Shots:

• The P-III (NEAR-1 & 2) trials evaluating CSF-1 vs PBO in a ratio (1:1) in 613 patients aged 45-64yrs. with presbyopia. The trial met its 1EPs & 2EPs i.e., patients achieved a ≥3-line gain in DCNVA & no loss of ≥1-line in distance VA
• In 2 studies, 40% & 50% of patients achieved gains @1hr. post-dose 1 & 2. The therapy also showed a 3-line improvement at all measured time points on Days 1 & 15, patients achieved ≥3-line improvement in DCNVA as early as 20min. on Day 15 & ~8hrs. post-dose 1
• The therapy showed good tolerability & safety profile with comparable redness & comfort validating preservative-free presentation & formulation of CSF-1. The company plans to submit the NDA to the US FDA in H2’22

Ref: PR Newswire | Image: Orasis