CSF-1 eye drops show promise in treating presbyopia
Data presented at ASCRS 2023 suggests that CSF-1 (0.4% pilocarpine HCl ophthalmic solution) could be an effective treatment for presbyopia.
The Phase 3 clinical trials, NEAR-1 and NEAR-2, which evaluated the safety and efficacy of CSF-1 in treating presbyopia, enrolled 613 participants between the ages of 45-64 years old with distance-corrected near visual acuity (DCNVA) logMAR scores between ≥0.40 and ≤0.90. Participants were randomly assigned to receive either CSF-1 (n = 309) or vehicle (n = 304) and were instructed to apply 1 drop of the solution twice daily for 2 weeks.
The proportion of participants who achieved a gain of at least 2 lines in DCNVA without a loss of ≥1 in corrected distance visual acuity (CDVA) was significantly higher in the CSF-1 group than the vehicle group at all tested time points. Improvement was observed as early as 20 minutes post-dose 1, with 63.1% of the CSF-1 group achieving the 2-line gain compared to 43.4% of the vehicle group. The improvement was maintained up to 8 hours on day 15.
Furthermore, the post-hoc analysis found that the proportion of participants who achieved 20/40 DCNVA or better was also significantly higher in the CSF-1 group than the vehicle group at all time points. Achieving a 2-line gain resulted in DCNVA of 20/40 or better in most early to moderate presbyopes.
The study also found that CSF-1 was well-tolerated, with most adverse events classified as mild and self-resolving. No severe adverse events were reported.
Gupta PK, et al. Near-1 and Near-2 Clinical Trials: Clinically Meaningful Near Vision Improvement with CSF-1 (0.4% Pilocarpine HCl) Treatment for Presbyopia. Presented at: ASCRS 2023.
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