ISTA Pharmaceuticals Inc. received FDA approval for its third product in a year, this time for Xibrom to treat ocular inflammation following cataract surgery.
The Irvine, Calif.-based company expects to launch Xibrom (bromfenac ophthalmic solution) 0.09 percent during the second quarter after building up a 70-person sales force and securing commercial quantities from its manufacturer.
"We're treating this like it's the biggest launch of our career because it is," said Vicente Anido, ISTA president and CEO, in a conference call on Monday. "We think this will make the company."
Xibrom will compete with other non-steroidal drugs and low- to mid-potency steroids that are used topically. The U.S. ophthalmic anti-inflammatory market is about $250 million a year, and consists of about 2.6 million people who have undergone some sort of ocular surgery, such as cataract surgery.
ISTA's product is the first twice-daily non-steroidal anti-inflammatory solution approved in the U.S. and offers major advantages over existing products, Anido said.
"Every product that is used topically today, whether steroids or non-steroidals, are dosed four times a day. And ours is dosed twice a day," he told BioWorld Today. "The steroids are typically shown to cause some level of spiking of intraocular pressure, and, in our case, we have zero impact on IOP."
The lead product in the market is Allergan Inc.'s Acular (ketorolac tromethamine), which appears to cause severe irritation in up to 40 percent of patients that use the eye drops. Xibrom, on the other hand, causes that irritation in only 2 percent to 7 percent of patients.
It's too soon to decide on pricing for the product, Anido said.
"Needless to say that with the benefits over products, such as Acular, we expect it will be priced at a premium," he said.
Xibrom also will compete with Bausch & Lomb Pharmaceuticals Inc.'s Lotemax (loteprednol etabonate), and generic versions of prednisolone acetate.
ISTA gained U.S. marketing rights for Xibrom in May 2002 through its acquisition of AcSentient Inc., of Research Triangle Park, N.C., and under a license from Senju Pharmaceuticals Co. Ltd. Osaka, Japan-based Senju has marketed the product in Japan since 2000. ISTA completed two pivotal Phase III trials in the U.S. involving 527 patients, which demonstrated statistical significance in the complete absence of ocular inflammation as early as the third day following treatment, compared to patients who received placebo. ISTA filed the NDA in May. (See BioWorld Today, May 26, 2004.)
ISTA's two other approved products are ISTAlol and Vitrase. ISTAlol, which received approval in June, is a once-daily topical solution of timolol. It also was licensed from Senju and is indicated for glaucoma. Vitrase (hyaluronidase for injection; lyophilized ovine) is a spreading agent used to facilitate the dispersion and absorption of other drugs. It was approved last May. (See BioWorld Today, May 7, 2004.)
In September, ISTA reacquired all rights to market and sell Vitrase for all uses in the U.S. and many other worldwide markets after revising a four-year-old agreement with partner Allergan, of Irvine, Calif.,
Anido said 70 people should be sufficient to market all three of ISTA's products.
"There's only 10,000 prescribers of ophthalmology products that write the bulk of the prescriptions," he said. "That allows us to get a pretty good reach."
ISTA also intends to add a couple of late-stage products to its pipeline this year. And the company recently filed an investigational new drug application to start a Phase II trial year for ecabet sodium in dry-eye syndrome. The company in-licensed rights to the product from Senju in November. (See BioWorld Today, Nov. 19, 2004.)
"We're hoping to have results of that Phase II by the end of the year," Anido said.
The company's stock (NASDAQ:ISTA) fell 17 cents on Monday to close at $9.67.