September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Impact of the topical ophthalmic corticosteroid loteprednol etabonate on intraocular pressure
Author Affiliations & Notes
  • Megan E Cavet
    Medical Affairs, Bausch & Lomb, Rochester, New York, United States
  • Heleen H DeCory
    Medical Affairs, Bausch & Lomb, Rochester, New York, United States
  • John D Sheppard
    Department of Ophthalmology, Eastern Virginia Medical School, Norfolk, Virginia, United States
  • Footnotes
    Commercial Relationships   Megan Cavet, Bausch + Lomb (E); Heleen DeCory, Bausch + Lomb (E); John Sheppard, Bausch + Lomb (R), Bausch + Lomb (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 5405. doi:
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      Megan E Cavet, Heleen H DeCory, John D Sheppard; Impact of the topical ophthalmic corticosteroid loteprednol etabonate on intraocular pressure. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5405.

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

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Purpose : Topical ophthalmic corticosteroid use is associated with side effects such as intraocular pressure (IOP) elevation. Loteprednol etabonate (LE) contains a C-20 ester group which causes it to undergo rapid metabolism following glucocorticoid receptor activation and therefore has a lower risk of causing side effects. Here we report on the overall incidence of clinically significant (≥10 mm Hg) IOP elevations across multiple clinical studies with the use of LE.

Methods : Clinical studies evaluating the use of LE for any indication that reported data on the incidence of clinically significant IOP elevations (defined as ≥10 mm Hg) with the use of LE were included in this analysis. Incidence rates of IOP elevation arising from short-term (<28 days) or long-term (≥28 days) administration of LE were calculated through summation of IOP data from respective studies and compared to that for vehicle, and the active controls prednisolone acetate (PA) and dexamethasone in conjunction with tobramycin (DM/T). Those subjects known to be wearing contact lenses during treatment were excluded from the analysis.

Results : A total of 31 studies (12 short-term and 19 long-term) reported on IOP elevations ≥10 mm Hg when LE was used in the treatment of various ocular surface and intraocular inflammatory disorders, including ocular allergy, DED, anterior uveitis, corneal transplantation, and postoperative pain and inflammation. The overall incidence of IOP elevation ≥10 mm Hg was 0.8% (14/1725 subjects) for short-term use and 1.5% (21/1386 subjects) for long-term use. The cumulative incidence of IOP elevation ≥10 mm Hg was similar to vehicle (0.6% [9/1407] vs. 0.4% [6/1365]; P=0.65) but significantly lower than that for patients treated with PA (3.4% [10/291] vs. 11.3% [33/292]; P<0.001) or DM/T (1.8% [9/491] vs. 5.2% [25/485]; P=0.008).

Conclusions : Topical ocular treatment with LE had minimal effect on IOP when used in the treatment of a wide range of inflammatory conditions, including those requiring long-term use. The incidence of IOP elevation with LE appears lower than for the ophthalmic steroids PA and DM.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.


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