The submicron-sized drug particles in loteprednol etabonate gel 0.38% have a median diameter of about 0.6 μm. By comparison, loteprednol etabonate gel 0.5% contains micronized drug particles that are about 3 μm in diameter.
Even though the new submicron formulation contains a lower concentration of loteprednol etabonate, it is effective with just twice-daily dosing because of its better drug dissolution and drug penetration characteristics compared with the 0.5% gel formulation, Dr. McDonald said.
The efficacy and safety of submicron loteprednol etabonate gel 0.38% for the treatment of postoperative inflammation and pain was investigated in a double-masked, vehicle-controlled randomized study that included 514 patients undergoing cataract surgery [Fong R, et al. J Cataract Refract Surg. 2018;44:1220-1229].
The proportions of patients with 1) resolution of anterior chamber cells and 2) no pain on postoperative day 8 were assessed as the primary outcome measures. Statistically significant differences favoring the BID and TID submicron loteprednol etabonate groups compared with vehicle were found in the analyses of both anterior chamber cell resolution (26.9% and 28.7% versus 9.3%) and absence of pain (73.7% and 73.1% versus 47.7%).
No safety concerns emerged in the submicron loteprednol etabonate treatment groups, and the treatment was well-tolerated.
Marguerite B. McDonald, MD
E: [email protected]
Dr. McDonald is a consultant to Bausch + Lomb and other companies that market topical anti-inflammatory medications.