Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival and retarded development in the offspring during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period.
In the injection group, mean IOP decreased from ± mmHg (baseline) to ± mmHg at 1 week (p = ). The topical group had a stable IOP at 1 week ( ± mmHg) compared to baseline ( ± mmHg; p = ). At 1 month, mean IOP was ± mmHg (p = ) in the injection group and ± mmHg (p = ) in the topical group. The intragroup changes were neither statistically significant nor clinically relevant at any postoperative visit. Both groups had the highest values of intraocular inflammation at the 1-week postoperative visit, followed by a decline to barely traceable levels at 1 month. The difference was not clinically relevant at any postoperative visit.