New LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5% in a Gel Drop Formulation Available in Pharmacies January 2013
Unique Corticosteroid Gel Dispensed as a Drop Formulation is Designed
to Adhere to the Ocular Surface and Provide Dose Uniformity
CHICAGO, IL—Bausch + Lomb, the global eye health company, today announced that LOTEMAX® (loteprednol etabonate ophthalmic gel) 0.5 percent, which received U.S. Food and Drug Administration (FDA) approval in late September 2012 to treat post-operative inflammation and pain following ocular surgery, will be available January 2013 in pharmacies nationwide.
"LOTEMAX GEL is a first-in-class gel drop, which represents a unique formulation technology for ophthalmic corticosteroid medications." said Calvin W. Roberts, M.D., executive vice president and chief medical officer of Bausch + Lomb. "Compared to suspensions, the gel drop formulation is more viscous, allowing it to adhere to the ocular surface."
Another important feature of the LOTEMAX GEL formulation is that it provides dose uniformity, ensuring that a consistent concentration of loteprednol is delivered in every drop, which is not always possible with corticosteroid suspension formulations. LOTEMAX GEL is also the only ocular steroid formulation containing glycerin and propylene glycol, two known moisturizers, and has a lower concentration of preservative than LOTEMAX (lotepredenol etabonate ophthalmic suspension) 0.5 percent suspension.
“Loteprednol is a proven steroid because of its effective anti-inflammatory activity and established safety profile,” said Rajesh K. Rajpal, M.D., medical director and founder of SeeClearly Vision Group, L.L.C in the Washington, D.C area. “This new loteprednol gel formulation offers eye care professionals and patients a gel drop formulation for post-operative use with greater viscosity designed to adhere to the ocular surface with a low incidence of blurriness (0.25 percent; 1/407). There is also no shaking required to re-suspend the active ingredient, which gives physicians additional confidence that their patients will receive consistent dosing.”
In two four-week clinical safety and efficacy evaluations, LOTEMAX GEL 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 vehicle controlled studies in patients (N=813) being treated for inflammation and pain following cataract surgery. Ocular adverse drug reactions reported in patients treated with LOTEMAX GEL were eye pain, anterior chamber inflammation, lacrimation increased, photophobia, eye irritation and eye pruritus. Drug-related blurred vision was rarely reported (0.25 percent; 1/407).
About LOTEMAX GEL
LOTEMAX GEL is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
The LOTEMAX Legacy
Loteprednol etabonate, the active ingredient in LOTEMAX GEL, was first approved as an ocular anti-inflammatory agent by the FDA in 1998 as LOTEMAX® (lotepredenol etabonate ophthalmic suspension) 0.5 percent, indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
Dosage and Administration
Invert closed bottle and shake once to fill tip before instilling drops. Apply one or two drops of LOTEMAX GEL into the affected eye(s) four times daily 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 Risk Information about LOTEMAX GEL
Warnings and Precautions
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.
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