Opthea Ltd (ASX:OPT) has reported positive results from a Phase 1 dose escalation study for 20 participants with the OPT-302 molecule with the standard of care Lucentis® for 20 participants.
This first-in-human clinical trial of OPT-302 therapy for wet age-related macular degeneration met safety and tolerability and hence its primary objective as a monotherapy and in combination with standard of care.
The study is being run under an Investigational New Drug program with the Food and Drug Administration (FDA) at 14 sites across the U.S.
OPT-302 is a vascular growth factor receptor or ‘trap’ molecule that blocks the activity of two proteins that cause blood vessels to grow and leak, resulting in wet AMD, leading to vision loss.
The mean age of the participants was 74.8 years divided into three OPT-302 dose level groups in combination with Lucentis and an OPT-302 monotherapy group.
Overall, 16 out of 19 patients maintained or gained vision by week 12 compared to baseline.
Specifically, no dose limiting toxicities and no treatment-related serious adverse events were observed through week 12 of the study.
The changes in visual acuity and anatomic improvements following the 3 month multiple dosing period demonstrates the clinical activity of OPT-302 in both naïve patients and prior treated patients.
Opthea is currently accruing up to 30 additional patients into the Phase 2A dose expansion study cohorts.
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