Clinical trial highlights benefits of pilocarpine eye drops for presbyopia

CSF-1, a 0.4% pilocarpine hydrochloride ophthalmic solution, significantly improves near vision in people with presbyopia without compromising distance vision and has a favorable safety profile, according to a study.

The Phase 3 clinical study evaluated the safety and effectiveness of CSF-1, a 0.4% pilocarpine hydrochloride ophthalmic solution, in 613 adults treated with CSF-1 or a vehicle twice daily over 2 weeks.

The primary endpoint, a ≥3-line improvement in near vision without significant loss of distance vision, was met by 40.1% of participants in the CSF-1 group compared to 19.1% in the vehicle group (P < 0.0001). Key secondary endpoints also showed significant improvements at all tested times.

Safety assessments revealed that most adverse events were mild and transient, with no severe or serious events reported. CSF-1 was well-tolerated and demonstrated a favorable safety profile.

Reference
Holland E, Karpecki P, Fingeret M, et al. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clin Ther. 2024;46(2):104-113. doi: 10.1016/j.clinthera.2023.12.005. Epub 2024 Jan 11. PMID: 38216351.