Long-term Safety and Efficacy of Latanoprostene Bunod 0.024% in Japanese Subjects with Open-Angle Glaucoma or Ocular Hypertension: The JUPITER Study

• Published in: Advances in therapy Vol. 33; no. 9; pp. 1612 - 1627
• Main Authors: Kawase, Kazuhide, Vittitow, Jason L., Weinreb, Robert N., Araie, Makoto
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.09.2016
• Subjects: Antihypertensive Agents - administration & dosage; Antihypertensive Agents - adverse effects; Cardiology; ClinicalTrials.gov identifier; Conjunctival Diseases - chemically induced; Conjunctival Diseases - diagnosis; Conjunctival Diseases - prevention & control; Dinoprost; Drug Monitoring - methods; Endocrinology; Female; Glaucoma, Open-Angle - diagnosis; Glaucoma, Open-Angle - drug therapy; Humans; Internal Medicine; Intraocular Pressure - drug effects; Japan; Long Term Adverse Effects - chemically induced; Long Term Adverse Effects - diagnosis; Long Term Adverse Effects - prevention & control; Male; Medicine; Medicine & Public Health; Middle Aged; NCT01895972; Oncology; Ophthalmic Solutions - administration & dosage; Ophthalmic Solutions - adverse effects; Original Research; Pharmacology/Toxicology; Prostaglandins F, Synthetic - administration & dosage; Prostaglandins F, Synthetic - adverse effects; Rheumatology; Tonometry, Ocular - methods; Treatment Outcome; Ophthalmology; Prostaglandin; Open-angle glaucoma; Nitric oxide; Ocular hypertension; Intraocular pressure
• ISSN: 0741-238X; 1865-8652; 1865-8652
• DOI: 10.1007/s12325-016-0385-7

Introduction 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). Methods 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. Results 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). Conclusion 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. Trial registration ClinicalTrials.gov identifier, NCT01895972. Funding Bausch & Lomb, Inc. a division of Valeant Pharmaceuticals International Inc.