Opthea Ltd (ASX:OPT) has met the primary safety endpoint in a Phase 1 dose escalation of its OPT-302 treatment for wet age-related macular degeneration administered by intravitreal injection in combination with Lucentis in a clinical trial in 20 patients at sites in 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 age-related macular degeneration (wet AMD), leading to vision loss.
The dose escalation trial is investigating OPT-302 administered either alone or in combination with another drug Lucentis, on a monthly basis for three months by ocular (eye) injection.
The study is being run under an Investigational New Drug (IND) program with the Food and Drug Administration (FDA) at 14 sites across the U.S.
The 28 day safety assessment period has now been completed for all 20 patients in the Phase 1 dose escalation trial.
OPT-302 administered by injection into the eyes in combination with Lucentis was found to be safe and well tolerated at all dose levels for the 20 patients with wet AMD.
There were no signs of infection inside the eye, or clinically significant changes in vital signs during the safety assessment period.
With the 28 day safety assessment period complete for the patients in the Phase 1 dose escalation trial, patient recruitment for the randomised dose expansion Phase 2A study will now commence.
The primary analysis data from the Phase 2A study, which will enrol an additional 30 patients, is expected by the end of 2016.
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