Regenxbio Presents Results of RGX-314 in P-II ALTITUDE Trial for the Treatment of Diabetic Retinopathy at ASRS Annual Meeting

October 11, 2021 Auto Bot Clinical Trials, Diabetic Retinopathy, P-II, Regenxbio 0

Shots:

  • The ongoing P-II ALTITUDE trial evaluates the efficacy, safety & tolerability of RGX-314 (29.5×1011 GC/eye & 5×1011 GC/eye in cohorts 1 & 2) using SCS microinjection vs observational control in a ratio (3:1) in 20 patients (cohort 1 & 2) with DR without CI-DME
  • As of Sept 29, 2021, RGX-314 was well tolerated in 15 patients in cohort 1 out of which 5 patients (33%) demonstrated a ≥2 step improvement from baseline on ETDRS-DRSS @3mos. & 1 patient had a 4-step improvement
  • Additionally, 7 & 8 patients who had NPDR & PDR at baseline, 3 patients (43%) & 2 patients (25%) demonstrated a ≥2 step improvement @3mos. while cohort 2 & 3 continue to enroll patients at 5×1011 GC/eye dose

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