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).
Age ≥18 years.
Willing and able to provide written informed consent.
Willing and able to comply with study assessments for the full duration of the study.
Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
History of Rheumatoid Arthritis, Lupus, Scleroderma. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).
Ocular or periocular malignancy.
Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
Any history of topical tacrolimus use (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).