Key points from article :
UNITY Biotechnology has announced topline results from its Phase 2b ASPIRE study, evaluating UBX1325 in patients with diabetic macular edema (DME) who had poor vision despite previous anti-VEGF treatments. The study, published by UNITY Biotechnology and led by CEO Anirvan Ghosh, PhD, assessed UBX1325 against aflibercept, a standard treatment for DME. The trial found that UBX1325 provided sustained vision improvements, with patients gaining over five letters in visual acuity from baseline at 24 and 36 weeks. The drug was largely non-inferior to aflibercept across multiple time points, except for a brief period at weeks 20 and 24.
DME affects around 1.7 million people in the U.S., with nearly half of those treated experiencing suboptimal responses to existing anti-VEGF therapies. UNITY's investigational drug, UBX1325, takes a novel approach by targeting senescent cells in the retina using a BCL-xL inhibitor. The trial results suggest that patients with moderate disease severity and those switching from aflibercept saw the most consistent and durable vision improvements.
UBX1325 demonstrated a strong safety profile, with no cases of severe eye inflammation or occlusions reported. Experts, including Dr. David S. Boyer of the Keck School of Medicine at USC, highlight the drug’s potential to break the cycle of ineffective anti-VEGF treatments for many patients. UNITY plans to release complete 36-week data in 2025 and advance UBX1325 to late-stage trials, aiming to offer a promising alternative for those with limited treatment options.
