Positive results from Opthea’s Phase 1b trial of sozinibercept combination therapy in diabetic macular oedema (DMO) have been published in the peer-reviewed journal Translational Vision Science & Technology (TVST).
DMO is the leading cause of central vision loss in people living with diabetes. It is estimated to affect around 19 million people worldwide, and with the rise of diabetes, the prevalence is expected to increase to 29 million by 2045. The disease occurs when blood vessels in the retina swell and leak, leading to fluid accumulation in the retina.
While anti-VEGF-A therapies are the current standard of care for DMO patients, there is an unmet need for early intervention to prevent irreversible damage of the retina. Additionally, there is a need to improve visual outcomes for patients treated with anti-VEGF-A therapies alone, which may lead to suboptimal vision outcomes.
These data… support the further investigation of sozinibercept as a treatment for DMO, a disease with rapidly increasing prevalence and unmet medical need
Opthea’s first-in-human, open-label, multicentre, dose escalating Phase 1b DMO trial evaluated the outcomes in previously anti-VEGF-A monotherapy treated patients with persistent DMO, a difficult-to-treat patient population.
Nine patients received sozinibercept (0.3, 1, or 2 mg) in combination with aflibercept (2 mg) once every four weeks for twelve weeks. The primary endpoint was safety, and the secondary endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and anatomical parameters, including central subfield thickness (CST). Sozinibercept combination therapy was well tolerated with no dose-limiting toxicities. The trial also demonstrated a dose-response relationship of increased gains in BCVA for ascending doses of sozinibercept, with the 2 mg sozinibercept combination arm demonstrating the highest BCVA gain. All sozinibercept doses demonstrated a meaningful CST reduction. These data, published in TVST, support the further investigation of sozinibercept as a treatment for DME, a disease with rapidly increasing prevalence and unmet medical need.
Frederic Guerard, Chief Executive Officer of Opthea, said the trial results “underpin sozinibercept’s potential as a novel, first-in-class VEGF-C/D ‘trap’ to elevate the standard of care in retinal diseases including DMO, by preventing blood vessel growth and vascular leakage in the retina and delivering improved visual and anatomic outcomes when combined with standard-of-care anti-VEGF-A therapies”.
Reference
Boyer DS, Steinle NC, Leitch IM et al, Phase 1b dose escalation study of sozinibercept inhibition of vascular endothelial growth factors C and D with aflibercept for diabetic macular edema. Trans. Vis. Sci. Tech. 2024;13(12):32. doi: 10.1167/tvst.13.12.32.
