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

A Randomized, Double-Masked, Vehicle-Controlled, Adequate and Well-Controlled Pivotal Study With Co-Primary Endpoints to Evaluate the Safety and Efficacy of d-MAPPS™ Ophthalmic Solution in Subjects 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.