Orasis Pharmaceuticals Announces Positive Phase 3 Topline Results
In both trials, CSF-1 met its primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. Pooled across the two studies, 40% and 50% of participants demonstrated these gains 1-hour post-dose 1 and 1-hour post-dose 2 respectively (P<0.0001). CSF-1 also achieved statistically significant 3-line improvement at all measured time points on Days 1 and 15. On Day 15, participants achieved statistically significant 3-line or more improvement in DCNVA as early as 20 minutes and up to 8 hours post-dose 1. In addition, CSF-1 demonstrated an excellent tolerability and safety profile, with comparable redness and comfort versus vehicle, validating the preservative-free presentation and proprietary formulation of CSF-1. The most common treatment-related adverse events of headache and instillation sight pain occurred in only 6.8% and 5.8% of participants, respectively. Of all CSF-1 participants, only 2.6% reported moderate treatment-related adverse events. All other adverse events were mild.