September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Long-term Efficacy and Safety of Latanoprostene Bunod 0.024% for Intraocular Pressure Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension: APOLLO and LUNAR Studies
Author Affiliations & Notes
  • Jason L Vittitow
    Clinical Affairs, Bausch + Lomb, Bridgewater, New Jersey, United States
  • Jeffrey M Liebmann
    Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia University Medical Center, New York, New York, United States
  • Paul L Kaufman
    Department of Ophthalmology & Visual Sciences, Univ of Wisconsin Sch of Med & Public Hlth, Madison, Wisconsin, 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
  • 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   Jason Vittitow, Bausch + Lomb (E); Jeffrey Liebmann, Bausch + Lomb (C); Paul Kaufman, Bausch + Lomb (C); Felipe Medeiros, Bausch + Lomb (C); Keith Martin, Bausch + Lomb (C); Robert Weinreb, Bausch + Lomb (C)
  • Footnotes
    Support  this study was sponsored by Bausch & Lomb
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 3030. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      Jason L Vittitow, Jeffrey M Liebmann, Paul L Kaufman, Felipe A Medeiros, Keith R Martin, Robert N Weinreb; Long-term Efficacy and Safety of Latanoprostene Bunod 0.024% for Intraocular Pressure Lowering in Patients with Open-Angle Glaucoma or Ocular Hypertension: APOLLO and LUNAR Studies. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3030.

      Download citation file:


      © 2017 Association for Research in Vision and Ophthalmology.

      ×
  • Supplements
Abstract

Purpose : Latanoprostene bunod (LBN), a nitric oxide-donating prostaglandin F2α analogue, is in development for the reduction of intraocular pressure (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 the open label safety extension phase of two randomized controlled clinical trials and on the safety of LBN in these studies.

Methods : APOLLO and LUNAR were phase 3, multicenter, double-masked, parallel-group, non-inferiority trials. In each study, subjects ≥18 years of age with OAG or OHT were randomized (2:1) to double-masked treatment of either LBN instilled qPM or timolol instilled BID for 3 months; thereafter all subjects instilled LBN qPM open-label for an additional 9 (APOLLO) or 3 (LUNAR) months. IOP was measured at 8am, 12pm, and 4pm at all visits including baseline, week 2, week 6, month 3, month 6 (APOLLO and LUNAR), and month 9 and 12 (APOLLO only). We report mean diurnal IOP (average of IOP at 8am, 12pm, and 4pm) at follow-up visits pooled across these studies during the safety extension phase. Safety assessments included vital signs, comprehensive ophthalmic exams and treatment emergent adverse events (TEAEs).

Results : Of 811 subjects in the pooled data set that entered the open-label safety extension phase, 737 subjects completed the extension phase. Subjects randomized to timolol who then switched to LBN in the safety extension phase demonstrated an additional 6.3 to 8.3% decrease in mean diurnal IOP. Reductions from baseline in diurnal IOP ranged from 32-34% for all subjects (P<0.001 vs baseline) throughout the extension phase (Table). Overall, 18.7% of subjects on LBN treatment experienced ocular TEAEs (study eye); the most common of these were conjunctival hyperemia (5.9%), eye irritation (4.6%), eye pain (3.5 %). The majority (>99.5%) of ocular TEAEs were mild-moderate in severity, and there were no safety concerns based on ocular signs, BCVA, and vital signs, or endothelial cell stress with LBN based on specular microscopy.

Conclusions : Pooled results from the open-label extension phase of the APOLLO and LUNAR studies demonstrate that IOP lowering with LBN instilled qPM was maintained through 12 months with no loss of IOP lowering effect. LBN demonstrated 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.

×