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展望Therapeutics获得FDA审查接受对AMD的湿治疗

2025-04-08 22:42

  • Outlook Therapeutics (NASDAQ:OTLK) said on Tuesday that the U.S. FDA has accepted to review ONS-5010, an ophthalmic formulation of bevacizumab, for the treatment of wet age-related macular degeneration, a common cause of blindness among the elderly.
  • Stock is up 9% in morning trade.
  • The agency has acknowledged receipt of the resubmission of the Biologics License Application for ONS-5010, after the company reported in January that ONS-5010 demonstrated non-inferiority to ranibizumab, sold by Roche's (OTCQX:RHHBY) Genentech unit, at week 12 in a study. 
  • FDA set a Prescription Drug User Fee Act goal date of August 27, 2025.
  • OTLK said that ONS-5010, if approved, will be branded as Lytenava in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity.
  • ONS-5010 has already received market authorization in the European Union and the United Kingdom.

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