Opthea (ASX:OPT), a late stage biopharmaceutical company developing novel biologic therapies to treat back-of-the-eye diseases, has announced it has dosed the first patient in the phase 2a randomised, controlled clinical trial evaluating the safety and efficacy of OPT-302 in patients with persistent center-involved diabetic macular edema (DME).
The trial is a multicenter, masked study that will enrol around 108 DME patients with treatment randomised in a 2:1 ratio to either OPT-302 with Bayer's EYLEA (aflibercept), or EYLEA monotherapy administered on a monthly basis for three months.
OPT-302 is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) or ‘Trap’ molecule that blocks the activity of two proteins (VEGF-C and VEGF-D) that cause blood vessels to grow and leak. These processes contribute to the pathophysiology of retinal diseases.
The latest trial follows on from the recently completed phase 1b dose escalation safety review in DME patients.
In the phase 1b safety study, OPT-302 administered by intravitreal injection at three escalating doses (0.3, 1.0 or 2.0 mg) in combination with EYLEA was well tolerated at all dose levels.
In addition, the company said, there were no dose-limiting toxicities or treatment-related ocular or systemic adverse events. The dose of OPT-302 taken forward from the phase 1b to be used in combination with EYLEA in phase 2a was the highest dose that was tested (2 mg).
“Advancing OPT-302 combination therapy with EYLEA into the phase 2a study for the treatment of DME represents the achievement of another important milestone in the progression of our pipeline, following the continued progress of the phase 2b study of OPT-302 in combination with LUCENTIS in patients with wet AMD,” said Dr Megan Baldwin, Opthea’s CEO and managing director. “We remain focused on developing our proprietary novel anti-VEGF-C/D therapy for these expanding eye disease markets which represent a large unmet medical need.”