February 2016: Regenera releases Interim Results from its Phase 2 study in patients with previous NAION.11/02/16
RPh201 was subsequently administered SC twice each week for 6 months and was well tolerated. Administration site reactions were the most frequently reported treatment-emergent adverse events (TEAE). After 26 weeks of treatment, 6 (100%) of the 6 eyes in the RPh201- treated group achieved an improvement of >2 lines of vision, compared to 2 (50%) of 4 eyes in the placebo group. RPh201-treated subjects improved best-corrected visual acuity (BCVA) by 7 lines from baseline vs 4 lines in the placebo.
The interim clinical study results have shown positive results, and, as was expected by the Company due to the small number of patients, these results are not statistically significant. The trial is ongoing and full results are expected by June 2016.