Patients on combination treatment with UBX1325 and aflibercept from weeks 24-48 maintained vision gains achieved at week 24 on aflibercept alone, with greater vision improvement in patients with more severe disease. Patients with prior anti-VEGF treatment and switched to UBX1325 monotherapy at study start maintained visual acuity through 24 weeks and had only a 1.5 letter decrease from baseline at week 48. 40% of UBX1325-treated patients did not require anti-VEGF treatment through 48 weeks and 64% achieved an anti-VEGF treatment-free interval of over 24 weeks. UBX1325 was well tolerated in both monotherapy and combination arms.
UBX1325 demonstrated a favorable safety and tolerability profile in the combination and monotherapy arms with no cases of significant intraocular inflammation, retinal artery occlusion or endophthalmitis. Patients switched from every 8-week aflibercept to a combination of aflibercept and UBX1325 at week 24 maintained vision gains achieved with aflibercept alone through week 48. Patients in a pre-specified subgroup with poor visual acuity at baseline (≤60 ETDRS letters) gained 3.2 ETDRS letters on combination treatment between weeks 24 and 48.
In the UBX1325 monotherapy arm, patients maintained visual acuity for the duration of the study, with a mean change of +0.1 ETDRS letters at the 24-week time point and a mean change of -1.5 ETDRS letters at 48 weeks. The median time to first anti-VEGF rescue was 32 weeks.
Additional 48-week data from the ENVISION study is expected to be presented at upcoming medical conferences. UNITY has initiated a Phase 2b study in patients with diabetic macular edema and expects to randomize the first patient in that study in Q4 2023.
About the ENVISION Study
The Phase 2 ENVISION study is a multi-center, randomized, double-masked, active-controlled study designed to evaluate the safety, tolerability, efficacy and durability of a repeat intravitreal injection of UBX1325 and aflibercept in patients with neovascular AMD evaluated through 48 weeks. The study enrolled 51 patients with an average baseline visual acuity of 60 ETDRS letters who had ongoing active disease with a baseline CST of approximately 370 µm and had been on anti-VEGF treatment for at least 6 months. All patients received a single run-in injection of aflibercept prior to the start of the study. Patients enrolled in the study were randomized into two arms: Patients in the UBX1325 monotherapy arm received an injection of UBX1325 at Week 0 and Week 4, and again at Week 24 and Week 28, for a total of four injections over the 48-week study. Patients in the control arm received an injection of aflibercept every 8 weeks through the duration of the full 48-week study. At Week 24 and Week 32, patients in the control arm received a combination of aflibercept with UBX1325, for a total of two doses of UBX1325 concurrent with their 8-week treatment interval.
