Top-line results from the phase 2b ASPIRE trial demonstrate that the investigational drug UBX1325 (Unity Biotechnology) produced visual acuity gains comparable to aflibercept 2 mg (Eylea; Regeneron) in patients with diabetic macular edema (DME) who had prior poor responses to anti-VEGF treatment. The company plans to release complete 36-week data in the second quarter of 2025, according to a press release.

UBX1325 is a potent small molecule inhibitor of BCL-xL, a protein that senescent cells rely on for survival. ASPIRE is a prospective, multicenter study designed to evaluate the efficacy and safety of UBX1325 in 52 patients with active DME despite prior treatment. Patients were randomized to receive UBX1325 10 µg or aflibercept 2 mg every 8 weeks for a follow-up period of 36 weeks.

According to the top-line data, UBX1325-treated patients gained an average of +5.2 Early Treatment Diabetic Retinopathy Scale (ETDRS) letters in best-corrected visual acuity (BCVA) at 24 weeks and +5.5 letters at 36 weeks. The drug met the trial’s noninferiority criteria at 24 weeks, with more than 90% confidence, though it did not reach statistical noninferiority for the average of weeks 20 and 24, achieving an 88% confidence interval. Unity Biotechnology reported that UBX1325 was numerically superior to aflibercept in 7 out of 10 time points in patients with moderately aggressive disease.