Phase 2b study highlights effectiveness of pilocarpine in treating presbyopia

A recent Phase 2b clinical trial demonstrated that 0.4% pilocarpine HCl (CSF-1), either alone or in combination with diclofenac sodium, significantly improves near vision in individuals with presbyopia.

The randomized, double-masked study included 166 adults aged 45-64 treated with either pilocarpine HCl alone, a fixed-dose combination (FDC) of pilocarpine HCl with diclofenac sodium, or diclofenac sodium only (control group).

By day 15, 43.1% of participants in the FDC group and 46.9% in the CSF-1 group achieved a ≥3-line improvement in mesopic, monocular, distance-corrected near visual acuity at 40 cm. In contrast, only 16.1% of the control group reached this milestone. Statistical significance was observed for both the FDC and pilocarpine-only groups compared to control (P = 0.0015 and P = 0.0002, respectively).

The trial also showed that 0.2% pilocarpine, used earlier in the study, had no significant benefit compared to the control. All formulations were well tolerated.

Reference
Farid M, Rowen SL, Moshirfar M, et al. Combination Low-Dose Pilocarpine/Diclofenac Sodium and Pilocarpine Alone for Presbyopia: Results of a Randomized Phase 2b Clinical Trial. Clin Ophthalmol. 2024;18:3425-3439. doi: 10.2147/OPTH.S476658. PMID: 39606177; PMCID: PMC11600938.