OPT-302 is a vascular growth factor receptor or ‘trap’ molecule that blocks the activity of two proteins that cause blood vessels to grow and leak, resulting in wet AMD, leading to vision loss.
Opthea has concluded positive scientific advice meetings with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Sweden’s Medical Products Agency (MPA).
The company sought advice from the MHRA and MPA based on their extensive ophthalmology experience, including assessments of marketing authorisation applications for approved therapies.
The valuable discussions and advice on Opthea’s clinical program is expected to help advance the development of OPT-302 as a combination therapy for patients suffering from wet AMD.
Opthea is progressing plans to initiate a Phase 2B randomised, double-masked, sham-controlled trial in patients with wet AMD in 2H 2017.
The trial 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 the proposed Phase 2B study is the mean change from baseline in visual acuity (sharpness).
Further details about the trial design will be announced in 2H 2017 following reporting of data from Opthea’s ongoing Phase 1/2A clinical trial in 51 patients with wet AMD by the end of March 2017.
Opthea’s share price has more than doubled during the past one year, last trading at $0.95.
The company had a cash balance of circa $13.1 million as at 31 December 2016.