Time: 7:53

Opthea meets with European regulators

Opthea (ASX:OPT), a developer of novel biologic therapies for the treatment of eye diseases, says it has concluded positive European scientific advice meetings with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Sweden’s Medical Products Agency (MPA) for the clinical development program of OPT-302, its novel VEGF-C/D ‘Trap’ therapy for the treatment of wet age-related macular degeneration (wet AMD).

The company says it sought advice from the MHRA and MPA based on their ophthalmology experience, including assessments of marketing authorisation applications for approved antiVEGF-A therapies.

“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 (EU),” said CEO and managing director Dr Megan Baldwin.

“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 VEGFA inhibitors.”

Opthea confirmed it is progressing plans to initiate a phase 2B trial in wet AMD patients later this year.

The trial will be a dose-ranging, multi-centre, randomised, parallel group, double-masked, sham-controlled study in treatment naïve patients with wet AMD. The trial will comprise three treatment groups and will investigate the clinical efficacy and safety of intravitreal OPT-302, administered monthly at two dose levels in combination with the selective VEGF-A inhibitor Lucentis (0.5 mg), compared to monthly Lucentis alone.

The primary endpoint of efficacy for the proposed Phase 2B study 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.