CLINICAL EVALUATIONS of AGN 192024 (LUMIGAN™). I. Goldberg¹ and L. Cantor² for the AGN 192024 Study Groups I & II. ¹Sydney Eye Hospital and the Save Sight Institute, University of Sydney, Australia; ²University of Indiana, IN, USA.

AGN 192024 (Lumigan™) has been evaluated as monotherapy and adjunctive therapy in several large, controlled clinical trials. Pooled 6-month results from 2 randomized, double-masked, multicenter trials were analyzed. Patients with glaucoma or ocular hypertension received AGN 192024 0.03% q.d. (N=474), AGN 192024 0.03% b.i.d. (N=483), or timolol 0.5% b.i.d. (N=241). Study visits were at baseline, week 2, week 6, month 3, and month 6. The primary outcome measure was diurnal IOP (8 AM, 10 AM, 4 PM, 8 PM). Baseline mean IOP (8 AM) in all groups was approximately 26.0 mm Hg. Mean IOP reductions from baseline were significantly greater with AGN 192024 q.d. than with timolol at every timepoint (P<.05). Once-daily dosing of AGN 192024 was more effective than b.i.d. dosing. Ranges for mean diurnal IOP at month 6 were 16.6-17.7 mm Hg with AGN 192024 q.d., 17.0-18.7 mm Hg with AGN 192024 b.i.d., and 18.4-19.3 mm Hg with timolol. At 10 AM (peak timolol effect) at month 6, IOP <17 mm Hg was achieved by 63.9% of AGN 192024 q.d. patients compared with 37.3% of timolol patients (P<.001). AGN 192024 appeared to be safe and well-tolerated, with few discontinuations due to adverse events. Over a 6-month period, AGN 192024 q.d. provided statistically significant and clinically relevant IOP lowering superior to timolol b.i.d. and appeared to be safe and well-tolerated. Results from this trial and other clinical trials to be presented suggest that AGN 192024 may set a new standard for IOP lowering.