July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
Proportion of subjects achieving zero-trace anterior chamber inflammation with loteprednol etabonate (submicron) gel 0.38% following cataract surgery: Integrated analysis of 3 pivotal trials
Author Affiliations & Notes
  • Joseph Martel
    California Northstate University, Elk Grove, California, United States
    Martel Eye Medical Group, Rancho Cordova, California, United States
  • Raymond Fong
    Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, New York, United States
  • Megan E Cavet
    Bausch + Lomb, Rochester, New York, United States
  • Jason Vittitow
    Bausch + Lomb, Bridgewater, New Jersey, United States
  • Footnotes
    Commercial Relationships   Joseph Martel, Bausch + Lomb (F); Raymond Fong, Bausch + Lomb (F); Megan Cavet, Bausch + Lomb (E); Jason Vittitow, Bausch + Lomb (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 251. doi:
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      Joseph Martel, Raymond Fong, Megan E Cavet, Jason Vittitow; Proportion of subjects achieving zero-trace anterior chamber inflammation with loteprednol etabonate (submicron) gel 0.38% following cataract surgery: Integrated analysis of 3 pivotal trials. Invest. Ophthalmol. Vis. Sci. 2019;60(9):251.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Loteprednol etabonate (LE) ophthalmic gel 0.5% is indicated for the treatment of postsurgical inflammation and pain with QID dosing. A new formulation of LE gel with smaller drug particles (0.4-0.6 µm vs. 3-5 µm), lower drug concentration (0.38%), and reduced dosing frequency was evaluated for the treatment of pain and inflammation following cataract surgery. Primary efficacy outcomes were previously presented. Here, we report results for the proportion of subjects achieving 0-to-trace anterior chamber inflammation (ACI) integrated across three pivotal studies.

Methods : Data from three Phase 3 multicenter, randomized, double-masked clinical studies were available, two of which evaluated both TID and BID dosing and one which evaluated BID dosing only. In each study, subjects with an AC score ≥Grade 2 following cataract surgery received LE (submicron) gel 0.38% or vehicle for 14 days, and AC cells and flare (both graded on a 0-4 scale) were assessed on postoperative days 3, 8, and 15. Data for the proportion of patients with 0-to-trace ACI (≤5 AC cells and none-to-mild flare; <Grade 2 on a 0-8 scale), adverse events, intraocular pressure (IOP), and ocular signs were integrated across studies.

Results : At days 3, 8, and 15, respectively, the proportions of subjects achieving 0-to-trace ACI were significantly greater in the in the LE (submicron) gel 0.38% TID and BID groups vs. vehicle (30.2% vs. 20.5%, 57.7% vs. 27.0% and 70.4% vs. 38.3% for LE gel TID [n=371] vs. vehicle [n=371] and 32.7% vs. 22.1%, 56.6% vs. 31.3% and 67.1% vs. 44.0 for LE gel BID [n=535] vs. vehicle [n=534]; P<0.003 for all vs. respective vehicle group). Ocular adverse events were infrequent and mostly mild in severity. Three subjects experienced an intraocular pressure elevation ≥10 mm Hg during treatment with LE (submicron) gel 0.38%. Other safety findings were unremarkable. The majority (>76%) of patients in either LE treatment group reported no discomfort upon instillation across the three studies.

Conclusions : LE (submicron) gel 0.38% dosed either BID or TID appeared safe, well-tolerated, and effective in reducing ACI following cataract surgery in this integrated analysis of three pivotal Phase 3 studies.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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