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  • Regulatory NewsRegulatory News

    Alcon’s CyPass Market Withdrawal Escalates to FDA Class I Recall

    A US Food and Drug Administration (FDA) safety communication was escalated to a Class I recall for Alcon’s CyPass micro-stent systems over risk of eye damage in implanted patients.   FDA’s safety communication was issued last month based on a preliminary review of five-year post-surgery data from the COMPASS-XT study conducted by Alcon, the eye care division of Novartis. A second FDA safety alert involving the CyPass device was issued Wednesday in conjunction w...
  • Regulatory NewsRegulatory News

    CDRH Launches New 510(k) Pilot Program for Certain Ophthalmic Devices

    The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new voluntary 510(k) pilot program to develop and refine individual premarket testing recommendations for ophthalmic optical coherence tomography (OCT) devices.   Under the pilot program, the individual premarket testing recommendations CDRH staff will seek to refine in collaboration with participating manufacturers are aimed at enabling greater consistency in 510(k) s...
  • Regulatory NewsRegulatory News

    FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition

    The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis. In 2008, FDA approved Sirion Therapeutics' Durezol, a corticosteroid, to treat inflammation and pain associated with ocular surgery. Two years later, Alcon acquired the rights to Durezol from S...
  • FDA Tightens Limits on Endotoxin Testing for Some Eye Surgery Devices

    The US Food and Drug Administration (FDA) is warning manufacturers of intraocular ophthalmic devices that they must do more to reduce the risk of their devices being contaminated with the endotoxins which cause Toxic Anterior Segment Syndrome (TASS) outbreaks. The warning came in the form of a new draft guidance document, Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices , released on 17 April 2014. The guidance notes that national outbr...