Retisert granted FDA approval

ROCHESTER, N.Y. — An intravitreal implant for the treatment of chronic noninfectious uveitis affecting the posterior segment was granted U.S. regulatory approval as an orphan drug, according to Bausch & Lomb.

The Food and Drug Administration approved Retisert (fluocinolone acetonide intravitreal implant, Bausch & Lomb) 0.59 mg earlier this month. A press release from Bausch & Lomb noted that the disease affects almost 175,000 people in the United States and perhaps 800,000 worldwide. The orphan drug designation grants B&L 7-year exclusivity on the product.

Retisert received fast track status from the FDA, as well as the orphan drug designation. B&L is targeting a mid-year launch, according to the company press release.

Retisert allows patients with chronic non-infectious uveitis “who required long-term steroids or immunosuppressive therapy to avoid the complications of these systemic medications,” said Daniel F. Martin, MD, director of the retina service at Emory Eye Center.

According to B&L, the “patented drug-delivery microtechnology in Retisert consists of a tiny drug reservoir designed to deliver sustained levels” of fluocinolone acetonide for about 30 months to the posterior segment.

The FDA approval was based on 34-week results from two 3-year randomized, double-masked multicenter trials, according to B&L. In patients receiving the implant, a statistically significant decrease in recurrence of uveitis was seen, dropping from 40% to 54% in the 34-week period before Retisert implantation to between 7% and 14% in the 34-week period after implantation. In addition, patients had a statistically significant decrease in the use of adjunctive therapy and a statistically significant improvement of 3 or more lines of visual acuity.

The B&L press release did not state how many patients were involved in the trials. Two-year results with the device are to be presented at the Association for Research in Vision and Ophthalmology meeting next month, according to B&L.