September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Efficacy of Latanoprostene Bunod 0.024% vs. Timolol Maleate 0.5% for Intraocular Pressure Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension: the LUNAR Study
Author Affiliations & Notes
  • James H Peace
    United Medical Research Institute, Inglewood, California, United States
  • Felipe A Medeiros
    Hamilton Glaucoma Center, Shiley Eye Institute, University of California, San Diego, La Jolla, California, United States
  • Keith R Martin
    Eye Department, Addenbrooke's Hospital and Cambridge NIHR Biomedical Research Centre, Cambridge, United Kingdom
  • 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   James Peace, Bausch + Lomb (C); Felipe Medeiros, Bausch + Lomb (C); Keith Martin, 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, 3035. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      James H Peace, Felipe A Medeiros, Keith R Martin, Jason L Vittitow, Robert N Weinreb; Efficacy of Latanoprostene Bunod 0.024% vs. Timolol Maleate 0.5% for Intraocular Pressure Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension: the LUNAR Study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3035.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : Studies have shown that every mm Hg reduction in intraocular pressure (IOP) is associated with a decreased risk in the onset or progression of glaucoma. Latanoprostene bunod (LBN), a nitric oxide-donating prostaglandin F2α analogue, is in development for the reduction of IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). We evaluated the IOP-lowering effect of LBN ophthalmic solution 0.024% compared with timolol maleate ophthalmic solution 0.5% in a randomized controlled trial of subjects with OAG or OHT.

Methods : This was a phase 3, multicenter, double-masked, parallel-group, non-inferiority study. Subjects ≥18 years of age with OAG or OHT were randomized (2:1) to LBN instilled qPM or timolol instilled BID for 3 months. Intraocular pressure was measured at 8am, 12pm, and 4pm at 2 weeks, 6 weeks, and 3 months post-randomization (9 time points; primary efficacy endpoint); differences between treatments in mean IOP were evaluated using an analysis of covariance. Secondary efficacy endpoints included the proportion of subjects with IOP ≤18 mm Hg and IOP reduction ≥25% at all 9 time points. Adverse events (AEs) were recorded throughout the study.

Results : A total of 387 subjects (LBN 0.024%, n=259; timolol 0.5%, n=128) completed 3 months of double-masked treatment. LBN treatment led to significantly greater reductions in mean IOP compared to timolol (P≤0.025) at all but one time point (Week 2, 8 am). The mean reduction from baseline in mean diurnal IOP (average of IOP at 8am, 12pm, and 4pm) was significantly greater with LBN than with timolol at all study visits (-8.0 vs. -7.3, -8.4 vs. -7.5, and -8.4 vs. -7.3 mm Hg at week 2, 6, and month 3, respectively; P≤0.034). Of LBN- and timolol-treated subjects, 31.0% vs. 18.5% (P=0.007) had their IOP reduced ≥25% from baseline and 17.7% vs. 11.1%, (P=0.084) had their IOP reduced to ≤18 mm Hg at all 9 time points. Ocular treatment-emergent AEs were mild to moderate in severity and infrequent, though higher with LBN; all were mild to moderate in severity with one exception (conjunctival hyperemia in the LBN group).

Conclusions : Results from this randomized controlled trial demonstrate that LBN 0.024% instilled qPM was effective at reducing IOP in patients with OAG or OHT over a 3 month period with a favorable safety profile.

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

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×