Expanded Access Policy Statement

This Expanded Access Policy Statement is published in accordance with Section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide information about our policy on making our investigational drugs available to patients outside of clinical trials.

Policy Overview

OKYO Pharma is committed to developing safe and effective treatments for patients with Neuropathic Corneal Pain. Our primary goal is to make our investigational treatments widely available to patients as quickly as possible through clinical trials and regulatory approval.

Expanded Access Programs

Expanded Access (sometimes called “compassionate use”) refers to the use of an investigational drug outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial or otherwise do not have access to investigational drugs through participation in clinical trials.

Considerations for Expanded Access Requests

OKYO Pharma will consider requests for expanded access to our investigational products based on the following criteria:

 

  1. Patient Eligibility: The patient must have a serious or life-threatening condition and have exhausted all available treatment options, including clinical trials.
  2. Risk-Benefit Assessment: The potential benefit to the patient must justify the potential risks of the investigational drug, and those risks must not be unreasonable in the context of the disease being treated.
  3. Clinical Development Impact: Providing the investigational drug for expanded access must not interfere with clinical trials that could support the drug’s development or marketing approval.
  4. Regulatory Compliance: All applicable regulatory and ethical requirements must be met, including FDA and Institutional Review Board (IRB) approvals.
  5. Available Supply: Sufficient quantities of the investigational drug must be available for both ongoing and planned clinical trials and expanded access use.

Request Process

Healthcare providers seeking expanded access to OKYO Pharma’s investigational products on behalf of their patients should contact our Expanded Access Program at:

Email: expandedaccess@okyopharma.com

Requests should include:

  • Patient’s diagnosis and disease status
  • Treatment history
  • Rationale for seeking expanded access
  • Proposed treatment plan

Response Timeline

OKYO Pharma will acknowledge receipt of expanded access requests within 5 business days and will make every effort to provide a decision within 14 business days of receiving a complete request with all necessary information.

Additional Information

Further information about our ongoing clinical trials can be found at ClinicalTrials.gov by searching for OKYO Pharma or the specific investigational product (urcosimod).

Policy Updates

This Expanded Access Policy will be reviewed and updated as necessary. Updates to this policy will be posted on our company website at www.okyopharma.com.

Disclaimer

The existence of this expanded access policy does not guarantee that expanded access to an investigational product will be provided to a patient. OKYO Pharma reserves the right to modify this policy at any time.