title: Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study.
abstract: OBJECTIVE
  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 open-angle glaucoma (OAG) or ocular hypertension (OHT).
  
  
  METHODS
  Phase 3, randomized, controlled, multicenter, double-masked, parallel-group clinical study.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Hamilton Glaucoma Center, Shiley Eye Institute and Department of Ophthalmology, University of California San Diego, La Jolla, California. Electronic address: Rweinreb@ucsd.edu.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Weinreb
authors.affiliation: Bausch & Lomb, Bridgewater, New Jersey.
authors.forename: Baldo
authors.initials: B
authors.lastname: Scassellati Sforzolini
authors.affiliation: Bausch & Lomb, Bridgewater, New Jersey.
authors.forename: Jason
authors.initials: J
authors.lastname: Vittitow
authors.affiliation: Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia University Medical Center, New York, New York.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Liebmann
mesh_terms: D000287:Administration, Topical; D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D002940:Circadian Rhythm / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy / Q000503:physiopathology; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D013999:Timolol / Q000627:therapeutic use*; D014065:Tonometry, Ocular; D055815:Young Adult
chemical_list: D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; C568859:BOL 303259-X; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D013999:Timolol