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