UNITY Biotechnology, Inc. announced that the key safety and efficacy endpoints were met at 24 weeks in the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). The Company intends to initiate a pivotal study in DME in the second half of 2023. At 24 weeks after a single dose of UBX1325, the mean change in BCVA of UBX1325-treated subjects was an increase of +6.2 ETDRS letters, representing an improvement of +7.6 ETDRS letters compared to sham-treated subjects from baseline (p = 0.0084).

In addition, patients treated with UBX1325 maintained CST compared to sham-treated patients who demonstrated worsening of CST (i.e., increased retinal thickness) through 24 weeks. Of patients treated with UBX1325, 59.4% did not require anti-VEGF standard of care through 6 months, as compared to only 37.5% of sham-treated patients. Patients enrolled in BEHOLD had been on anti-VEGF treatment for at least 6 months prior to enrollment into the study (mean injection frequency of 4 in the preceding 6 months), with the last anti-VEGF injection occurring 3 – 6 weeks prior to randomization.

Patients enrolled in BEHOLD had been on anti-VEGF treatment for at least 6 months prior to enrollment into the study (mean injection frequency of 4 in the preceding 6 months), with the last anti-VEGF injection occurring 3 – 6 weeks prior to randomization.