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To: Ariella who wrote (621)4/21/1998 8:08:00 AM
From: cm  Read Replies (2) | Respond to of 1491
 
Lifted This Bit From Yahoo! PARS...

New Data Demonstrates Value of Lotemax(TM) Ophthalmic Steroid In Treating
Postcataract Surgery Inflammation

SAN DIEGO, April 20 /PRNewswire/ -- New data on Lotemax(TM) (loteprednol
etabonate ophthalmic suspension 0.5%) show that the product offers a clinically
meaningful reduction in the signs and symptoms of cataract postoperative anterior
chamber inflammation when compared to placebo, according to a study presented
today at the meeting of the American Society of Cataract and Refractive Surgery.
Lotemax(TM) will be available to physicians and in retail pharmacies by June 1.
Lotemax(TM), a product of Bausch & Lomb Pharmaceuticals, Inc., is a new, topical,
site-specific steroid indicated for the
treatment of steroid-responsive inflammatory conditions and for postoperative
inflammation of the eye. Lotemax(TM) features a unique
mechanism of action that predictably transforms the drug into an inactive metabolite and
effectively reduces both internal and
external inflammation. It also has the broadest range of indications among all ophthalmic
steroids commercially available in the U.S.
The study was designed to assess the activity of Lotemax(TM) dosed one drop into the
operated eye four times a day for 14
days in treating inflammation in patients after cataract surgery with intraocular lens
implantation. According to the results,
presented by Ellen Strahlman, MD, MHSc, vice president of Corporate Medical and
Scientific Affairs for Bausch & Lomb, Lotemax(TM)
showed a clinical and statistically significant difference over its placebo vehicle in the
treatment of postoperative inflammation.
There was no evidence of rebound signs after cessation of therapy, and the safety
profile of Lotemax(TM) was excellent, with
little evidence of clinically significant elevations in intraocular pressure or deleterious
effects on postoperative recovery.
''This was a double-masked, placebo-controlled, parallel-group, multicenter study in
227 patients with moderate to severe
cell and flare within the day following surgery,'' Dr. Strahlman said. ''The proportion of
patients with anterior chamber
inflammation completely resolved by the final visit was 64% in the Lotemax(TM) group
and 29% in the placebo group. In addition, anterior
chamber inflammation was resolved or mild in 89% of Lotemax(TM) patients by their
final visit. Also, for other signs and symptoms,
the resolution rate and mean change from baseline favored Lotemax(TM).
''Both treatments were well tolerated,'' she added. ''The difference in the treatment
failure rates, as well as the difference in the time-course of failures, was both clinically
meaningful and statistically significant, in favor of Lotemax(TM).''
In controlled trials, Lotemax(TM) has been found effective in a variety of inflammatory
ocular conditions. Lotemax(TM) was effective in relieving the signs and symptoms of
giant papillary conjunctivitis (Asbell et al, 1997; Friedlaender et al, 1997) and in
preventing development of the signs and symptoms of seasonal allergic conjunctivitis
(Dell et al, 1997).
LOTEMAX(TM) is a trademark of Pharmos Corporation. LOTEMAX(TM) is
manufactured by Bausch & Lomb Pharmaceuticals, Inc., under Agreement with
Pharmos Corporation. PH#1155,4/98