FDA approves Bausch & Lomb's Retisert orphan drug for chronic, non-infectious uveitis
ROCHESTER, N.Y., April 11, 2005 -- Bausch & Lomb announced that the FDA has approved the single-indication orphan drug Retisert (fluocinolone acetonide intravitreal implant), 0.59 mg, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, a sight-threatening inflammatory disease that primarily afflicts people between the ages 20 and 50, during their prime working years.
Retisert is the world's first intravitreal drug implant for the treatment of this 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.
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.
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, visit 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
Posted: April 2005