UNITY Biotechnology, Inc. announced positive results from the long-term follow-up of the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). A single injection of UBX1325 treatment led to a statistically significant improvement in vision lasting for the duration of the study (48 weeks), marked by a gain of +6.2 ETDRS letters from baseline, representing a difference of +5.6 ETDRS letters compared to sham-treated patients. In addition, patients treated with UBX1325 maintained stable CST compared to worsening in sham-treated patients.

The BEHOLD study enrolled patients who, despite being on anti-VEGF treatment for at least 6 months, displayed persistent visual acuity deficits and residual retinal fluid. At baseline, patients in the study had an average visual acuity of 61.4 ETDRS letters and a CST of approximately 439.6 microns. In the 6 months prior to study enrollment, patients received an average of 4 anti-VEGF injections, with the last anti-VEGF injection occurring 3-6 weeks prior to randomization.

Fifty patients completed the 48-week study extension. 48-Week Phase 2 BEHOLD Data: UBX1325 demonstrated a favorable safety and tolerability profile with no cases of intraocular inflammation, retinal artery occlusion, endophthalmitis, or vasculitis. Patients treated with UBX1325 had a mean change in BCVA of +6.2 ETDRS letters from baseline to 48 weeks (p=0.0037), representing a difference of +5.6 ETDRS letters compared to sham-treated patients (p=0.1198).

Based on an analysis of the BCVA change from baseline to last observation before anti-VEGF rescue or end of study participation, UBX1325 showed a +7.6 ETDRS letter advantage over sham (p = 0.0007). Approximately 53% of UBX1325-treated patients went 48 weeks without requiring any anti-VEGF rescue treatment compared to only 22% of patients in the sham arm. Patients treated with UBX1325 had a mean change in CST of -16.6 microns from baseline at 40 weeks, representing an improvement compared to sham of -56.3 microns (p = 0.0479); at 48 weeks, UBX1325 had a mean change of -13.7 microns representing an improvement of -37.9 microns compared to sham (p = NS, in part due to the low number of sham patients remaining rescue-free at 48 weeks).