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

Abstract

IntroductionLatanoprostene 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).MethodsThis 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.ResultsOf 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).ConclusionOnce 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 registrationClinicalTrials.gov identifier, NCT01895972.FundingBausch & Lomb, Inc. a division of Valeant Pharmaceuticals International Inc.

Axenfeld‐Rieger syndrome

“…The findings revealed that current medical therapies do not successfully reduce IOP or impede progression of glaucoma in patients with ARS who have FOXC1 or PITX2 mutations . Currently, many new classes of glaucoma drops are also under development, such as nitrous oxide latanoprostene, rhopressa, and trabodenoson . In addition, there are several forms of laser therapy for glaucoma including laser iridotomy, laser trabeculoplasty, and laser cyclo‐ablation .…”

“…57 Currently, many new classes of glaucoma drops are also under development, such as nitrous oxide latanoprostene, rhopressa, and trabodenoson. 65 In addition, there are several forms of laser therapy for glaucoma including laser iridotomy, laser trabeculoplasty, and laser cyclo-ablation. 66 Surgery is another procedure that can be applied in the ARS patients with glaucoma such as trabeculectomy, aqueous shunt devices, and minimally invasive glaucoma surgery that have been under development in the past few years.…”

Critical evaluation of latanoprostene bunod in the treatment of glaucoma

“…However, the majority of adverse event data for LBN is derived from trials lasting 3 months or shorter. The incidence of ocular adverse events was markedly higher in the year-long JUPITER trial 74. This may indicate that the risk of developing ocular side effects increases with prolonged use.…”

“…Partial methodology and results of this trial have been published 74. Individuals ≥20 years old with either OAG or OHTN (mean baseline IOP =19.6±2.9 mmHg) were administered LBN 0.024% qPM in the study eye for a duration of 1 year.…”

Latanoprostene bunod ophthalmic solution 0.024%: a new treatment option for open‐angle glaucoma and ocular hypertension

“…On topical ocular instillation, LBN is rapidly metabolised via carboxyl ester hydrolysis into a prostaglandin F (FP) receptor agonist (latanoprost acid, the active component of latanoprost) and a nitric oxide‐donating moiety (butanediol mononitrate) . Butanediol mononitrate subsequently releases nitric oxide (active component) and the inactive metabolite 1,4 butanediol …”