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Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema

Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed t...

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Autores principales: Navarro-Partida, Jose, Altamirano-Vallejo, Juan Carlos, Gonzalez-De la Rosa, Alejandro, Armendariz-Borunda, Juan, Castro-Castaneda, Carlos Rodrigo, Santos, Arturo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7998140/
https://www.ncbi.nlm.nih.gov/pubmed/33801366
http://dx.doi.org/10.3390/pharmaceutics13030322
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author Navarro-Partida, Jose
Altamirano-Vallejo, Juan Carlos
Gonzalez-De la Rosa, Alejandro
Armendariz-Borunda, Juan
Castro-Castaneda, Carlos Rodrigo
Santos, Arturo
author_facet Navarro-Partida, Jose
Altamirano-Vallejo, Juan Carlos
Gonzalez-De la Rosa, Alejandro
Armendariz-Borunda, Juan
Castro-Castaneda, Carlos Rodrigo
Santos, Arturo
author_sort Navarro-Partida, Jose
collection PubMed
description Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards.
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spelling pubmed-79981402021-03-28 Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema Navarro-Partida, Jose Altamirano-Vallejo, Juan Carlos Gonzalez-De la Rosa, Alejandro Armendariz-Borunda, Juan Castro-Castaneda, Carlos Rodrigo Santos, Arturo Pharmaceutics Article Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards. MDPI 2021-03-02 /pmc/articles/PMC7998140/ /pubmed/33801366 http://dx.doi.org/10.3390/pharmaceutics13030322 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ).
spellingShingle Article
Navarro-Partida, Jose
Altamirano-Vallejo, Juan Carlos
Gonzalez-De la Rosa, Alejandro
Armendariz-Borunda, Juan
Castro-Castaneda, Carlos Rodrigo
Santos, Arturo
Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema
title Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema
title_full Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema
title_fullStr Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema
title_full_unstemmed Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema
title_short Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema
title_sort safety and tolerability of topical ophthalmic triamcinolone acetonide-loaded liposomes formulation and evaluation of its biologic activity in patients with diabetic macular edema
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7998140/
https://www.ncbi.nlm.nih.gov/pubmed/33801366
http://dx.doi.org/10.3390/pharmaceutics13030322
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