34-Week Data Analysis from Second Clinical Trial of Bausch & Lomb's Retisert Implant for Posterior Uveitis is Presented At The Retina Society Annual Meeting.ROCHESTER, N.Y. -- Bausch & Lomb (NYSE NYSE See: New York Stock Exchange : BOL BOL Bolivia (ISO Country code) BOL Books Online BOL Bole (SIL code, Nigeria) BOL Bill Of Lading BOL Beginning Of Line BOL Best Of Luck BOL Buzz Out Loud BOL Bruin Online BOL Beginning Of Life ) --Implanted Eyes Showed Statistically Significant Decrease in Uveitis uveitis Inflammation of the uvea, the middle coat of the eyeball. Anterior uveitis, involving the iris or ciliary body (containing the muscle that adjusts the lens) or both, can lead to glaucoma and blindness. Recurrence Rate Post-implantation; And as Compared to Fellow Eye --Visual Acuity Improved by At Least Three Lines in 21 Percent of Eyes --Adverse Events were Managed by Conventional Means Analysis of 34-week results of an international, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , dose-masked, multi-center clinical trial designed to assess the safety and efficacy of the Retisert(TM) implant for the treatment of non-infectious posterior uveitis were presented by principal investigator Dr. Robert Devenyi, Ophthalmologist-in-Chief and Director of Retinal Services at the University Health Network and professor of ophthalmology at the University of Toronto Research at the University of Toronto has been responsible for the world's first electronic heart pacemaker, artificial larynx, single-lung transplant, nerve transplant, artificial pancreas, chemical laser, G-suit, the first practical electron microscope, the first cloning of T-cells, , Canada, at the Annual Meeting of the Retina Society in Baltimore, Maryland on Saturday, October 2, 2004. This trial was designed to confirm the results of the first pivotal trial of the implant, which were reported in 2003. The data presented by Dr. Devenyi relate to a trial conducted at 19 centers in Canada, the United States, Australia, India, the Philippines and Hong Kong. 239 patients with non-infectious posterior uveitis were randomized to receive either a 0.59 mg or a 2.1 mg Retisert implant in the affected eye or, in bilateral cases, in the more severely afflicted eye. The fellow eye was implant free. Devenyi reported that for the aggregate results of the two doses at 34 weeks, the uveitis recurrence rate (the targeted outcome of this trial) was statistically lower (p less than 0.0001) in those eyes with the Retisert implant (10.0 percent) compared to the recurrence rate in the fellow eyes (55.7 percent). There was also statistically significant improvement in visual acuity visual acuity n. Sharpness of vision, especially as tested with a Snellen chart. Normal visual acuity based on the Snellen chart is 20/20. Visual acuity The ability to distinguish details and shapes of objects. (p less than 0.05) in the implanted eyes, but no statistically significant change in mean visual acuity in the fellow eyes. Importantly, 20.9 percent of the implant eyes had an improvement in vision of three or more lines. Overall, at 34 weeks, there was a statistically significant decrease in the use of systemic corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and and/or immunosuppressant immunosuppressant /im·mu·no·sup·pres·sant/ (-sah-pres´ant) an agent capable of suppressing immune responses. im·mu·no·sup·pres·sant n. An agent that suppresses the body's immune response. therapy, use of periocular injections and use of topical steroid eye drops to control inflammation in implanted eyes. At 34 weeks the most common adverse events included cataract progression and increased intraocular pressure intraocular pressure n. The pressure of the intraocular fluid within the eye. intraocular pressure (in´tr - which were anticipated given the nature of the disease and the type of drug used, and were managed by conventional means. "These results solidly confirm the results of the first pivotal trial and show that this drug delivery technology, combined with the well-known steroid fluocinolone acetonide fluocinolone acetonide a corticosteroid anti-inflammatory used topically in the treatment of skin diseases and inflammation of anal sacs. Called also Synalar. , reduces the recurrence of posterior uveitis," said Gary M. Phillips MD, vice president-global pharmaceuticals for Bausch & Lomb. "The unmasked results of the two trials will be submitted to the U.S. Food and Drug Administration for approval of the Retisert implant for the treatment of posterior uveitis and we continue to target commercialization in 2005." This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of Bausch & Lomb. Such statements involve a number of risks and uncertainties including, without limitation, those concerning global and local economic, political and sociological conditions; currency exchange rates; government pricing changes and initiatives with respect to healthcare products; changes in laws and regulations relating to the Company's products and the import and export of such products; product development and rationalization; enrollment and completion of clinical trials; the ability of the Company to obtain regulatory approvals; the outcome of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. ; the success of product introductions; the financial well-being of key customers, development partners and suppliers; the successful execution of marketing strategies; the continued successful implementation of the Company's efforts in managing and reducing costs and expenses; the Company's success in the process of management testing and auditor attestation of internal controls, as required under the Sarbanes-Oxley Act See SOX. of 2002; the Company's success in introducing and implementing its enterprise-wide information technology initiatives, including the corresponding impact on controls and reporting; continued positive relations with third party financing sources and the risk factors listed from time to time in the Company's SEC filings, including but not limited to the current report on Form 8-K, dated June 14, 2002 and the Form 10-Q for the quarter ended, June 26, 2004. Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Celebrating its 150th anniversary, the Company is headquartered in Rochester, New York This article is about the city of Rochester in Monroe County. For the town in Ulster County, see Rochester, Ulster County, New York. Rochester, once known as The Flour City, and more recently as The Flower City or . Bausch & Lomb's 2003 revenues were $2 billion; it employs approximately 11,500 people worldwide and its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Web site at www.bausch.com. Copyright Bausch & Lomb. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion