OPT-302 has shown to be safe and well-tolerated as a monotherapy and in combination with Lucentis in a Phase 1 dose escalation clinical trial in 20 patients with wet age-related macular degeneration at 14 sites across the United States.
The dose escalation trial is investigating OPT-302 administered either alone or in combination with Lucentis on a monthly basis for three months by ocular injection.
The novel VEGF-C/D ‘Trap’ therapy for wet age related macular degeneration has been developed by the Melbourne-based company Opthea Limited. The 28-day safety assessment period was completed for all 20 patients in the Phase 1 dose escalation trial. OPT-302 was administered by intravitreal injection as a monotherapy (2.0mg) or at three escalating doses (0.3, 1.0 or 2.0mg) in combination with Lucentis (0.5mg). The company reported it was safe and well tolerated at all dose levels in 20 patients with wet AMD who were either treatment naïve or previously treated with standard of care.
Dr. Megan Baldwin, CEO and Managing Director of Opthea, said the results were very encouraging. “Meeting the primary objective of the Phase 1 study by demonstrating that intravitreally administered OPT-302 is safe and well-tolerated at all dose levels tested in combination with Lucentis is a major milestone,” she said.
Longer-term patient outcomes and secondary measures in clinical activity from the Phase 1 dose escalation study will be reported in the third quarter of 2016 when all 20 patients have completed dosing for three months.