2x Inflammation Clearance1,2

Inflammation clearance in
2x as many patients1,2

*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

More Pain-Free Patients1,2

*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.

Rapid Pain Resolution at Day 3
~48 hours after starting treatment2

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. Second efficacy endpoints included inflammation and grade (0) no pain at different visits (eg, Day 3).

The Safety Profile You Demand for Your Patients

Low RISK
of IOP elevations

Only 0.3% of patients (1/369) experienced significant intraocular pressure (IOP) elevations ≥ 10 mm Hg, comparable to vehicle in clinical trials2,3

Low RISK
of adverse events

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

INDICATION

LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

IMPORTANT SAFETY INFORMATION
  • LOTEMAX® SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
  • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If LOTEMAX® SM is used for 10 days or longer, IOP should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation.
  • The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those with diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
  • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections.
  • Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
  • Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate.
  • Contact lenses should not be worn when the eyes are inflamed.
  • There were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for full Prescribing Information for LOTEMAX® SM.

References: 1. LOTEMAX SM [prescribing information]. Bridgewater, NJ: Bausch & Lomb, Inc. 2. Data on file. Bridgewater, NJ: Bausch & Lomb, Inc. 3. Fong R, Silverstein BE, Peace JH, Williams JI, Vittitow JL. Submicron loteprednol etabonate ophthalmic gel 0.38% for the treatment of inflammation and pain after cataract surgery. J Cataract Refract Surg. 2018;44(10):1220-1229.