[Pubmed] Safety and effect of topical neostigmine ophthalmic solution in animal models

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Sci Rep. 2025 Aug 22;15(1):30847. doi: 10.1038/s41598-025-16328-3.

ABSTRACT

The study aimed to evaluate the safety and effect of various dosages of topical neostigmine ophthalmic solution (TNOS) in animal models and establish a recommended dosage for further studies on myasthenia gravis (MG) diagnosis. A placebo-controlled, sequential ascending dose study was conducted in healthy rabbits. Eighteen eyes were randomized to receive one of three concentrations (1.0, 1.5, and 2.5 mg/mL) of TNOS. Pupillary sizes over time were compared with control group that received normal saline solution (NSS). Mean pupillary size of the 1.5 mg/mL group was significantly smaller than control at 30 to 180 min after instillation (maximal mean difference (TNOS - NSS); mMD - 2.58, 95% confidence interval (95% CI) -4.24 to -0.93, p = 0.006). The mean pupillary size of the 2.5 mg/mL group was significantly smaller than the control at 60 to 90 min (mMD - 3.13, 95% CI -5.07 to -1.18, p = 0.005). No significant difference in pupillary size between 1.5 and 2.5 mg/mL groups was observed at any time points. No systemic or ocular complications were observed in any concentration. The 1.5 mg/mL TNOS was the lowest efficacious dose in this study without adverse effects and was considered a promising starting dose for further MG studies.

PMID:40847050 | DOI:10.1038/s41598-025-16328-3


Source: https://pubmed.ncbi.nlm.nih.gov/4084705 ... t9+e462414