More patients achieved complete resolution of anterior chamber cells with LOTEMAX® Ointment vs vehicle at Day 8 following cataract surgery1,2

Image

More patients treated with LOTEMAX® Ointment were pain-free vs vehicle at Day 8 following cataract surgery1,2

Image
  • In 2 Phase 3 studies, LOTEMAX® Ointment demonstrated a significantly higher rate of complete clearing of anterior chamber cells and flare* at postoperative Day 8 vs vehicle (24%-32% vs 11%-14%; P<0.0001)1,2,†
  • Significantly more patients were pain free at postoperative Day 8 vs vehicle (73%-78% vs 41%-45%; P<0.0001)1,2,†

A TOLERABILITY PROFILE YOU EXPECT FROM LOTEPREDNOL ETABONATE2

Low incidence of significant intraocular pressure (IOP) elevations2

  • Only 3 of 404 patients treated with LOTEMAX® Ointment and 1 of 401 patients treated with vehicle had an elevation of IOP ≥10 mm Hg over the course of the study†
  • If this product is used for 10 days or longer, IOP should be monitored.

*Cell count 0 and no flare.

†Study design: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 805 subjects with a combined grade of ≥3 for anterior chamber cells and flare 1 day after uncomplicated cataract surgery.

Indication

LOTEMAX® Ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Important Safety Information

  • LOTEMAX® Ointment, 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 this product is used for 10 days or longer, IOP should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation and may delay healing and increase the incidence of bleb formation after cataract surgery. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification.
  • Corticosteroids may increase the hazard of secondary ocular infections. If pain, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. Fungal culture should be taken when appropriate.
  • Patients should not wear contact lenses during their course of therapy with LOTEMAX® Ointment. LOTEMAX® should not be used in children following ocular surgery as it may interfere with amblyopia treatment. LOTEMAX® is not indicated for intraocular administration.
  • The most common ocular adverse event, reported in approximately 25% of subjects in clinical studies, is anterior chamber inflammation. Other common adverse events, with an incidence of 4-5%, are conjunctival hyperemia, corneal edema, and eye pain. Many of these events may have been the consequence of the surgical procedure.

Click here for full Prescribing Information for LOTEMAX® Ointment.

References: 1. LOTEMAX Ointment [package insert]. Tampa, FL: Bausch & Lomb Incorporated. 2. Comstock TL, Paterno MR, Singh A, et al. Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Clin Ophthalmol. 2011;5:177-186.

logo
logo

©Bausch & Lomb Incorporated. All rights reserved. LEO.0021.USA.18

CALIFORNIA RESIDENTS: DO NOT SELL MY PERSONAL INFORMATION

Indication and Important Safety Information
SHOW MORE

Indication

LOTEMAX® Ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Important Safety Information

  • LOTEMAX® Ointment, 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 this product is used for 10 days or longer, IOP should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation and may delay healing and increase the incidence of bleb formation after cataract surgery. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification.
  • Corticosteroids may increase the hazard of secondary ocular infections. If pain, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. Fungal culture should be taken when appropriate.
  • Patients should not wear contact lenses during their course of therapy with LOTEMAX® Ointment. LOTEMAX® should not be used in children following ocular surgery as it may interfere with amblyopia treatment. LOTEMAX® is not indicated for intraocular administration.
  • The most common ocular adverse event, reported in approximately 25% of subjects in clinical studies, is anterior chamber inflammation. Other common adverse events, with an incidence of 4-5%, are conjunctival hyperemia, corneal edema, and eye pain. Many of these events may have been the consequence of the surgical procedure.

Click here for full Prescribing Information for LOTEMAX® Ointment.

References: 1. LOTEMAX Ointment [package insert]. Tampa, FL: Bausch & Lomb Incorporated. 2. Drugs@FDA.com website. https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed May 30, 2018.

Click here for IMPORTANT SAFETY INFORMATION