Bausch & Lomb reports implant data in posterior uveitis:
[Bausch dropped its program in AMD and diabetic macular edema earlier this year (#msg-2341249) but it has continued to develop the Retisert implant for posterior uveitis. Without a program in AMD, Bausch could yet be a partner for GENR’s Squalamine.]
>> 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
• Implanted Eyes Showed Statistically Significant Decrease in Uveitis 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, 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, 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 (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 and/or immunosuppressant 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 - 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, 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." <<
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