Purpose: To compare the efficacy and safety of AGN 192024 q.d. and b.i.d. with timolol b.i.d. in patients with elevated IOP.
Methods: Analysis of pooled 6-month results from two ongoing, randomized, double-masked, multicenter, clinical trials. Patients 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 (8AM, 10AM, 4PM, 8PM). Secondary outcome measures included eye examinations and safety parameters.
Results: Baseline mean IOP (8AM) in all groups was approximately 26.0 mm Hg. AGN 192024 q.d. provided significantly greater mean IOP reductions from baseline than did timolol at each time of the day and at every study visit (P<.05). AGN 192024 b.i.d. was less effective than q.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. The IOP lowering provided by AGN 192024 q.d. was sustained through 6 months. At 10AM (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.
Conclusions: Over a six-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 in patients with elevated IOP.