ISTA Pharmaceuticals Inc. said the FDA plans to complete its review of ISTA's new drug application for Vitrase as a spreading agent by May 5, a 90-day extension on the original action date as required by the federal government under the Prescription Drug User Fee Act.
The FDA said the extension would allow "full review of the submission," including the firm's amendment to the NDA submitted late last year.
As a spreading agent, Vitrase, a formulation of purified ovine hyaluronidase, would facilitate the dispersion and absorption of other drugs. The agency granted priority review status, requiring a six-month review, in that indication. (See BioWorld Today, Aug. 6, 2003.)
Meanwhile, ISTA, of Irvine, Calif., continues to await a decision to launch Vitrase as a single injection to the eye for vitreous hemorrhage, the subject of the firm's first NDA for the product.
If approved as a spreading agent, the firm would like the FDA to allow it to provide directions for reconstitution of Vitrase for potential treatment applications to the back of the eye. In that case, physicians could use it off label for vitreous hemorrhage, regardless of the FDA's decision.
Last April, the FDA issued an approvable letter on the hemorrhage indication, asking ISTA to further analyze existing data and possibly conduct a confirmatory trial. (See BioWorld Today, April 8, 2003.)