MADISON, NJ—Bausch + Lomb, the global eye health company, has added a
new product to its signature loteprednol etabonate line: LOTEMAX®
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
- 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
- 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.
Please click here for full prescribing information(381 KB, PDF)
About Bausch + Lomb
Lotemax® is a registered trademark of Bausch & Lomb, Incorporated.
Bausch + Lomb is one of the best-known and most respected
healthcare companies in the world. Its core businesses include contact
lenses and lens care products, ophthalmic surgical devices and
instruments, and ophthalmic pharmaceuticals. Founded in 1853, the
company is headquartered in Rochester, N.Y., and employs more than
10,000 people worldwide. Its products are available in more than 100
countries. More information is available at www.bausch.com