Following cataract surgery, a submicron formulation of loteprednol etabonate (LE) gel, 0.38% administered three times daily (TID), is safe and effective for treating ocular inflammation with minimal risk of intraocular pressure (IOP) elevation, according to study findings.
Following cataract surgery, a submicron formulation of loteprednol etabonate (LE) gel, 0.38% administered 3 times daily (TID), is safe and effective for treating ocular inflammation with minimal risk of intraocular pressure (IOP) elevation, according to study findings published in the journal Clinical Ophthalmology.
The research involved subjects of at least 18 years of age with anterior chamber (AC) cells of at least grade 2. After cataract surgery, the patients were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days.
“The use of topical corticosteroids following cataract surgery is routine for the management of postoperative inflammation and pain. Potential side effects of concern with the postsurgical use of ocular corticosteroids include increased IOP, susceptibility to infection, and delayed wound healing,” said the study authors. “Loteprednol etabonate (LE) is a retrometabolically designed topical corticosteroid that was engineered via modification of prednisolone in order to achieve the desired anti-inflammatory effect followed by rapid metabolism to inactive metabolites.”
Primary endpoints of the study were the proportion of subjects with resolution of AC cells and grade 0 (no pain) at postoperative day 8. As for safety endpoints, researchers measured for adverse events (AEs), ocular signs, fundoscopy results, visual acuity, IOP, and tolerability (drop comfort and ocular symptoms).
Of the 742 subjects examined, significantly more patients in the LE gel 0.38% TID group had complete resolution of AC cells and grade 0 pain at day 8 compared to the vehicle group. Additionally, the results revealed that LE gel was safe and well tolerated, with only 1 LE-treated subject experiencing an IOP elevation ≥10 mm Hg.
The results also suggested that treatment-related AEs were mild and occurred less frequently with LE gel 0.38% than with vehicle. More than 75% of subjects in each treatment group reported no drop discomfort, with no reports of blurred vision found in the LE gel study cohort.
“The results of this integrated analysis of 2 Phase 3 studies demonstrate that LE (submicron) gel 0.38% TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery with minimal risk of IOP elevation,” said the study authors.
Fong R, Cavet ME, DeCory HH, et al. Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies. [published online August 1, 2019]. Clin Ophthalmol. doi: 10.2147/OPTH.S210597.