ISTA Pharmaceuticals Inc. expects to enter the $1.1 billion U.S. glaucoma market sometime early next year with its once-daily liquid treatment called Istalol.
High hopes for the future came Monday morning when the Irvine, Calif.-based company released a statement saying the FDA issued an approvable letter for Istalol, a formulation of the beta-blocker timolol developed by Senju Pharmaceutical Co. Ltd., of Osaka, Japan.
ISTA's stock (NASDAQ:ISTA) closed Monday at $7.80, up $1.55, or 24.8 percent.
"Timolol is a well-known product in the U.S. used to treat glaucoma, but this is the first liquid form that is truly used once a day," Vicente Anido, ISTA's president and CEO, told BioWorld Today. "Most other forms of timolol are gel. You put them on your eye and you get blurry vision. We think one drop per day is a major advantage."
He said FDA action is being held up due to questions surrounding manufacturing methods and controls. The company is qualifying an alternative manufacturer, a Bausch & Lomb contractor located in Tampa, Fla.
The FDA has not requested additional clinical trials.
"We've come a long way over the last 12 months, going from having no products at the FDA to now having two approvable letters and a third product that is in its final Phase III in the U.S.," Anido said. "This approvable letter is just one additional step on a road to becoming a fully integrated specialty pharmaceutical company. We hope to launch sometime in the early part of 2004."
Istalol is one of three late-stage ophthalmology compounds ISTA acquired from AcSentient Inc., of Research Triangle Park, N.C., in May 2002. The others are bromfenac, a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation, and Caprogel (aminocaproic acid), a compound to treat hyphema. (See BioWorld Today, May 7, 2002.)
Through the acquisition, ISTA also developed a relationship with Senju, which had initially sold rights to Istalol and bromfenac to AcSentient. By the time ISTA got in the game, Senju was nearly finished with clinical trials for the Istalol new drug application. Therefore, ISTA allowed Senju to follow through and file with the NDA. (See BioWorld Today, Sept. 30, 2002.)
ISTA acquired U.S. rights to Istalol and intends to market the liquid glaucoma treatment there. Senju would receive royalties.
Meanwhile, ISTA continues working with the FDA to get Vitrase to market. Vitrase is a proprietary formulation of ovine hyaluronidase used to treat vitreous hemorrhage.
In an 8-4 vote in March, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee said the company's data did not support efficacy, but in a 7-5 vote, the committee said Vitrase's benefits outweigh its risks. (See BioWorld Today, March 18, 2003.)
The FDA issued an approvable letter in April for Vitrase, saying additional data analysis or confirmatory trials may be necessary. (See BioWorld Today, April 8, 2003.)
Anido said ISTA and the agency are continuing discussions about the best course of action to take with Vitrase.
Elsewhere in the pipeline, ISTA hopes to file an NDA for bromfenac in early 2004.
The company's other product, Caprogel, a gel form of aminocaproic acid used to treat hyphema (bleeding into the anterior chamber, or front of the eye) is in a feasability study.