Preclinical safety and acute toxicity of a sterile anti-allergic ophthalmic solution (PRO-118) prepared by Laboratorios Sophia, SA de CV, applied on the ocular surface in healthy New Zealand rabbits

Poster Details

First Author: Y.Contreras MEXICO

Co Author(s):    L. Baiza Dur   B. P   C. Ramos Castell   G. Flores Te   L. Urquides Espinoza   A. Rodr

Abstract Details

Purpose:

Allergic conjunctivitis, is a chronic and debilitating condition from the ocular surface. It seems to be related with at least one immediate hypersensitivity reaction, called anaphylactic reaction. An antigen (allergen) reacts with IgE (or IgG) antibodies attached to mast cells or circulating basophiles occurring a release of pharmacological mediators. PRO-118 is a new active, highly potent and selective anti-allergic with a fast action. To evaluate clinical and histopathological safety and acute toxicity of a new anti-allergic ophthalmic solution (PRO-118) when applied on the ocular surface in New Zealand rabbits.

Setting:

Laboratorios Sophia, SA de CV Paseo del Norte No. 5255 Guadalajara Technology Park Carretera Guadalajara-Nogales Km. 13.5 Zip code 45010 Jalisco, México +52 (33) 30014283

Methods:

Sixteen rabbits were numbered; one group, received PRO-118 solution on their right eye and placebo on the left eye; other group, received PRO-118 solution on their left eye and placebo on the right eye. The applications were scheduled every two hours from 7 to 19 hrs, for 15 days. Clinical assessment was accomplished on days 0, 1, 2, 4, 7, 10 and 15. Safety parameters taken into account were: conjunctival hyperemia, chemosis, corneal surface integrity, conjunctival secretion, Rose Bengal and fluorescein staining. On days 0 and 15, fundoscopy was performed under pharmacological mydriasis. Day 16, all rabbits where euthanized and performed enucleation. A masked histopathological study was executed: cornea (looking for changes in the epithelial thickness, basal membrane integrity, cellular changes), conjunctiva (looking for globet cells, apoptosis, lack of keratinization).

Results:

Thirty-two eyes were assessed, 16 were treated with PRO-118 solution and the remaining 16 were treated with placebo. In both groups such clinical and histopathological had not showed toxicity data

Conclusions:

The ophthalmic solution PRO-118 is clinically and histopathologically safe when applied to the ocular surface of New Zealand rabbits. FINANCIAL DISCLOSURE?: No