Comparison of the ocular hypotensive lipid AGN 192024 with timolol - Dosing, efficacy and safety evaluation of a novel compound for glaucoma management

Objective: 70 compare the safety and efficacy of the ocular hypotensive lip id AGN 192024 (Lumigan) with those of timolol. Methods: A 30-day, randomized, investigator-masked, clinical trial involvin g 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 cont rol or 0.5% timolol was given twice daily for 4 weeks. Mean change in IOP f rom 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 ba seline (P < .001). A dosage of 0.03% AGN 192024 once daily lowered IOP sign ificantly more than timolol (P less than or equal to .02) at every study vi sit except day 21 (P =.053) and provided better diurnal IOP control. Tu ice -daily dosing of AGN 192024 provided no clinically significant benefit over once-daily dosing. All treatment regimens were safe and well tolerated, wi th no clinically significant effects on heart rate or blood pressure and tw o between-group differences in the incidence of adverse events. The only si gnificant ocular safety finding with AGN 192024 was a dose-related mild inc rease in conjunctival hyperemia. Conclusions: Of the 3 concentrations tested, 0.03%; AGN 192024 once daily h ad the best therapeutic profile. AGN 192024 was safe and well tolerated, an d it provided superior ocular hypotensive efficacy and diurnal IOP control compared with timolol in patients; with ocular hypertension and glaucoma.