistically significant improvements in visual acuity when used in combination with ranibizumab, according to data published in Ophthalmic Surgery, Lasers and Imaging (OSLI) Retina.

The randomized, controlled trial included 366 treatment-naïve nAMD patients. At 24 weeks, patients receiving sozinibercept 2 mg in combination with ranibizumab showed a statistically significant mean gain of 5.7 letters in best-corrected visual acuity (BCVA) compared to ranibizumab alone. The subgroup analysis indicated that patients with occult and minimally classic lesions, excluding those with retinal angiomatous proliferation (RAP), experienced greater improvements in vision, with a higher proportion gaining 15 or more letters. Anatomical benefits included better drying of the retina and reduced choroidal neovascularization (CNV) area.

Secondary outcomes supported the efficacy of the combination therapy, with more patients gaining 10 or more letters and experiencing reductions in swelling and vascular leakage. The treatment demonstrated a favorable safety profile.

Opthea Limited, the developer of sozinibercept, is conducting two concurrent phase 3 trials, COAST and ShORe, to evaluate the therapy’s safety and efficacy in combination with aflibercept and ranibizumab, respectively. These trials aim to support regulatory approval for sozinibercept’s use with any anti-VEGF-A therapy. The US Food and Drug Administration has granted the treatment Fast Track Designation for nAMD. RP