Australian biotech positive after European meetings

Also known as a ‘trap’ molecule, OPT-302 blocks the activity of two proteins that cause blood vessels to grow and leak in the eye and is designed to treat wet age-related macular degeneration (wet AMD).After meetings with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Sweden’s Medical Products Agency (MPA), Opthea managent is progressing plans to initiate a Phase 2B trial in the second half of 2017.The Melbourne-based company had sought advice from the MHRA and MPA based on its extensive ophthalmology experience, including assessments of marketing authorisation applications for approved anti-VEGF-A therapies.“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,” Dr Megan Baldwin, CEO and managing director of Opthea said.“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.”The Phase 2B study, planned for the second half of 2017, will be a randomised, double-masked, sham-controlled trial in patients with wet AMD. It will comprise three treatment groups and will investigate the clinical efficacy and safety of intravitreal OPT-302 in combination with Lucentis, compared to 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.The ASX listed company’s share price has more than doubled in the past year and at the time of publication was trading at AU$0.91.