September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Integrated Efficacy of Latanoprostene Bunod 0.024% vs. Timolol Maleate 0.5% for Intraocular Pressure Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension: APOLLO and LUNAR Studies
Author Affiliations & Notes
  • Paul L Kaufman
    Department of Ophthalmology & Visual Sciences, Univ of Wisconsin Sch of Med & Public Hlth, Madison, Wisconsin, United States
  • Jeffrey M Liebmann
    Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia University Medical Center, New York, New York, United States
  • Jason L Vittitow
    Clinical Affairs, Bausch + Lomb, Bridgewater, New Jersey, United States
  • Robert N Weinreb
    Hamilton Glaucoma Center, Shiley Eye Institute and Department of Ophthalmology, University of California, San Diego, La Jolla, California, United States
  • Footnotes
    Commercial Relationships   Paul Kaufman, Bausch & Lomb (C); Jeffrey Liebmann, Bausch + Lomb (C); Jason Vittitow, Bausch + Lomb (E); Robert Weinreb, Bausch + Lomb (C)
  • Footnotes
    Support  this study was sponsored by Bausch & Lomb
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3036. doi:
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      Paul L Kaufman, Jeffrey M Liebmann, Jason L Vittitow, Robert N Weinreb; Integrated Efficacy of Latanoprostene Bunod 0.024% vs. Timolol Maleate 0.5% for Intraocular Pressure Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension: APOLLO and LUNAR Studies. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3036.

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

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Purpose : Latanoprostene bunod (LBN) is a nitric oxide-donating prostaglandin F2α analogue in development for the reduction of IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). We report on the IOP-lowering effect of LBN ophthalmic solution 0.024% in subjects with OAG or OHT pooled across two randomized controlled clinical studies.

Methods : This was a pooled analysis of two phase 3, multicenter, double-masked, parallel-group, non-inferiority studies. In each study, subjects ≥18 years of age with OAG or OHT were randomized (2:1) to either LBN 0.024% qPM or timolol maleate 0.5% BID for 3 months. Subjects previously on IOP lowering medications completed a washout phase prior to randomization. IOP was measured at 8am, 12pm, and 4pm at 2 weeks, 6 weeks, and 3 months post-randomization (primary efficacy endpoint); differences between treatments were evaluated using an analysis of covariance. The proportions of subjects with IOP ≤18 mm Hg and IOP reduction ≥25% at all 9 time points were also compared. Adverse events (AEs) were recorded throughout each study.

Results : Of 831 subjects randomized, 774 (LBN 0.024%, n=523; timolol 0.5%, n=251) completed the 3 months of treatment across the two studies. Mean (SD) diurnal IOP (average of IOP at 8am, 12pm, and 4pm) at baseline was 26.7 (2.4) mm Hg in the LBN group and 26.5 (2.3) mm Hg in the timolol group. LBN-treated subjects had significantly greater reductions in mean IOP compared to timolol-treated subjects at each timepoint throughout the 3 month period (P<0.001). At the 3-month assessment time point, the reduction from baseline in diurnal IOP was 8.6 (3.0) mm Hg with LBN and 7.3 (2.9) mm Hg with timolol treatment (P<0.001). Of LBN- and timolol-treated subjects, 20.2% vs. 11.2% (P=0.001) had their IOP reduced ≥25% from baseline and 32.9% vs. 19.0%, (P<0.001) had their IOP reduced to ≤18 mm Hg over all time points. Ocular AEs were infrequent, although slightly higher with LBN, and mostly mild-moderate in severity.

Conclusions : Results from this pooled analysis of two randomized controlled studies demonstrate that LBN 0.024% instilled qPM was significantly more effective in reducing IOP than timolol 0.5% instilled BID in patients with OAG or OHT over the 3-month treatment period.

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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