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

• DOI: 10.1007/s12325-016-0385-7
• Publication Date: 2016-07-25T07:19:20Z
• Authors: Kazuhide Kawase; Jason L. Vittitow; Robert N. Weinreb; Makoto Araie; ; Shigeru Hoshiai; Setsuko Hashida; Miki Iwasaki; Kiyoshi Kano; Kazuhide Kawase; Takuji Kato; Yasuaki Kuwayama; Tomoyuki Muramatsu; Masatada Mitsuhashi; Sakae Matsuzaki; Toru Nakajima; Isao Sato; Yuzuru Yoshimura
• Keywords: Jupiter (rocket family)

Abstract 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 single-arm, multicenter, open-label, clinical study. Subjects aged 20 years older diagnosis OAG OHT instilled drop affected eye(s) once daily evening for 52 weeks were every 4 weeks. Safety assessments included vital signs, comprehensive exams, treatment-emergent adverse events (AEs). Absolute percent reductions from baseline IOP also determined. Results Of 130 enrolled, 121 (93.1%) completed Mean age 62.5 years, mean (standard deviation) 19.6 (2.9) 18.7 (2.6) mmHg study eyes treated fellow eyes, respectively. Overall, 76/130 (58.5%) 78/126 (61.9%) experienced ≥1 AEs In both most common conjunctival hyperemia, growth eyelashes, eye irritation, pain. At weeks, 9% had an increase iris pigmentation compared based on photographs. No concerns emerged signs other assessments. 22.0% 19.5% achieved by week These maintained through ( P < 0.001 vs. at all visits). Conclusion Once safe well-tolerated when used up to year. Long-term treatment provided significant sustained reduction. Trial registration ClinicalTrials.gov identifier, NCT01895972. Funding Bausch & Lomb, Inc. division Valeant Pharmaceuticals International