Abstract
Purpose :
Use of topical corticosteroids (CSs) to treat ocular inflammation may be limited by CS class-associated adverse events (AEs) including intraocular pressure (IOP) increase, glaucoma, cataracts, delayed healing, and infections. Loteprednol etabonate (LE) is a topical ophthalmic CS which undergoes rapid metabolism following exertion of its anti-inflammatory effect and therefore has a low propensity for eliciting AEs. A next generation LE formulation (LE SM gel 0.38%) with reduced (submicron-sized) drug particles and improved ocular penetration was introduced in early 2019. We report on occurrence of ocular CS class-associated AEs for this and other LE ophthalmic formulations.
Methods :
The Bausch + Lomb pharmacovigilance (PV) AE database system (ARISGlobal®) was queried for all CS class-associated AEs (spontaneous, study, literature) reported in the US for LE ophthalmic formulations since development and launch of the first LE suspensions in the late 1990s through September 2020. The following formulations were included in the analysis: LE 0.5% and 0.2% suspensions, LE 0.5% and tobramycin 0.3% suspension, LE 0.5% ointment, LE 0.5% gel, and LE SM 0.38% gel. Throughout the reporting period, AEs were entered into the PV database using preferred MedDRA terms.
Results :
Corticosteroid-associated AEs for LE SM 0.38% gel were infrequent, with 8 reports of IOP increase, 2 reports of cataract, and 1 reported eye infection. Across all LE formulations, there were a total of 19 reports of cataract, 131 reports of IOP increase, 19 reports of glaucoma or ocular hypertension, 8 reports of impaired healing, and 56 reports of ocular infections. Most AEs were categorized as non-serious, with the exception of several reports of glaucoma and cataract. During this reporting period, nearly 67 million units were shipped for these products in the US.
Conclusions :
Corticosteroid class-associated AEs were reported infrequently in the PV AE database for all LE formulations, including for the recently introduced LE SM 0.38% gel formulation, suggestive of a very low incidence rate for these AEs with LE treatment. Data limitations include possible underreporting of AEs due to the voluntary nature of the reporting and uncertainty as to whether the AE was causally related to LE treatment.
This is a 2021 ARVO Annual Meeting abstract.