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Article

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

1
Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Campus Guadalajara, P.C. 45138 Zapopan, Mexico
2
Centro de Retina Medica y Quirurgica, S.C., Centro Medico Puerta de Hierro, P.C. 45116 Zapopan, Mexico
3
Instituto de Biología Molecular y Terapia Genica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, P.C. 44340 Guadalajara, Mexico
*
Author to whom correspondence should be addressed.
Academic Editor: Carla M. Lopes
Pharmaceutics 2021, 13(3), 322; https://doi.org/10.3390/pharmaceutics13030322
Received: 23 January 2021 / Revised: 22 February 2021 / Accepted: 24 February 2021 / Published: 2 March 2021
(This article belongs to the Special Issue Overcoming Physiological Barriers Using Lipid Nanosystems)
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. View Full-Text
Keywords: ocular drug delivery system; topical liposomes; posterior segment of the eye; safety and tolerability; biologic activity; diabetic macular edema ocular drug delivery system; topical liposomes; posterior segment of the eye; safety and tolerability; biologic activity; diabetic macular edema
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MDPI and ACS Style

Navarro-Partida, J.; Altamirano-Vallejo, J.C.; Gonzalez-De la Rosa, A.; Armendariz-Borunda, J.; Castro-Castaneda, C.R.; Santos, A. Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema. Pharmaceutics 2021, 13, 322. https://doi.org/10.3390/pharmaceutics13030322

AMA Style

Navarro-Partida J, Altamirano-Vallejo JC, Gonzalez-De la Rosa A, Armendariz-Borunda J, Castro-Castaneda CR, Santos A. Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema. Pharmaceutics. 2021; 13(3):322. https://doi.org/10.3390/pharmaceutics13030322

Chicago/Turabian Style

Navarro-Partida, Jose, Juan C. Altamirano-Vallejo, Alejandro Gonzalez-De la Rosa, Juan Armendariz-Borunda, Carlos R. Castro-Castaneda, and Arturo Santos. 2021. "Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema" Pharmaceutics 13, no. 3: 322. https://doi.org/10.3390/pharmaceutics13030322

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