Diabetic macular edema treatment promising at 24 weeks in phase 2 study
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UBX1325 met safety and efficacy endpoints at 24 weeks in the phase 2 BEHOLD study in patients with diabetic macular edema, according to a press release from Unity Biotechnology.
After a single injection of the investigational compound, subjects experienced an increase in best corrected visual acuity of 6.2 ETDRS letters at 24 weeks, which represented an improvement of 7.6 ETDRS letters over sham-treated subjects from baseline (P = .0084).
Subjects in the treatment arm also maintained central subfield thickness, while those in the sham arm demonstrated a worsening of central subfield thickness. In the treatment arm, 59.4% of subjects did not require anti-VEGF standard of care through 6 months compared with 37.5% of those in the sham arm.
The safety and tolerability profile was favorable, and no subjects experienced intraocular inflammation, retinal artery occlusion, endophthalmitis or vasculitis.
“Based on the results of this study, we believe UBX1325 could lead to significant vision gain while reducing treatment burden for patients,” Anirvan Ghosh, PhD, CEO of Unity, said in the release. “The durable effect we’ve now observed through 6 months following just a single injection of UBX1325 suggests it could represent a longer-lasting, disease-modifying treatment option for patients.”
Unity expects 48-week safety and efficacy data from the study in the second quarter of 2023.