Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension The APOLLO Study

Purpose: To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) ophthalmic solution 0.024% every evening (qPM) with timolol maleate 0.5% twice daily (BID) in subjects with openangle glaucoma (OAG) or ocular hypertension (OHT). Design: Phase 3, randomized, controlled, multicenter, double-masked, parallel-group clinical study. Participants: Subjects aged >= 18 years with a diagnosis of OAG or OHT in 1 or both eyes. Methods: Subjects were randomized (2:1) to a 3-month regimen of LBN 0.024% qPM or timolol 0.5% 1 drop BID. Intraocular pressure was measured at 8 AM, 12 PM, and 4 PM of each postrandomization visit (week 2, week 6, and month 3). Adverse events were recorded throughout the study. Main Outcome Measures: The primary efficacy end point was IOP in the study eye measured at each of the 9 assessment time points. Secondary efficacy end points included the proportion of subjects with IOP <= 18 mmHg consistently at all 9 time points and the proportion of subjects with IOP reduction >= 25% consistently at all 9 time points. Results: Of 420 subjects randomized, 387 completed the study (LBN 0.024%, n = 264; timolol 0.5%, n = 123). At all 9 time points, the mean IOP in the study eye was significantly lower in the LBN 0.024% group than in the timolol 0.5% group (P <= 0.002). At all 9 time points, the percentage of subjects with mean IOP <= 18 mmHg and the percentage with IOP reduction >= 25% were significantly higher in the LBN 0.024% group versus the timolol 0.5% group (mean IOP <= 18 mmHg: 22.9% vs. 11.3%, P = 0.005; IOP reduction >= 25%: 34.9% vs. 19.5%, P = 0.001). Adverse events were similar in both treatment groups. Conclusions: In this phase 3 study, LBN 0.024% qPM demonstrated significantly greater IOP lowering than timolol 0.5% BID throughout the day over 3 months of treatment. Latanoprostene bunod 0.024% was effective and safe in these adults with OAG or OHT. (C) 2016 by the American Academy of Ophthalmology.