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Fluocinolone Acetonide Intravitreal Implant Approved by FDA
Bausch & Lomb's Retisert is the world's first intravitreal drug implant for the treatment of this devastating condition that affects an estimated 175,000 people in the United States and an estimated 800,000 people worldwide. The product received FDA Fast Track status, designed to allow for priority review of novel therapies for serious diseases for which there is an unmet medical need. It also received FDA Orphan Drug designation for this indication. Bausch & Lomb is targeting a mid-year launch of the product.
"Retisert represents a major therapeutic advance in treating posterior segment uveitis. It provides an effective treatment for this condition, and has allowed my patients who required long-term steroids or immunosuppressive therapy to avoid the complications of these systemic medications," said Daniel F. Martin, M.D., Thomas M. Aaberg Professor of Ophthalmology at Emory University, Atlanta and director of the Retina Service at Emory Eye Center.
According to David Callanan, M.D., Texas Retina Associates and assistant clinical professor at the University of Texas Southwestern Medical School in Dallas, "The approval of Retisert is great news for people suffering from posterior segment uveitis whose quality of life and vision are threatened by this disease. I am grateful that Bausch & Lomb has invested over many years to bring to market this orphan drug - a truly unique, breakthrough technology."
Bausch & Lomb's patented drug-delivery microtechnology in Retisert consists of a tiny drug reservoir designed to deliver sustained levels of the well-known anti-inflammatory corticosteroid, fluocinolone acetonide, for approximately two-and-a-half years (30 months) directly to the back of the eye.
"I believe that with its unique drug-delivery technology, Retisert will offer an efficacious treatment for this chronic, severe blinding disease," said Glenn J. Jaffe, M.D., professor of Ophthalmology and director of the Uveitis Service at Duke University Eye Center, Durham, N.C.
"FDA approval of Retisert represents a significant milestone in Bausch & Lomb's pursuit of new therapies and technologies to treat posterior segment diseases," said Gary M. Phillips, M.D., Bausch & Lomb corporate vice president - Global Pharmaceuticals and Vitreoretinal. "The result of many years of investment in research and development, Retisert embodies our commitment to perfecting vision and enhancing life."
FDA approval of the single-indication orphan drug was based on 34-week results from two three-year randomized, double-masked, multicenter clinical studies demonstrating that in eyes with Retisert there was:
-- a statistically significant decrease in the recurrence of uveitis from approximately 40% to 54% for the 34-week period pre-implantation to approximately 7% to 14% for the 34-week period post-implantation;
-- a statistically significant decrease in the use of adjunctive therapy including systemic corticosteroid and/or immunosuppressive therapy from approximately 47% to 63% at the time of implantation to approximately 5% to 10% at 34 weeks post-implantation, and for patients needing periocular corticosteroid injections from approximately 50% to 65% for the 34 week period pre-implantation to approximately 3% to 6% for the 34 week period post-implantation;
-- statistically significant improvement of three or more lines of visual acuity in approximately 19% to 21% of study eyes at 34 weeks post-implantation.
The most common adverse events - which were anticipated given the nature of the disease and the type of drug used - include cataract progression, which is managed by standard cataract surgery; increased intraocular pressure, which is managed with the use of IOP-lowering eye drops or filtering surgery; and procedural complications and eye pain. For full prescribing information, click the link in the news release on www.Bausch.com.
Two-year results of a randomized, double-masked, multicenter controlled clinical trial of Retisert will be presented on May 3 at the annual meeting of the Association for Research in Vision and Ophthalmology in Ft. Lauderdale, Fla.
Source: Bausch & Lomb