Clinical-stage biopharmaceutical company Opthea (ASX:OPT) has completed the final week 52 patient visit in COAST, the first of two Phase 3 pivotal trials investigating the superiority and safety of sozinibercept in combination with aflibercept (COAST) or ranibizumab (ShORe), compared to standard of care alone for the treatment of wet AMD.
The topline results from both trials are anticipated in early Q2 CY25 (COAST) and mid-CY25 (ShORe).
“The completion of the final week 52 patient visit in COAST is an important milestone in the development of sozinibercept, as we deliver on our mission of improving visual outcomes in patients with wet AMD to enable fuller and healthier lives,” said Frederic Guerard, PharmD, CEO of Opthea.
“I would like to thank Charles Wykoff, MD, PhD as well as all of the COAST investigators and their clinical staff for their excellent work as we plan to announce the anticipated topline data in early Q2 CY25.”
Opthea is conducting two concurrent global pivotal Phase 3 clinical trials for the treatment of wet AMD, aiming to demonstrate superiority of sozinibercept combination therapy versus standard of care alone: COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT- 302 in combination with Ranibizumab).
The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy. Beyond week 52, patients will continue to be treated for an additional year to evaluate extended safety and tolerability up to a two-year period.
Opthea’s 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 FDA for the treatment of wet AMD.
Opthea’s lead product candidate in Phase 3 development, sozinibercept, is a first-in-class VEGF- C/D ‘trap’ inhibitor being evaluated in combination with standard-of-care anti-VEGF-A therapies to deliver superior vision to wet AMD patients. Sozinibercept has the potential to become the first therapy in 20 years to enable patients with wet AMD live fuller and healthier lives.
