Opthea (ASX:OPT) said today that it received positive feedback from meetings with the U.K.’s Medicines and Healthcare Products Regulatory Agency and Sweden’s Medical Products Agency over its OPT-302 therapy for the treatment of wet age-related macular degeneration.
The Australia-based company’s OPT-302 therapy consists of a soluble form of vascular endothelial growth factor receptor 3 that blocks the activity of 2 proteins that cause blood vessels to grow and leak. It is being evaluated in a phase 1/2 clinical trial in patients with wet AMD as a monotherapy and with ranibizumab, delivered as monthly intravitreal injections.
“We appreciate the scientific advice received from two key European regulatory agencies in support of Opthea’s strategy to conduct our planned Phase 2B wet AMD clinical trial with OPT-302 in the European Union,” managing director & CEO Dr. Megan Baldwin said in prepared remarks. “The valuable discussions and advice on our clinical program will help advance the development of OPT-302 as a combination therapy for patients suffering from wet AMD.”
“OPT-302 blocks signals that cause blood vessels in the back of the eye to grow and leak, and that may be associated with resistance to existing treatments for wet AMD. We are excited about the potential of OPT-302 to help improve clinical outcomes in patients suffering from this disease, many of whom experience a sub-optimal response despite ongoing therapy with selective VEGF-A inhibitors.”
Opthea plans to initiate a phase IIb trial in the 2nd half of this year, following formal regulatory and scientific advice meetings with agencies in the U.S., E.U., U.K. and Sweden.
The phase IIb study will be a dose-ranging, sham-controlled study in patients with wet AMD, according to Opthea. The company said the study will be composed of 3 treatment groups to evaluate the efficacy and safety of intravitreal OPT-302 at 2 dose levels administered monthly in combination with Lucentis, compared to Lucentis alone.
The study’s primary endpoint is the mean change from baseline in visual acuity, while secondary efficacy endpoints include anatomic changes in wet AMD lesion composition using spectral domain optical coherence tomography imaging, Opthea said.