Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

oGVHD

Regenerative Ocular Immunobiologics, LLC Fast Track Expanded Access This Expanded Access Policy describes the conditions under which ROI may make its investigational product - Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) - available to patients outside of a clinical trial, in accordance with U.S. FDA regulations, including section 561A of the Federal Food, Drug, and Cosmetic Act (FDCA).

Regenerative Ocular Immunobiologics, LLC (ROI) is committed to advancing innovative regenerative biologics for serious ocular conditions with high unmet medical need. The investigational product, d-MAPPS™ Ophthalmic Solution, is currently being evaluated in clinical trials under U.S. FDA Investigational New Drug (IND) #030066. Clinical trial participation remains the preferred and primary pathway for patient access. ROI has established this Expanded Access Policy in accordance with Section 561A of the FDCA to outline conditions under which d-MAPPS™ may be considered outside of a clinical trial. At this stage of development, d-MAPPS™ is not approved by the FDA. Participation in a clinical trial is the preferred mechanism for accessing this investigational treatment, as trials are designed to evaluate safety and effectiveness in a controlled setting. Certain patients with serious or immediately life-threatening conditions may not meet eligibility criteria for clinical trials and may pursue access to investigational therapies. In accordance with Section 561A of the Federal Food, Drug, and Cosmetic Act, Regenerative Ocular Immunobiologics has established the following Expanded Access (EA) policy: This Expanded Access Policy describes the conditions under which Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) may be made available to patients outside of a clinical trial, in accordance with U.S. FDA regulations. Availability * Expanded Access to d-MAPPS™ may be considered for patients with severe chronic ocular GVHD who have no satisfactory alternative treatment options and who are not eligible for ongoing clinical trials. * Expanded Access is not guaranteed and remains subject to review of patient circumstances, clinical data, and drug supply. Request Procedures Treating ophthalmologists or eye care professionals may submit Expanded Access requests to info@roiglobalsolutions.org. Requests should include relevant patient history, diagnosis, rationale for Expanded Access, and a proposed monitoring plan. Criteria for Consideration Requests will be evaluated on the following: * Seriousness of the patient's condition * Lack of satisfactory therapeutic alternatives * Ineligibility for ongoing clinical trials * Whether potential benefit justifies potential risk of the investigational product * Adequate drug supply Review and Response Timeline Regenerative Ocular Immunobiologics will acknowledge receipt of EA requests within 5 business days and will provide a decision as promptly as possible while following all FDA requirements. All requests will be reviewed in accordance with FDA regulations and company policy. Cost of Treatment ROI does not currently intend to charge patients for d-MAPPS™ provided through Expanded Access. ROI reserves the right to recover direct costs in accordance with FDA regulations should circumstances change. Policy Updates This Expanded Access Policy will be reviewed and updated as needed. The most current version will be available at: https://www.roiglobalsolutions.org/

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