Opthea (ASX:OPT), a clinical-stage biopharmaceutical company, is advancing the development of Sozinibercept, a new treatment for wet age-related macular degeneration (AMD). The company is conducting two pivotal Phase 3 trials, COAST and ShORe, to evaluate the efficacy and safety of this treatment, with results expected by 2025. Opthea aims to address unmet medical needs and target a global market valued at approximately $15 billion.
Opthea is strategically advancing its product, Sozinibercept, through pivotal Phase 3 trials to establish its efficacy and safety as a treatment for wet AMD. The trials aim to support a broad label for use with any VEGF-A inhibitors, potentially revolutionizing the treatment landscape. The company is poised to tap into a substantial market, with the potential to create a new multi-billion dollar class addressing the high unmet need for better visual outcomes. With a Development Funding Agreement ensuring non-dilutive funding and a strategy for potential commercialization, Opthea is set to make significant strides in the biopharmaceutical industry. The FDA's Fast Track designation facilitates a streamlined path to market, underscoring Opthea's commitment to innovation and patient care.
Sozinibercept could be the first product in 20 years to significantly improve visual outcomes in wet AMD patients when used in combination with existing anti-VEGF-A therapies. The therapy has shown promise in Phase 2b trials, demonstrating superior visual gains over standard treatments.