Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU200 clinical trial has reviewed safety data from the first cohort and approved continuation of dosing in the second cohort. OCU200 is a novel fusion protein consisting of tumstatin and transferrin, with the potential to treat diabetic macular edema (DME). No serious adverse events related to OCU200 have been reported to date.
The OCU200 Phase 1 clinical trial is a multicenter, open-label, dose-escalation study designed to assess drug safety via intravitreal injection across three dose cohorts. Subjects will receive two doses six weeks apart and be followed for up to six months. The successful completion of dosing in the low dose cohort with a favorable safety profile is an encouraging step forward.
There remains a considerable unmet medical need for the 30% to 40% of DME patients who do not respond to current anti-VEGF therapies. OCU200's unique mechanism of action, targeting integrin receptors, holds promise for benefiting patients with DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD). Ocugen intends to complete the Phase 1 trial in the second half of 2025.
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