Staff Writer

ISTA Pharmaceuticals Inc. said Friday a new drug application was submitted to the FDA by its partner, Senju Pharmaceuticals Co. Ltd., for a special formulation of timolol for treating glaucoma, which ISTA has named Istalol.

Senju, of Osaka, Japan, completed a Phase III study in the United States, although those results have not been publicly released, said ISTA President and CEO Vicente Anido.

"The work on this was done by our partner, Senju," Anido said. "They spent a lot of time and energy, and we are very pleased with their work."

ISTA holds the marketing rights to the product in the United States.

Anido said Irvine, Calif.-based ISTA is "very, very pleased" to be at this point.

"It's obviously been a roller-coaster ride for the company this year, and to be able in the last year to acquire late-stage compounds to supplement Vitrase" is very good for the company, Anido said.

Vitrase is ISTA's drug candidate for vitreous hemorrhage.

Earlier this month ISTA reported that it had secured $40 million in equity financing in addition to a $4 million bridge loan, just as the company faced the end of its cash reserves. (See BioWorld Today, Sept. 20, 2002.)

Timolol is a beta-blocking agent for treating glaucoma, and ISTA said its formulation offers advantages over currently marketed medications for the disease.

"It's once a day, where other timolols start out at twice a day," Anido said. "This is a solution and many of the leading beta blockers are gels; we think that a solution instead of a gel has major advantages."

Timolol is one of three late-stage ophthalmology compounds ISTA acquired from AcSentient Inc., of Research Triangle Park, N.C., in May. (See BioWorld Today, May 7, 2002.)

Anido said ISTA will be looking to launch the drug in late 2003 or early 2004, depending on the timing of the drug's approval by the FDA. He said ISTA will be targeting ophthalmologists in marketing the drug.

ISTA plans to build a sales force to launch not only this product, but others once they are approved; however, in the early stage of launching Istalol, Anido said, the company may use a contract sales force. For its own sales force, Anido said it will begin with a target number of salespeople totaling in the mid-20s and move to a later target of the mid-40s.

Elsewhere in ISTA's pipeline, its Vitrase was submitted to the FDA for approval, but the drug missed its primary endpoint in two pivotal Phase III studies in March. ISTA said in April that the FDA notified it that the company could still submit the NDA with visual acuity considered as the primary endpoint in the pivotal trials. (See BioWorld Today, March 27, 2002, and April 11, 2002.)

ISTA's stock (NASDAQ:ISTA) fell 12 cents Friday, or 22.4 percent, to close at 42 cents.