FDA approves Bausch & Lomb's Retisert orphan drug

April 16, 2005

Washington, DC &#8212 Bausch & Lomb announced that the U.S. Food and Drug Administration 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.

April 17 - Washington, DC - 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.

The intravitreal drug implant received FDA Fast Track status, according to the company. It also received FDA Orphan Drug designation for this indication. Bausch & Lomb is targeting a mid-year launch of the product, the company said in a prepared statement.

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 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 3-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.