Unity Touts Positive Data From Diabetic Macular Edema Study, Plans Head-To-Head Study With Regeneron's Eylea

  • UNITY Biotechnology Inc UBX announced results from the long-term follow-up of the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME).
  • Patients taking UBX1325 saw a mean change in best-corrected visual acuity of +6.2 ETDRS letters from baseline, a statistically significant result (p=0.0037). 
  • At 48 weeks, Unity also noted a difference of +5.6 ETDRS letters compared to sham-treated patients, but that part of the result was not statistically significant (p=0.1198).
  • Also Read: UNITY Biotechnology's Wet AMD Candidate Flunks On Non-Inferiority Threshold Compared To Regeneron's Drug.
  • In addition, patients treated with UBX1325 maintained stable CST compared to worsening in sham-treated patients.
  • Additionally, around 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.
  • The company added that there are no reports of intraocular inflammation, retinal artery occlusion, endophthalmitis, or vasculitis on the safety front.
  • Unity plans to launch a Phase 2b head-to-head study of UBX1325 against Regeneron Pharmaceutical Inc's REGN Eylea (aflibercept) in diabetic macular edema in the second half of 2023.
  • Price Action: UBX shares are up 9.52% at $2.09 on the last check Monday.
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