Bausch + Lomb Launches LOTEMAX® Ointment

The FINANCIAL — MADISON, NJ—Bausch + Lomb, the global eye health company, has added a new product to its signature loteprednol etabonate line: LOTEMAX® Ointment.

LOTEMAX Ointment is indicated to treat post-operative inflammation and pain following ocular surgery. LOTEMAX Ointment is the first preservative-free topical ophthalmic steroid formulation in the U.S. It is also the first monotherapy steroid ointment brought to the U.S. market in over 20 years.

“Loteprednol is a molecule I’ve grown to trust because of its effective anti-inflammatory activity,” said Terry Kim, M.D., of Duke University Eye Center. “A preservative-free steroid is something we have anticipated for some time now. LOTEMAX Ointment offers me one more option to provide to my patients.”

Two four-week clinical safety and efficacy evaluations of LOTEMAX Ointment showed statistically significant resolution of anterior chamber cells and flare vs. vehicle at post-operative day eight. Both clinical trials were Phase 3, randomized, multi-center, double-masked parallel-group comparative evaluations to a vehicle (mineral oil and white petrolatum) for the treatment of inflammation and pain following cataract surgery (N=805 total) with LOTEMAX Ointment.

Bausch + Lomb is currently shipping LOTEMAX Ointment. The product is available only within the United States.

Important Risk Information about LOTEMAX® Ointment

•     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 two 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 percent of subjects in clinical studies, is anterior chamber inflammation. Other common adverse events, with an incidence of 4-5 percent, are conjunctival hyperemia, corneal edema, and eye pain.  Many of these events may have been the consequence of the surgical procedure.