Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema
Autor: | Arturo Santos, Juan C. Altamirano-Vallejo, Jose Navarro-Partida, Carlos Rodrigo Castro-Castaneda, Juan Armendáriz-Borunda, Alejandro González-de la Rosa |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
Intraocular pressure
medicine.medical_specialty Triamcinolone acetonide Visual acuity genetic structures medicine.drug_class Pharmaceutical Science lcsh:RS1-441 030226 pharmacology & pharmacy Article safety and tolerability lcsh:Pharmacy and materia medica 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine ocular drug delivery system Ophthalmology Medicine Adverse effect business.industry allergology biologic activity Retinal eye diseases Posterior segment of eyeball posterior segment of the eye Tolerability chemistry 030221 ophthalmology & optometry Corticosteroid sense organs medicine.symptom business topical liposomes diabetic macular edema medicine.drug |
Zdroj: | Pharmaceutics Pharmaceutics, Vol 13, Iss 322, p 322 (2021) Volume 13 Issue 3 |
ISSN: | 1999-4923 |
Popis: | 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. |
Databáze: | OpenAIRE |
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