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Vitrase ISTA Pharmaceuticals.

Marcin Czajka1, Sharon Fekrat

  • 1Vitreoretinal Surgical Service, Duke University Eye Center, PO Box 3802, Durham, NC 27710, USA. Czajk001@mc.duke.edu

Idrugs : the Investigational Drugs Journal
|November 27, 2004
PubMed
Summary
This summary is machine-generated.

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Vitrase is a potential treatment for vitreous hemorrhage and diabetic retinopathy. It received approval in Mexico and Fast-Track designation from the FDA for vitreous hemorrhage.

Area of Science:

  • Ophthalmology
  • Pharmacology

Background:

  • Vitrase is a pharmaceutical agent developed by ISTA Pharmaceuticals Inc. and Otsuka Pharmaceutical.
  • It is being investigated for the treatment of vitreous hemorrhage and diabetic retinopathy.

Purpose of the Study:

  • To summarize the development status and regulatory progress of Vitrase for ophthalmic conditions.

Main Methods:

  • Review of regulatory filings and approvals.
  • Analysis of development timelines and market projections.

Main Results:

  • Vitrase received approval in Mexico in November 1998 for vitreous hemorrhage.
  • The U.S. Food and Drug Administration (FDA) granted Fast-Track designation in October 1998 for vitreous hemorrhage.

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  • Initial sections of the New Drug Application (NDA) were filed in January 2002, with clinical sections planned for submission.

    • Conclusions:

    • Vitrase has demonstrated progress through regulatory pathways for vitreous hemorrhage.
    • Market launch was anticipated in early 2003 with significant sales projections.