Opthea Reports Positive Phase 1b DME Trial Results
MELBOURNE, Australia and PRINCETON, N.J. - Opthea Limited (ASX/NASDAQ: OPT), a biopharmaceutical company focused on developing treatments for retinal diseases, has published the results of its Phase 1b trial of sozinibercept for diabetic macular edema (DME) in the peer-reviewed journal Translational Vision Science & Technology. The study evaluated the safety and efficacy of sozinibercept combined with the standard-of-care anti-VEGF-A therapy, aflibercept, in patients with persistent DME.
The trial, which was the first to involve human subjects, included nine patients who received varying doses of sozinibercept in combination with aflibercept over a twelve-week period. The primary goal was to assess safety, while secondary endpoints focused on visual acuity and anatomical changes in the retina.
According to the company's press release, the sozinibercept combination therapy was well tolerated and showed no dose-limiting toxicities. A dose-response relationship was observed, with the highest dose of sozinibercept yielding the most significant gains in best-corrected visual acuity (BCVA). All doses resulted in a meaningful reduction in central subfield thickness (CST), an important measure of DME severity.
These findings suggest that sozinibercept could represent a novel approach to DME treatment by targeting VEGF-C and VEGF-D, which are implicated in blood vessel growth and leakage in the retina. DME is a major cause of vision loss in individuals with diabetes and is expected to affect an increasing number of people as the global prevalence of diabetes rises.
Opthea plans to advance the clinical development of sozinibercept in DME, following the anticipated release of Phase 3 topline data for wet age-related macular degeneration (wet AMD) from the COAST and ShORe trials later in 2025.
In other recent news, Opthea Limited has announced the appointment of Kathy Connell to its Board of Directors, a move that coincides with the company's preparation for Phase 3 wet AMD topline data expected in 2025. Connell's role is deemed crucial as Opthea approaches significant regulatory and commercial milestones. Simultaneously, Opthea has successfully completed its drug substance Process Performance Qualification campaign for sozinibercept, a potential treatment for wet age-related macular degeneration.
In leadership changes, Daniel Geffken has been appointed as the interim Chief Financial Officer and Mike Campbell as the new Chief Commercial Officer. These changes are in preparation for the anticipated launch of sozinibercept in 2025. Analyst firm H.C. Wainwright has revised its price target for Opthea, lowering it to $12.00 while maintaining a Buy rating, and Oppenheimer raised the company’s price target from $16 to $18, maintaining an Outperform rating.