California, USA-based UNITY Biotechnology (Nasdaq: UBX] has announced top-line results from the Phase IIb ASPIRE clinical trial of intravitreal UBX1325 (foselutoclax) in patients with diabetic macular edema (DME) who had poor vision despite prior anti-VEGF treatment.
The study results include data from all patients through 24 weeks, and the majority of patients through 36 weeks. UBX1325 treatment led to visual acuity gains of over 5 letters from baseline at weeks 24 and 36, and achieved non-inferiority to aflibercept at 9 out of 10 time points through 36 weeks, except for the average of weeks 20 and 24, where it achieved non-inferiority at an 88% confidence interval (compared to a 90% threshold pre-specified as primary analysis endpoint).
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