Sign up Australia
Proactive Investors - Run By Investors For Investors

Opthea receives positive feedback for macular degeneration therapy

Opthea has concluded scientific advice meetings in the UK and Sweden.
Opthea receives positive feedback for macular degeneration therapy
Phase 2B trial in patients to commence in 2H 2017

Opthea (ASX:OPT) has received positive feedback from European regulatory agencies for the clinical development of OPT-302 for the treatment of wet age-related macular degeneration (wet AMD).

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.



Register here to be notified of future OPT Company articles
View full OPT profile

Opthea Timeline

Related Articles

hepatitisC.jpg
March 28 2017
Regulatory sign-off will fire the starting pistol on the commercial launch in Europe
stylised picture with web icons meant to denote a web search
May 11 2016
Searchbolt, the business being bought, was spun-off from ETX when the latter was listed on stock market in 2007
Novogen: Access latest PPT from Proactive's CEO Sessions
April 13 2017
Dr James Garner talked clinical-stage programs with investors.

© Proactive Investors 2017

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use