Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 23 January 2021 / Approved: 25 January 2021 / Online: 25 January 2021 (10:48:51 CET)

A peer-reviewed article of this Preprint also exists.

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. 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.

Journal reference: Pharmaceutics 2021, 13, 322
DOI: 10.3390/pharmaceutics13030322

Abstract

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 in the ocular surface. To evaluate the safety, tolerability, and biologic activity of TALF, an animal study and a phase I clinical assay was performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biologic activity of the formulation. No inflammation, lens opacity, swelling or intraocular pressure rising were recorded after the instillation of TALF in any of the animal or clinical study. Mainly, mild and transient adverse events such as dry eye (30%) and burning (30%) were reported. TALF improves significantly visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biologic 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 corticosteroids IVTs and its associated hazards.

Keywords

ocular drug delivery system; topical liposomes; posterior segment of the eye; safety and toler-ability; biologic activity; diabetic macular edema

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