OCU300 as a Treatment for Ocular Graft Versus Host Disease
OCU300 is a re-purposed drug with an established safety record in ocular indications being developed under the U.S. Food and Drug Agency’s 505(b)(2) regulatory pathway. In an exploratory observational study, OCU300 was found to improve symptoms in approximately of 90% patients with ocular graft versus host disease (GVHD). These findings need to be confirmed in a controlled prospective study using objective end points. Currently there is no treatment indicated for ocular GVHD.
Ocular GVHD is a common complication that occurs in patients who have undergone allogenic hematological stem cell transplantation (allo-SCT), or bone marrow transplants. Ocular GVHD develops in approximately 40 percent to 60 percent of patients following allo-SCT and its most common clinical manifestations include keratoconjunctivitis sicca and cicatricial conjunctivitis, which combine to leave patients with dry, tearless eyes, vision issues, and potential ocular scarring. Ocular GVHD may lead to severe ocular surface disease, which can significantly diminish quality of life and restrict daily activities.