Shots:
- The P-II (ACUITY) study assessed safety, tolerability & efficacy of OCS-05 (2 or 3mg/kg/day, IV, QD) vs PBO for 5 days in acute optic neuritis patients (n=36), on steroid in EU. 33/36 received treatment and included in the pre-specified modified ITT analysis. Its IND is approved in the US to begin trial
- 1EP was achieved, showing 2 (OCS-05) vs 1 (PBO) patient (12.5% each) had normal to abnormal shift in ECG measure with mild, transient & clinically insignificant events by D15
- 2EPs assessed changes in retinal structure & visual function. At 3mos., OCS-05 (3mg/kg/day) improved GCIPL thickness by 43% (sustained at 6mos.), RNFL thickness by 28% (increased to 30% at 6mos.) plus LCVA mean change by ~18 (3mos.) & ~15 letters (6mos.)
Ref: Oculis | Image: Oculis
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