• COVID-19
  • Biosimilars
  • Cataract Therapeutics
  • DME
  • Gene Therapy
  • Workplace
  • Ptosis
  • Optic Relief
  • Imaging
  • Geographic Atrophy
  • AMD
  • Presbyopia
  • Ocular Surface Disease
  • Practice Management
  • Pediatrics
  • Surgery
  • Therapeutics
  • Optometry
  • Retina
  • Cataract
  • Pharmacy
  • IOL
  • Dry Eye
  • Understanding Antibiotic Resistance
  • Refractive
  • Cornea
  • Glaucoma
  • OCT
  • Ocular Allergy
  • Clinical Diagnosis
  • Technology

FDA accepts Sirion NDA, license acquisition

Article

The FDA has accepted Sirion Therapeutics' new drug application (NDA) for difluprednate ophthalmic emulsion 0.05% (Durezol) and has granted it priority review, the Tampa, FL-based company has announced.

Rockville, MD-The FDA has accepted Sirion Therapeutics' new drug application (NDA) for difluprednate ophthalmic emulsion 0.05% (Durezol) and has granted it priority review, the Tampa, FL-based company has announced.

The steroid has been tested as a twice-daily treatment for postoperative ocular inflammation. Under the priority review process, the start date for the 6-month review is the date of receipt of the NDA. The FDA has issued an action date of June 26.

Data from two phase III clinical studies of difluprednate will be presented at the annual meeting of the American Society of Cataract and Refractive Surgery next month in Chicago.

Under the terms of this licensing agreement, Sirion will have the rights to manufacture, sell, and distribute norketotifen for ocular use either alone or in combination with other drugs. Clinical trials of the drug are expected to begin in early 2009.

"We are very excited about the medical and market potential of the norketotifen molecule," said Roger Vogel, MD, chief medical officer of Sirion.

Related Videos
Paul Badawi, co-founder and CEO of Sight Sciences, chats with Neda Shamie, MD, about what drives him
© 2024 MJH Life Sciences

All rights reserved.