Vitrase ISTA Pharmaceuticals.
Vitrase is under development by ISTA Pharmaceuticals Inc (formerly Advanced Corneal Systems, ACS) and Otsuka Pharmaceutical (in Japan) for the potential treatment of vitreous hemorrhage and diabetic retinopathy. In November 1998, it was approved in Mexico for the clearing of vitreous hemorrhage [305542]. In October 1998, Vitrase was designated a Fast-Track product for the vitreous hemorrhage indication by the FDA [303024], [307576]. The initial section of an NDA was filed in January 2002, which comprised the non-clinical pharmacology and toxicology sections [434925]. In April 2002, following discussions with the FDA, ISTA reported that it would be proceeding with the preparation and submission of the clinical and other required sections of the NDA for Vitrase for the treatment of vitreous hemorrhage [447148]. In February 2002, analysts at CIBC World Markets Corp predicted Vitrase would be launched in early 2003, with worldwide sales reaching 200 million dollars within 5 years [444945].
Czajka
Marcin
M
Vitreoretinal Surgical Service, Duke University Eye Center, PO Box 3802, Durham, NC 27710, USA. Czajk001@mc.duke.edu
Fekrat
Sharon
S