In Vitro Toxicity Evaluation of New Generic Latanost® and Latacom® as an Ophthalmic Formulation

Abstract

A bstract Aim and objective To evaluate the safety of two new generic ophthalmic formulations, Latanost ® (latanoprost) and Latacom ® (latanoprost and timolol) by utilizing the three-dimensional reconstructed human cornea-like epithelium (RhCE) tissue constructs as an in vitro model in the assessment of ocular irritation. Materials and methods In vitro irritation test was conducted on Latanost ® (LTN) and Latacom ® (LTC) and their corresponding innovators, Xalatan ® (XLT) and Xalacom ® (XLC), respectively, by using RhCE. According to the OECD guidelines No. 492 on the testing of chemicals, the ophthalmic formulations were assessed via topical exposure of the formulations on in vitro RhCE tissue. Cell viability was measured by MTT assay. Results The mean cell viability percentage of LTN and XLT was 70.5 and 75.7%, respectively, whereas, for LTC and XLC, the percentage viability was 95.3 and 85.7%, respectively. The two new generic formulations (LTN and LTC) did not reduce the cell viability of the RhCE tissue to ≤60%. Thus, both can be considered as nonirritant. Conclusion Both newly developed generics are nonocular irritants. Clinical significance This study informs the safety assessment of new generic antiglaucoma ophthalmic solutions applicable for long-term glaucoma treatment. The formulations aim to keep eye irritation to a minimum level. How to cite this article Ng JSC, Tan YX, Alwi NAA, et al. In Vitro Toxicity Evaluation of New Generic Latanost ® and Latacom ® as an Ophthalmic Formulation. J Curr Glaucoma Pract 2021;15(3):139–143.

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“…101 Choosing non-irritating surfactants and excipients, conducting comprehensive preclinical studies minimizing vision effects, selecting hypoallergenic materials, conducting skin patch testing, monitoring intraocular pressure, excluding individuals with known glaucoma, ensuring contact lens compatibility, maintaining tear film stability minimizing photophobia, providing clear instructions, reporting unusual side effects and adhering to safety guidelines are all important factors. 102…”