title: Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study.
abstract: Latanoprostene bunod (LBN) is a novel nitric oxide (NO)-donating prostaglandin F2α analog. We evaluated the long-term safety and intraocular pressure (IOP)-lowering efficacy of LBN ophthalmic solution 0.024% over 1 year in Japanese subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
  
  
  
  This was a single-arm, multicenter, open-label, clinical study. Subjects aged 20 years and older with a diagnosis of OAG or OHT instilled 1 drop of LBN ophthalmic solution 0.024% in the affected eye(s) once daily in the evening for 52 weeks and were evaluated every 4 weeks. Safety assessments included vital signs, comprehensive ophthalmic exams, and treatment-emergent adverse events (AEs). Absolute and percent reductions from baseline in IOP were also determined.
  
  
  
  Of 130 subjects enrolled, 121 (93.1%) completed the study. Mean age was 62.5 years, and mean (standard deviation) baseline IOP was 19.6 (2.9) and 18.7 (2.6) mmHg in study eyes and treated fellow eyes, respectively. Overall, 76/130 (58.5%) and 78/126 (61.9%) subjects experienced ≥1 AEs in study eyes and treated fellow eyes, respectively. In both study eyes and treated fellow eyes, the most common AEs were conjunctival hyperemia, growth of eyelashes, eye irritation, and eye pain. At 52 weeks, 9% of treated eyes had an increase in iris pigmentation compared with baseline based on iris photographs. No safety concerns emerged based on vital signs or other ocular assessments. Mean reductions from baseline in IOP of 22.0% and 19.5% were achieved by week 4 in study and treated fellow eyes, respectively. These reductions were maintained through week 52 (P < 0.001 vs. baseline at all visits).
  
  
  
  Once daily LBN ophthalmic solution 0.024% was safe and well-tolerated in Japanese subjects with OAG or OHT when used for up to 1 year. Long-term treatment with LBN ophthalmic solution 0.024% provided significant and sustained IOP reduction.
  
  
  
  ClinicalTrials.gov identifier, NCT01895972.
  
  
  
  Bausch & Lomb, Inc. a division of Valeant Pharmaceuticals International Inc.
authors.affiliation: Gifu University Hospital, Gifu, Japan. kawase-gif@umin.ac.jp.
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Kawase
authors.affiliation: Clinical Affairs, Bausch + Lomb, Bridgewater, NJ, USA.
authors.forename: Jason L
authors.initials: JL
authors.lastname: Vittitow
authors.affiliation: Department of Ophthalmology and Shiley Eye Institute, Hamilton Glaucoma Center, University of California San Diego, La Jolla, CA, USA.
authors.forename: Robert N
authors.initials: RN
authors.lastname: Weinreb
authors.affiliation: Kanto Central Hospital of The Mutual Aid Association of Public School Teachers, Tokyo, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Araie
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects; D003229:Conjunctival Diseases / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control; D015237:Dinoprost; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005902:Glaucoma, Open-Angle / Q000175:diagnosis / Q000188:drug therapy; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D007564:Japan; D000069451:Long Term Adverse Effects / Q000139:chemically induced / Q000175:diagnosis / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage / Q000009:adverse effects; D014065:Tonometry, Ocular / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; C568859:BOL 303259-X; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D015237:Dinoprost
keywords: Intraocular pressure; Nitric oxide; Ocular hypertension; Open-angle glaucoma; Ophthalmology; Prostaglandin