Sozinibercept Combination Therapy for Neovascular Age-related Macular Degeneration: Phase 2b Study Subgroup Analysis...

Area of Science:

• Ophthalmology
• Medical imaging
• Pharmacology

Background:

• Neovascular age-related macular degeneration (nAMD) poses a significant challenge in vision loss.
• Anti-vascular endothelial growth factor (anti-VEGF) therapies are standard treatments for nAMD.
• Identifying predictors of treatment response is crucial for optimizing patient outcomes.

Purpose of the Study:

• To evaluate angiographic predictors of response to sozinibercept, an anti-VEGF-C/-D agent.
• To assess the efficacy of sozinibercept in combination with ranibizumab for nAMD.

Main Methods:

• Phase 2b, randomized, double-masked, sham-controlled trial.
• 240 treatment-naïve nAMD participants received intravitreal sozinibercept (0.5 mg or 2 mg) plus ranibizumab, or ranibizumab monotherapy.
• Prespecified and post hoc subgroup analyses were conducted.

Main Results:

• Visual acuity benefits at week 24 were greatest in participants with occult lesions receiving 2 mg sozinibercept combination therapy (+15.65 letters vs. +9.62 letters with ranibizumab monotherapy).
• A composite analysis of occult and minimally classic lesions also favored sozinibercept over control (+16.08 vs. +10.34 letters).
• Structural outcomes, including reduced leakage and smaller lesions, mirrored visual acuity benefits.

Conclusions:

• Angiographic lesion characteristics predict response to sozinibercept combination therapy.
• Sozinibercept in combination with ranibizumab demonstrates potential for improved outcomes in specific nAMD patient subgroups.
• Further research into anti-VEGF-C/-D agents is warranted for nAMD treatment.