Opthea Limited (ASX: OPT) has announced the publication of its Phase 1b trial of sozinibercept combination therapy in diabetic macular edema (DME) in the peer-reviewed journal Translational Vision Science & Technology (TVST).
The publication evaluated the outcomes in previously anti-VEGF-A monotherapy treated patients with persistent DME, a difficult-to-treat patient population.
The article was also included in the Anti-VEGF Special Journal Issue of TVST, the official Journal of The Association for Research in Vision and Ophthalmology (ARVO).
“The DME 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 DME, 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,” said Frederic Guerard, PharmD, Opthea’s CEO.
“Whilst our immediate focus is to prepare for the anticipated sozinibercept Phase 3 topline data readout in wet AMD of COAST in early CY Q2 2025 and ShORe in mid-2025, we also plan to advance our clinical development program of sozinibercept in DME.”
In this first-in-human, open-label, multicentre, dose escalating Phase 1b DME trial, nine patients received sozinibercept in combination with aflibercept once every four weeks for 12 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.
Diabetic macular edema 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. DME occurs when blood vessels in the retina swell and leak, leading to fluid accumulation in the retina.
Anti-VEGF-A therapies are the current standard of care for DME patients. There is an unmet need for early intervention to prevent irreversible damage of the retina, as well as improve visual outcomes for patients treated with anti-VEGF-A therapies alone, which may lead to suboptimal vision outcomes.