Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.

Inclusion Criteria: * Age 18 years or older. * Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation. * Investigator determines the participant is medically stable and appropriate for study participation. * Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline. * UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline. * Modified Oxford Corneal Staining Score of at least 1 in at least one eye. * Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments. * Written informed consent obtained before study procedures. * Willing and able to comply with study visits, study treatment, and protocol requirements. * Background therapies stable for at least 30 days before Baseline. Exclusion Criteria: * Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment. * Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis. * Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study. * Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline. * Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease. * Participation in another investigational study within 30 days before Screening or concurrent enrollment. * Pregnancy or breastfeeding.