If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  ASCRS MEETING: Lotemax Eye Drops Reduces Cataract Post-Op Inflammation SAN DIEGO, CA -- April 21, 1998 -- New data on Bausch & Lomb Pharmaceuticals, Inc.’s 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. The study was presented today by Ellen Strahlman, MD, MHSc, vice president of corporate medical and scientific affairs for Bausch & Lomb, at the meeting of the American Society of Cataract and Refractive Surgery. Lotemax will be available to physicians and in American retail pharmacies by June 1. Lotemax is a topical, site-specific steroid indicated for the treatment of steroid-responsive inflammatory conditions and for postoperative inflammation of the eye. The drug 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 United States. The study was designed to assess the activity of Lotemax 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 Lotemax 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 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, multicentre 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 percent in the Lotemax group and 29 percent in the placebo group. "In addition, anterior chamber inflammation was resolved or mild in 89 percent of Lotemax patients by their final visit. Also, for other signs and symptoms, the resolution rate and mean change from baseline favoured Lotemax." 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 favour of Lotemax." In controlled trials, Lotemax has been found effective in a variety of inflammatory ocular conditions. The drug was effective in relieving the signs and symptoms of giant papillary conjunctivitis and in preventing development of the signs and symptoms of seasonal allergic conjunctivitis. In a summation of controlled, randomised studies of people treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (greater than or equal to 10 mm Hg) was two percent (15/901). As with all ophthalmic corticosteroids, Lotemax is contraindicated in most viral diseases of the cornea and conjunctiva and in mycobacterial and fungal diseases of the eye. Prolonged use of corticosteroids may result in secondary glaucoma, cataract formation and secondary ocular infections following suppression of the host response and/or perforation of the globe. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. The most common adverse events of patients treated with Lotemax were abnormal vision/blurring, burning, chemosis, discharge and dry eyes.
|
