*Pooled analysis of Phase 3 clinical studies. Study 1: 29% LOTEMAX® SM (N=171) vs 9% vehicle (N=172). Study 2: 31% LOTEMAX® SM (N=200) vs 20% vehicle (N=199); P<0.05 for all.
Study Design: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 742 subjects to examine the safety and efficacy of LOTEMAX® SM in the treatment of postoperative inflammation and pain following cataract surgery. Primary efficacy endpoints were resolution of ACC and grade (0) no pain at day 8. Secondary efficacy endpoints included inflammation and grade (0) no pain at different visits (eg, day 3).
ACC=anterior chamber cell.
*Pooled analysis of phase 3 clinical studies. Study 1: 73% LOTEMAX® SM (N=171) vs 48% vehicle (N=172) at day 8. Study 2: 76% LOTEMAX® SM (N=200) vs 50% vehicle (N=199) at day 8; P<0.05 for all.
Study Design: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 742 subjects to examine the safety and efficacy of LOTEMAX® SM in the treatment of postoperative inflammation and pain following cataract surgery. Primary efficacy endpoints were resolution of ACC and grade (0) no pain at day 8. Secondary efficacy endpoints included inflammation and grade (0) no pain at different visits (eg, day 3).
Only 1 patient (N=369) experienced significant intraocular pressure (IOP) elevations ≥10 mm Hg, comparable to vehicle in clinical trials2,3
There were no treatment-emergent adverse drug reactions that occurred in more than 1% of patients, compared to vehicle in clinical trials1
If this product is used for 10 days or longer, IOP should be monitored.1