Ista Pharmaceuticals Inc has received an approvable letter from the U.S. Food & Drug Administration (FDA) with respect to Ista's New Drug Application (NDA) for Vitrase (ovine hyaluronidase) for the treatment of c. In the letter, the FDA cited issues primarily related to the sufficiency of the efficacy data submitted with the NDA. The FDA requested additional analysis of the existing data and an additional confirmatory clinical study based upon that analysis. The FDA also cited issues related to the drug substance and drug product specifications. No deficiencies were cited in the FDA's letter regarding the safety data contained in the NDA.
Vicente Anido, Jr., President and Chief Executive Officer of Ista, commented, "ISTA will continue its active dialogue with the FDA to discuss the comments contained in the approvable letter and determine the next appropriate steps in the review and approval process."
Ista Pharmaceuticals is focused on saving and improving eyesight by developing proprietary therapeutic products. Ista's product candidates and programs seek to address serious diseases and conditions of the eye such as vitreous hemorrhage, diabetic retinopathy, hyphema, glaucoma and ocular pain and inflammation. Building on this pipeline, Ista's goal is to become a fully integrated specialty pharmaceutical company by developing or acquiring complementary products, either already marketed or in late-stage development.