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Dosing, Efficacy, and Safety Evaluation of a Novel Compound for Glaucoma Management

Robert A. Laibovitz, MD; Amanda M. VanDenburgh, PhD, MBA; Carlos Felix, MS; Robert David, MD; Amy Batoosingh, BA; Allan Rosenthal, PhD; Janet Cheetham, PharmD

Arch Ophthalmol. 2001;119:994-1000.

Objective  To compare the safety and efficacy of the ocular hypotensive lipid AGN 192024 (Lumigan) with those of timolol.

Methods  A 30-day, randomized, investigator-masked, clinical trial involving 100 patients with elevated intraocular pressure (IOP). Study medications were instilled topically. Doses of 0.003%, 0.01%, or 0.03% AGN 192024 were given once daily for 3 weeks then twice daily for 1 week, and vehicle control or 0.5% timolol was given twice daily for 4 weeks. Mean change in IOP from baseline was the primary efficacy variable. Safety parameters included adverse events, hyperemia grading, laser flare meter analysis, heart rate, and blood pressure.

Results  Timolol and all 3 concentrations of AGN 192024 lowered IOP from baseline (P<.001). A dosage of 0.03% AGN 192024 once daily lowered IOP significantly more than timolol (P.02) at every study visit except day 21 (P = .053) and provided better diurnal IOP control. Twice-daily dosing of AGN 192024 provided no clinically significant benefit over once-daily dosing. All treatment regimens were safe and well tolerated, with no clinically significant effects on heart rate or blood pressure and no between-group differences in the incidence of adverse events. The only significant ocular safety finding with AGN 192024 was a dose-related mild increase in conjunctival hyperemia.

Conclusions  Of the 3 concentrations tested, 0.03% AGN 192024 once daily had the best therapeutic profile. AGN 192024 was safe and well tolerated, and it provided superior ocular hypotensive efficacy and diurnal IOP control compared with timolol in patients with ocular hypertension and glaucoma.

From Eye Research Associates, Austin, Tex (Dr Laibovitz); and Allergan Inc, Ophthalmology Clinical Research, Irvine, Calif (Drs VanDenburgh, David, Rosenthal, and Cheetham, Mr Felix, and Ms Batoosingh). Dr Laibovitz was a paid evaluator and does not have any financial or proprietary interest in AGN 192024 or the study sponsor, Allergan Inc. Drs VanDenburgh, David, Rosenthal, and Cheetham, Mr Felix, and Ms Batoosingh are employees of Allergan Inc.

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