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– Two presentations on the Phase 2b clinical trial show CSF-1 met the primary endpoints and achieved statistically significant and clinically meaningful improvements in distance-corrected near visual acuity (DCNVA) for participants with presbyopia
– Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process and affects more than 120 million people in the US
PONTE VEDRAFla. , April 23, 2022 /PRNewswire/ — Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced Phase 2b data demonstrating the efficacy and safety of its novel eye drop candidate, CSF-1, for the treatment of presbyopia at the 2022 American Society for Cataract and Refractive Surgery (ASCRS) Annual Meeting being held April 22-26 in Washington, DC The Phase 2b Trial served as the foundation for the design and conduct of the Phase 3 NEAR-1 and NEAR-2 clinical trials of CSF-1, for which topline results were recently announced.
In the first Paper Session, which will be presented on Monday, April 25the Phase 2b trial results showed that CSF-1 (pilocarpine hydrochloride 0.4%) preservative-free ophthalmic solution formulated in a proprietary vehicle met its primary endpoint, with 47% of participants in the CSF-1 group achieving a 3-line or more gain in DCNVA 1 -hour post-treatment on Day 15 compared to 16% in the vehicle group (P=0.0002). Additionally, the trial met its secondary endpoint, with 80% of participants in the CSF-1 group achieving a 2-line or more gain in DCNVA compared to 43% in the vehicle group (P=0.0001). CSF-1 demonstrated tolerability with a favorable safety profile. The most reported treatment-related adverse events experienced by …
Full story available on Benzinga.com
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