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A. Okumura, M. Tsuzuki, T. Wada, T. Kida, T. Tajika, H. Sakaki, A. Ohtori; Efficacy of Difluprednate Ophthalmic Emulsion in Preclinical Studies of Uveitis. Invest. Ophthalmol. Vis. Sci. 2007;48(13):2652.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the inhibitory effect of difluprednate ophthalmic emulsion (DFBA) on uveitis in three animal models.
The inhibitory effect of DFBA at the 0.002%, 0.01% and 0.05% doses was compared to that of betamethasone (BM) 0.1% on uveitis in animal models; experimental melanin-protein-induced uveitis in rats (EMIU), bovine serum albumin-induced uveitis in rabbits (BIU) and endotoxin-induced uveitis in rats (EIU). In the study of EMIU, after melanin protein was injected into the footpad of rats to induce uveitis, test drugs were administered 4 times a day and ocular symptoms were observed for 20 days. In the study of BIU, bovine serum albumin was injected into the vitreous body of rabbits. Drug administration and ocular observation were carried out in the same way as EMIU. In the study of EIU, test drugs were administered immediately after induction of inflammation, and at 4 h and 8 h post induction. 24 h after induction, aqueous humor was collected to measure the concentration of protein.
EMIU: The effect of DFBA was concentration dependent, and significant inhibitory effects were noted in the eyes treated with the 0.01% and 0.05% doses compared to the eyes that received saline. The peak value of inflammation symptoms were significantly suppressed in the eyes instilled with BM compared to that of eyes that received saline. Efficacy of DFBA was comparable to that of BM, and DFBA 0.05% significantly inhibited the uveitis. BIU: All concentrations of DFBA inhibited the inflammation in a dose-dependent manner, and the inhibitory effect was significant compared to that of saline. BM also showed significant inhibitory effect compared to saline. Compared to BM, DFBA 0.05% had a significantly higher inhibitory effect. EIU: The concentration of protein in the aqueous humor in the control group was 26.26 mg/mL, whereas the protein in the groups that received DFBA 0% (vehicle), 0.002%, 0.01%, or 0.05% were 24.62, 26.26, 14.56, and 7.55 mg/mL, respectively, indicating that the inhibitory effect of DFBA is dose dependent. The inhibitory effect of DFBA was statistically significant in concentrations ≥ 0.01%. In the group that received BM, the protein concentration was 14.92 mg/mL. When compared to BM 0.1%, the inhibitory effect of DFBA 0.05% was statistically superior.
DFBA inhibited uveitis in animal models in a dose-dependent manner, and the 0.05% dose showed higher anti-inflammatory activity compared to BM 0.1%.
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