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D.H. McGee, J.D. Heaton, M.M. Gruebbel, R.B. Hackett, R.L. Rice, J.W. Hiddemen; Ocular Effects of Nepafenac Ophthalmic Suspension in New Zealand White Rabbits Undergoing Partial Corneal Incisions . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2648.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To determine the ocular effects of Nepafenac Ophthalmic Suspension dosed prior to and for one month following partial corneal incision in New Zealand white rabbits. Methods: Four groups of 8 rabbits each were randomly assigned to receive either 0%, 0.1%, 0.3%, or 1.0% Nepafenac Ophthalmic Suspension (preserved with 0.01% BAK). Treatment with 2 drops (total 80 microliters) 4 times a day in the right eye began 7 days before the partial thickness corneal incision and continued for 34 days. The left eye served as an untreated control. After 7 days of dosing, a 3 to 5 mm incision to a depth of 60% of the corneal thickness was made parallel to the limbus. A fifth group of 8 rabbits (sham control group) received a corneal incision, but no topical treatment. Slit–lamp examination was performed at baseline and on Days 5, 9, 14, 20, 29, and 34. Indirect ophthalmoscopy was conducted at baseline and after approximately 1 month of treatment. Pachymetry was performed at baseline and on Days 7, 15, and 28. On Day 35, ocular tissues and adnexa were obtained for histological examination. Results: Biomicroscopy revealed mild to moderate conjunctival hyperemia and transient, sporadic minimal conjunctival discharge with Nepafenac and Vehicle following the incision period. In every case, the discharge resolved by the next examination. Fluorescein staining showed complete reepithelialization following incision with no differences among groups. Indirect ophthalmoscopy revealed no fundus abnormalities in any group. No statistical differences in central corneal thickness occurred between Nepafenac–treated, vehicle–treated, and untreated control eyes. At necropsy, no gross abnormalities were observed in the ocular tissues. Microscopic evaluation of ocular tissues revealed minimal to mild corneal epithelial hyperplasia at the incision site consistent with regeneration after corneal incision in all operated eyes of the Nepafenac, Vehicle, and sham groups. Conclusions: Four–times–daily topical ocular dosing with Nepafenac Ophthalmic Suspension, 0.1%, 0.3%, or 1.0% did not induce ocular irritation or toxicity, or delay corneal wound healing when administered for 7 days prior to and continued for 27 days following a partial thickness corneal incision.
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