Opthea's progress in wet AMD treatment

Opthea Limited (ASX: $OPT) has completed the enrollment for its Phase 3 trials for sozinibercept, a potential treatment for wet age-related macular degeneration (wet AMD). The company anticipates topline data from both pivotal Phase 3 studies in mid-CY2025.

Executive commentary on sozinibercept

Sozinibercept, a VEGF-C/D TRAP, has demonstrated strong clinical evidence of superior patient visual outcomes. The Phase 2b trial showed a +5.7 letter gain over standard of care, addressing the high unmet need in wet AMD treatment. The Phase 3 trials, COAST and ShORe, are well advanced, and the primary analysis is optimized for success, focusing on high-responding patient populations.

Summary of Opthea's wet AMD treatment progress

Opthea's sozinibercept has the potential to be the first product in over 15 years to improve visual outcomes for wet AMD patients. The completion of Phase 3 enrollment and the anticipation of topline data in mid-CY2025 mark significant milestones in Opthea's efforts to address the unmet medical need in wet AMD treatment. The company's strategic outlook includes advancing clinical milestones, manufacturing scale-up, regulatory preparations, and commercial readiness, positioning sozinibercept as a differentiated combination approach targeting better visual outcomes and driving commercial value.