Opthea (ASX:OPT), a late-stage biopharmaceutical company developing novel biologic therapies to treat back-of-the-eye diseases, says its phase 1b trial for Diabetic Macular Edema (DME) has successfully met its primary objective of demonstrating acceptable safety and tolerability.
The study is investigating dose escalation of OPT-302 administered in combination with Bayer's PBS-listed EYLEA (aflibercept) on a monthly basis for three months by ocular injection in patients with persistent central-involved DME despite prior sub-optimal responses to standard of care anti-VEGF-A therapy.
The phase 1b safety study enrolled nine patients with persistent central-involved DME and a mean age of 61.1 years.
According to the company, OPT-302 in combination with EYLEA was well tolerated at all dose levels in patients with DME. No dose-limiting toxicities were observed and the maximum tolerated dose was not reached with OPT-302.
"Furthermore, there were no treatment-related ocular or systemic adverse events and the very few ocular events noted were mild and primarily related to the intravitreal injection procedure," it said. "There were no clinically significant changes in intraocular pressure, electrocardiograms, blood pressure or other vital signs during the patient safety assessment period following dosing with OPT-302 combination therapy."
“The favourable Phase 1b safety results are an important milestone given this trial represents the first time OPT-302 has been administered in patients with DME and in combination with EYLEA,” said Dr Megan Baldwin, Opthea’s CEO and managing director.
“The encouraging safety profile of a combination OPT-302 therapy in DME builds upon our growing clinical experience from completed Phase 1/2a and ongoing Phase 2b clinical trials in wet age-related macular degeneration (wet AMD) patients who have received OPT-302 in combination with ranibizumab (LUCENTIS).”
The company said the Phase 2a dose expansion trial is now open and will enrol approximately 108 DME patients with treatment allocated in a 2:1 ratio to either OPT-302 with EYLEA, or EYLEA monotherapy.
The Phase 1b/2a trial is being run under an Investigational New Drug program with the US FDA at 20 sites across the U.S. and 6 sites in Australia.