Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial.

Autor: Lewis RA; Sacramento Eye Consultants, Sacramento, California. Electronic address: rlewiseyemd@yahoo.com., Christie WC; Scott & Christie and Associates, Pittsburgh, Pennsylvania., Day DG; Coastal Research Associates, Roswell, Georgia., Craven ER; Wilmer Eye Institute, Baltimore, Maryland; King Khaled Eye Specialists Hospital, Riyadh, Saudi Arabia., Walters T; Keystone Research, Ltd, Austin, Texas., Bejanian M; Allergan plc, Irvine, California., Lee SS; Allergan plc, Irvine, California., Goodkin ML; Allergan plc, Irvine, California., Zhang J; Allergan plc, Bridgewater, New Jersey., Whitcup SM; Allergan plc, Irvine, California., Robinson MR; Allergan plc, Irvine, California.
Jazyk: angličtina
Zdroj: American journal of ophthalmology [Am J Ophthalmol] 2017 Mar; Vol. 175, pp. 137-147. Date of Electronic Publication: 2016 Dec 22.
DOI: 10.1016/j.ajo.2016.11.020
Abstrakt: Purpose: To evaluate the safety and intraocular pressure (IOP)-lowering effect of a biodegradable bimatoprost sustained-release implant (Bimatoprost SR).
Design: Phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial.
Methods: At baseline following washout, open-angle glaucoma patients (n = 75) were administered Bimatoprost SR (6 μg, 10 μg, 15 μg, or 20 μg) intracamerally in the study eye; the fellow eye began topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or a single repeat treatment with implant was allowed. The primary endpoint was IOP change from baseline. The main safety measure was adverse events. Results through month 6 are reported.
Results: Bimatoprost SR provided rapid, sustained IOP lowering. Overall mean IOP reduction from baseline through week 16 in study eyes was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6-μg, 10-μg, 15-μg, and 20-μg dose strengths of implant, respectively, vs 8.4 mm Hg in topical bimatoprost-treated pooled fellow eyes (data censored at rescue/retreatment). Rescue/retreatment was not required in 91% and 71% of study eyes up to week 16 and month 6, respectively. Adverse events in study eyes usually occurred within 2 days after the injection procedure and were transient. Conjunctival hyperemia with onset later than 2 days after the injection procedure was more common with topical bimatoprost than Bimatoprost SR (17.3% vs 6.7% of eyes).
Conclusions: Bimatoprost SR demonstrated favorable efficacy and safety through 6 months. All dose strengths were comparable to topical bimatoprost in overall IOP reduction through week 16. A single administration controlled IOP in the majority of patients for up to 6 months.
(Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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