FDA Oks single-use vial of hyaluronidase

January 1, 2005

Irvine, CA-The FDA has approved the single-use vial of ISTA Pharmaceuticals' hyaluronidase injection ovine sterile solution (Vitrase) for use as a spreading agent in the dispersion and absorption of other drugs. The company said it would launch the new vial size and the larger 6,200-USP Units multi-purpose vial early in the first quarter of 2005. The larger vial was approved in May.

Irvine, CA-The FDA has approved the single-use vial of ISTA Pharmaceuticals' hyaluronidase injection ovine sterile solution (Vitrase) for use as a spreading agent in the dispersion and absorption of other drugs. The company said it would launch the new vial size and the larger 6,200-USP Units multi-purpose vial early in the first quarter of 2005. The larger vial was approved in May.

Meanwhile, ISTA Pharmaceuticals has licensed exclusive U.S. marketing rights from Senju Pharmaceuticals Co. to ecabet sodium, a prescription eye drop for the treatment of dry eye. The product, which is said to stimulate mucin secretion and improve the quality of tears, is in phase II studies in Japan. It is on the market there as an oral agent for gastric ulcers and gastritis.

ISTA already has marketing agreements with Senju for once-daily timolol (Istalol) and bromfenac sodium ophthalmic solution 0.1% (Xibrom).