ISTA Pharmaceuticals has asked the FDA not to give tentative or final approval of any abbreviated new drug application for bromfenac sodium ophthalmic solution 0.09% that uses the labeling for the company?s discontinued twice-daily brand (Xibrom) or omits any portion of the label for its once-daily brand (Bromday) relating to the once-daily dosing.
Irvine, CA-ISTA Pharmaceuticals has asked the FDA not to give tentative or final approval of any abbreviated new drug application for bromfenac sodium ophthalmic solution 0.09% that uses the labeling for the company’s discontinued twice-daily brand (Xibrom) or omits any portion of the label for its once-daily brand (Bromday) relating to the once-daily dosing. The agency, which received the request March 1, is required to respond within 180 days.
The FDA has raised potential safety concerns related to the use of the entire class of ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) and has said that patients receiving these compounds after cataract surgery should receive only the lowest effective dose, according to the company.
ISTA filed a citizen petition based on results of its head-to-head study comparing its once-daily bromfenac 0.09% formulation with bromfenac 0.18%, also used once daily. That study demonstrated that the 0.09% formulation is the lowest effective dose of bromfenac ophthalmic solution for treating postoperative inflammation and reduction in ocular pain post-cataract surgery, according to the company.
The FDA approved the company’s twice-daily formulation in 2005 as a topical NSAID for ophthalmic use after cataract surgery. The dosing regimen consisted of 2 drops per day (1 drop two times per day) for 2 weeks after surgery (patients received a total of 28 drops). The company discontinued shipments of the twice-daily formulation Feb. 28, 2011.
A little more than 4 months before that date, on Oct. 16, 2010, the FDA approved ISTA's supplemental new drug application for once-daily bromfenac sodium ophthalmic solution 0.09%. This approval changed the labeling for the drug to be dosed at 1 drop the day before surgery, 1 drop on the day of surgery, and 1 drop once a day for the next 2 weeks (patients receive a total of 16 drops).
The new labeling was based on clinical investigations conducted by ISTA that demonstrated once-daily dosing as the lowest effective dose of bromfenac 0.09% for use in connection with cataract surgery. In addition, the FDA granted the product a name change to emphasize the once-daily dosing and granted the product 3 years of exclusivity for the clinical studies that were required for the change in dosing.