Review Finds Lotemax SM Safe to Use After Ocular Surgery

Bausch & Lomb’s loteprednol etabonate ophthalmic gel 0.38% (Lotemax SM) was found to have no meaningful impact on intraocular pressure (IOP) or visual acuity when administered to patients post surgery, according to a review¹ published in Clinical Drug Investigation. The gel formulation was approved by the FDA in 2019 to treat postoperative inflammation and pain following ocular surgery.

In contrast to loteprednol etabonate micronized gel 0.5% (Lotemax Gel), loteprednol etabonate ophthalmic gel 0.38% comprises drug particles in the submicron range, which improves dissolution and penetration into ocular tissues. Thus, using less loteprednol etabonate can still achieve significant therapeutic effects in patients.

Researchers analyzed 2 multicenter randomized phase 3 trials and found “significantly more loteprednol etabonate gel 0.38% recipients than vehicle recipients displayed complete resolution of ocular inflammation and ocular pain at day 8 post cataract surgery.”

In addition, total resolution of pain was achieved as early as 3 days after surgery. Adverse events, including 1 incidence each of photophobia, cystoid macular oedema, eyelid oedema, and instillation site pain, occurred in less than 1% of subjects who received loteprednol etabonate gel 0.38%.

Due to the promising results, the researchers concluded “loteprednol etabonate gel 0.38% extends the treatment options available in resolving postoperative inflammation and pain in patients who have undergone ocular surgery.”

A separate study² published in 2019 investigated in vitro dissolution profiles of loteprednol etabonate (submicron) gel 0.38% and that of micronized loteprednol etabonate gel 0.38%, 0.5%, and 0.75% in a fixed volume of dissolution media. Researchers found the “smaller loteprednol etabonate particle size of the submicron formulation (ie, 0.6 μm) was associated with an increased rate of dissolution versus the 3-micronized drug particle concentrations.”

However, on March 18, 2020, the American Academy of Ophthalmology (AAO) urged all ophthalmologists to cease providing treatments apart from urgent or emergent care, in response to the coronavirus disease 2019 (COVID-19) pandemic.

According to the academy, decisions on reopening eye clinics to routine care and resuming elective eye surgery will need to be made based on numerous factors, including evolving city and state restrictions on nonessential services, local/regional new case rates, availability of personal protective equiptment, and access to COVID-19 testing.

Updated interim guidelines on resuming elective ophthalmic care and recommended protocols when scheduling or seeing patients were released on May 6. “Until there is reliable point-of-care testing, an FDA-approved and highly effective therapy, and/or an approved and effective vaccine, practices and clinics should continue to mandate social distancing in waiting rooms, frequent and meticulous disinfection of patient waiting and care areas, and the wearing of face coverings by both patients and caregivers,” the AAO website reads.

References

1. Kang C, Keam SJ, Shirley M, Syed YY. Loteprednol etabonate (submicron) ophthalmic gel 0.38%: a review in post-operative inflammation and pain following ocular surgery. Clin Drug Investig. 2020;40(4):387-394. doi:10.1007/s40261-020-00899-2

2. Cavet ME, Glogowski S, Lowe ER, Phillips E. Rheological properties, dissolution kinetics, and ocular pharmacokinetics of loteprednol etabonate (submicron) ophthalmic gel 0.38%. J Ocul Pharmacol Ther. 2019;35(5):291-300. doi:10.1089/jop.2018.0136