Expanded Access Policy

Policy Overview

OKYO Pharma is committed to developing investigational therapies through carefully conducted clinical trials so that their safety and effectiveness can be properly evaluated and regulatory approval can be obtained.

Expanded Access Programs

In limited circumstances, OKYO Pharma may consider requests for expanded access (sometimes referred to as “compassionate use”) to investigational products for patients with serious or life-threatening conditions who have no satisfactory alternative therapies and who are unable to participate in an ongoing clinical trial.

Participation in clinical trials is the primary method through which patients may access investigational therapies being developed by OKYO Pharma. Expanded access may be considered only in limited circumstances for patients who are unable to participate in an ongoing clinical trial.

FDA Expanded Access Policy for OKYO Pharma’s Urcosimod

Requests for expanded access must be made by the patient’s treating physician. OKYO Pharma is only able to review and respond to requests received from licensed physicians. Patients or caregivers seeking access to an investigational product should discuss potential treatment options with their physician, who can determine whether submitting a request to OKYO Pharma may be appropriate.

Each request will be evaluated on a case-by-case basis. OKYO Pharma may determine that expanded access is not appropriate based on factors such as patient safety, regulatory considerations, product supply, or the potential impact on ongoing clinical development. Due to the need to focus available resources on ongoing clinical development, expanded access may not be available at all stages of development.

If OKYO Pharma determines that a request may be appropriate to pursue, the treating physician will be responsible for obtaining any required regulatory and ethics approvals, including authorization from local regulatory authorities (e.g., FDA) and approval from an IRB/Ethics Committee, as applicable.

Physicians who wish to submit an expanded access request may contact OKYO Pharma at: expandedaccess@okyopharma.com.

OKYO Pharma will review requests and respond as promptly as practicable; however, expanded access cannot be guaranteed in any particular circumstance.
Nothing in this policy should be interpreted as a guarantee that OKYO Pharma will provide access to an investigational product under expanded access or any other pathway, including the federal Right to Try Act.