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 model in the assessment of ocular irritation.
Materials And Methods: 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 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, Toxicity Evaluation of New Generic Latanost and Latacom as an Ophthalmic Formulation. J Curr Glaucoma Pract 2021;15(3):139-143.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8807938 | PMC |
| http://dx.doi.org/10.5005/jp-journals-10078-1319 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Preliminary Study on an Alternative Test Method with MCTT HCE for Ocular Irritation Test of Ophthalmic Medical Devices.
Toxics
March 2023
Korea Conformity Laboratories, 8, Gaetbeol-ro 145 Beon-gil, Yeonsu-gu, Incheon 21999, Republic of Korea.
Article Synopsis
- The market growth for ophthalmic medical devices is pushing the need for alternatives to animal testing for eye irritation assessments, leading to a call for novel in vitro testing methods.
- Researchers evaluated a human corneal model using common contact lens materials (HEMA and PMMA) and various chemicals, following established OECD and GHS guidelines.
- Results from three certified labs showed the new method demonstrated strong reproducibility and predictive accuracy, suggesting it is suitable for testing eye irritation linked to ophthalmic devices.
The user safety assessment of a selenized yeast feed additive.
Cutan Ocul Toxicol
September 2022
Regulatory Department, Alltech SARL, Rue Charles Amand, Vire, France.
Of the several selenized yeasts authorised for use as feed additives in the EU, CNCM I-3060 inactivated' (Sel-Plex), was the first to be approved for use, in 2006. The additive has a concentration of selenium between 2000 and 2400 mg/kg and a selenomethionine content greater than 63%. Previous toxicological and safety studies have shown Sel-Plex to be safe for use for target animal species, consumers, users and the environment.
View Article and Find Full Text PDFIn-house performance assessment of 3D QobuR-Reconstructed Human Cornea-Like Epithelium (RhCE) for the evaluation of eye hazard.
Toxicol In Vitro
August 2022
Instituto Universitario Fernández-Vega, Fundación de Investigación Oftalmológica, Universidad de Oviedo, Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain; Centro de Investigación Biomédica en Red en Enfermedades Raras (CIBERER) (U714), ISCIII, Madrid, Spain.
To replace the Draize eye irritation test (OECD Test Guideline 404), several test methods based on reconstructed cornea-like epithelium (RhCE) have been developed and adopted in the OECD TG 492. The objective of this study was to stablish the experimental procedures and evaluate the performance assessment of QobuR-RhCE, an in-house RhCE model to be used for the evaluation of eye hazard. We define the essential structural, functional and procedural elements of the test method components to help assuring that the proposed test method is based on the same concepts as the validated reference methods.
View Article and Find Full Text PDFImpedance-based non-invasive assay for ocular damage prediction on in vitro 3D reconstructed human corneal epithelium.
Bioelectrochemistry
August 2022
Instituto Universitario Fernández-Vega, Fundación de Investigación Oftalmológica, Universidad de Oviedo, Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain; Departamento de Medicina (Farmacología), Universidad de Oviedo, Oviedo, Spain; Centro de Investigación Biomédica en Red en Enfermedades Raras (CIBERER) (U714), ISCII, Madrid, Spain.
Reconstructed human cornea-like epithelium (RhCE) holds unprecedented promise for toxicological analyses and the replacement of animal use. However, current standards to evaluate potential ocular irritancy present a major downfall, the need to invasively alter tissue samples to evaluate cell viability. In this study, the applicability of impedance analysis was validated by monitoring the change in cell capacitance during tissue maturation and before and after chemical application using coupled electrodes.
View Article and Find Full Text PDFToxicity Evaluation of New Generic Latanost and Latacom as an Ophthalmic Formulation.
J Curr Glaucoma Pract
January 2021
Formulation R&D Technologies, Duopharma Innovation Sdn. Bhd., Shah Alam, Selangor, Malaysia.
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 model in the assessment of ocular irritation.
Materials And Methods: 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.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!