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Expanded Access Policy

Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug on an expanded access basis. The following is Aurion Biotech’s expanded access policy for its drugs that are intended to treat serious diseases:

  1. Contact Information. Aurion Biotech is not making its unapproved drugs available on an expanded access basis at this time. If you have any questions about Aurion Biotech’s expanded access policy, please contact [email protected].
  2. Request Procedures. Aurion Biotech is not making its unapproved drugs available on an expanded access basis at this time.
  3. General Criteria. Aurion Biotech is not making its unapproved drugs available on an expanded access basis at this time. In the event that Aurion Biotech decides to consider expanded access requests for Aurion Biotech investigational drugs in the future, the company will evaluate and respond to each expanded access request on a case-by-case basis.
  4. Anticipated Timing. Aurion Biotech anticipates acknowledging receipt of any expanded access questions or requests within tenbusiness days of receipt. As noted above, Aurion Biotech is not making its unapproved drugs available on an expanded access basis at this time.
  5. Clinicaltrials.gov Hyperlink. Aurion Biotech is not currently making its unapproved drugs available for expanded access use. In the event that Aurion Biotech decides to make its products available on an expanded access basis, this policy will be updated with the relevant expanded access record(s) on clinicaltrials.gov after such records become active.

As authorized by the 21st Century Cures Act, Aurion Biotech may revise this expanded access policy at any time. Additionally, the posting of this policy by Aurion Biotech shall not serve as a guarantee of access to any specific investigational drug by any individual patient.