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