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FOR RELEASE 11/9/2012, Friday

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

Contraindications:

  • LOTEMAX GEL 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.

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. 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 suppress the host response
    and thus increase the hazard of secondary ocular infection. In acute purulent conditions,
    steroids may mask infection or enhance existing infections.
  • Viral infections – Use of corticosteroid medication in the treatment of patients with a
    history of herpes simplex requires great caution. Use of ocular steroids may prolong the
    course and exacerbate the severity of many viral infections of the eye (including herpes
    simplex).
  • 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 when using LOTEMAX
    GEL.

Adverse Reactions

  • The most common ocular adverse drug reactions 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.

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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