Text size A - A+

RSS

FOR RELEASE 10/1/2012, Monday

Bausch + Lomb Receives FDA Approval of LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5% Gel Drop Formulation

New Gel Formulation of Loteprednol Corticosteroid Indicated
for Post Ocular Surgery Inflammation and Pain

MADISON, N.J. — Bausch + Lomb, the global eye health company, today announced that  the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5 percent gel drop formulation, a new topical corticosteroid formulation in its line of loteprednol ophthalmic products. LOTEMAX Gel is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.

About LOTEMAX Gel
LOTEMAX Gel is a topical ocular treatment for post-operative inflammation and pain in patients who have had ocular surgery.  Loteprednol etabonate (LE), the active ingredient in LOTEMAX Gel, was first approved as an ocular anti-inflammatory agent by the FDA in 1998. In 2011, the total U.S. market for ophthalmic steroids was $260 million with more than six million prescriptions written each year.

Dosage and Administration
Apply one or two drops of LOTEMAX Gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first two weeks of the post-operative period.

Dosage Forms and Strengths
Topical ophthalmic gel: loteprednol etabonate ophthalmic gel 0.5 percent.

Important Safety Information about LOTEMAX Gel

Contraindications

  • LOTEMAX Gel, 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. Ocular viral infections may be prolonged or exacerbated.

Warnings and Precautions

  • Intraocular pressure (IOP) increase: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, IOP should be monitored.
  • Cataracts: Use of corticosteroids may result in posterior subcapsular cataract formation.
  • Delayed healing: Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation and occurrence of perforations in those with diseases causing corneal and scleral thinning. 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.
  • Bacterial infections: Prolonged use of corticosteroids may increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections.
  • Viral infections: In treatment of patients with a history of herpes simplex, use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye.
  • Fungal infections: 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.
  • Contact Lens wear: Patients should not wear contact lenses during their course of therapy with LOTEMAX Gel.

Adverse Reactions

  • The most common ocular adverse reactions reported in patients treated with LOTEMAX Gel were anterior chamber inflammation (5 percent), eye pain (2 percent) and foreign body sensation (2 percent).

About Bausch + Lomb
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 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.

®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2012 Bausch & Lomb Incorporated.

# # #

News Media Contacts
Jeanie Herbert
Global Surgical Communications, Bausch + Lomb
(949) 521-7948, (714) 325-3584 (mobile) or jeanie.herbert@bausch.com

Elizabeth Murphy
Global Communications, Bausch + Lomb
(585) 338-8528 or elizabeth.murphy@bausch.com

Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937 or theitmann@BioCommNetwork.com