Evaluation of the Effect of Latanoprostene Bunod Ophthalmic Solution, 0.024% in Lowering Intraocular Pressure over 24 h in Healthy Japanese Subjects.

Abstract

INTRODUCTION:

Latanoprostene bunod is a novel nitric oxide (NO)-donating prostaglandin F2α receptor agonist in clinical development for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. We evaluated the effect of latanoprostene bunod 0.024% instilled once daily (QD) on lowering IOP over a 24-h period in healthy Japanese subjects following 14 days of treatment.

METHODS:

This was a single-arm, single-center, open-label clinical study of 24 healthy Japanese male volunteers. A baseline IOP profile was established in both eyes in the sitting position at 8 PM, 10 PM, 12 AM, 2 AM, 4 AM, 8 AM, 10 AM, 12 PM, and 4 PM using a Goldmann applanation tonometer. Subjects subsequently instilled latanoprostene bunod 0.024% QD at 8 PM for 14 days in both eyes. The absolute and change from baseline in sitting IOP was assessed on day 14.

RESULTS:

The mean (SD) age of the subjects was 26.8 (6.3) years, and mean (SD) baseline IOP was 13.6 (1.3) mmHg in the study eye. Latanoprostene bunod 0.024% instilled QD for 14 days reduced IOP at all the evaluated time points (P < 0.001) with a mean (SD) 24-h reduction of 3.6 (0.8) mmHg or 27% from the baseline in the study eye. Peak and trough IOP lowering occurred at 8 AM and 8 PM (12 and 24 h following instillation) with a mean reduction of 4.2 (1.8) mmHg, or 30%, and 2.8 (2.2) mmHg, or 20%, respectively. Punctate keratitis and ocular hyperemia, both mild in severity, were the most common adverse events.

CONCLUSION:

Latanoprostene bunod ophthalmic solution 0.024%, dosed QD for 14 days, significantly lowered mean IOP in healthy Japanese subjects during the entire 24-h period. Studies of latanoprostene bunod in patients diagnosed with normal tension glaucoma are warranted.

TRIAL REGISTRATION:

Clinicaltrials.gov identifier NCT01895985.

FUNDING:

Bausch & Lomb, Inc.

• Authors: Makoto Araie, Baldo Scassellati Sforzolini, Jason Vittitow, Robert N Weinreb
• Journal: Advances in therapy (Adv Ther) Vol. 32 Issue 11 Pg. 1128-39 (Nov 2015) ISSN: 1865-8652 [Electronic] United States
• PMID: 26563323 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• BOL 303259-X
• Ophthalmic Solutions
• Prostaglandins F, Synthetic
• Dinoprost

Topics

• Adult
• Antihypertensive Agents (administration & dosage, adverse effects, therapeutic use)
• Asian People
• Dinoprost (agonists)
• Double-Blind Method
• Glaucoma, Open-Angle (drug therapy)
• Humans
• Intraocular Pressure (drug effects)
• Japan
• Male
• Ophthalmic Solutions (administration & dosage, therapeutic use)
• Prostaglandins F, Synthetic (administration & dosage, adverse effects, therapeutic use)
• Tonometry, Ocular