Sign up Australia
Proactive Investors - Run By Investors For Investors

Opthea starts clinical trial for diabetic blindness treatment

OPT-302 targets the leading cause of blindness in diabetics.
Human eye
The trial will evaluate safety and efficacy of OPT-302 in U.S. patients

Opthea Ltd (ASX:OPT) has started a clinical trial for its soluble VEGFR-3 ‘trap’ molecule OPT-302 in patients with centre-involved diabetic macular edema (DME).

DME is the leading cause of blindness in diabetics and is estimated to affect over 2 million people globally.

It is characterised by retinal thickening from leaky blood vessels.

The Phase 1b/2a trial will evaluate the safety and efficacy of OPT-302 in DME patients in the U.S.

Patients being recruited

Following submission of the study protocol to the Food and Drug Administration, and ethics approval by the central Institutional Review Board, clinical trial sites have been activated with patients being recruited.

The multi-centre clinical trial in the U.S. and Australia has two parts.

Trial has two parts

First is a Phase 1b dose escalation of OPT-302 used in combination with the VEGF-A inhibitor Eylea®.

Second is a Phase 2a randomised, controlled dose expansion with treatment allocated in a 2:1 ratio to either OPT-302 with Eylea®, or Eylea® monotherapy.

The trial will enrol circa 117 patients with persistent central involved DME despite prior anti-VEGF-A therapy with each patient dosed on a monthly basis for three months via intravitreal injection.

Clinical program expanded

This marks the expansion of the clinical development program for OPT-302 into a second ocular indication and targets a severe complication of diabetes.

Primary analysis of data from the Phase 1b/2a clinical trial is anticipated in the first half of 2019.

Opthea’s program includes a Phase 2b clinical trial in wet age-related macular degeneration, which is underway.

These trials will enable Opthea to more broadly explore the therapeutic potential of OPT-302.

Opthea is a late stage biopharmaceutical company developing novel biologic therapies to treat back-of-the-eye diseases.

View full OPT profile View Profile

Opthea Ltd Timeline

Related Articles

June 21 2018
Genedrive has signed sales agreement with Sysmex Corporation for the distribution of the HCV ID to EMEA and Asia Pacific and with Mumbai- based ARKRAY to distribute the kit in India
July 26 2018
Under former chief executive Peter George and his successor Shaun Chilton, Clinigen has been transformed via a series of well-judged, quickly integrated and cash generative acquisitions
August 21 2018
The company aims to revolutionise the HPA production process, eschewing the laborious bauxite-sourced method.

No investment advice

The information on this Site is of a general nature only. It does not take your specific needs or circumstances into consideration, so you should look at your own financial position, objectives and requirements and seek financial advice before making any financial decisions. You acknowledge and understand that neither the Company, its related bodies corporate, the information providers or their affiliates will advise you personally about the nature, potential value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter. You should read our FSG and any other relevant disclosure documents and if necessary seek persona advice prior to making any investment decision.

You understand and agree that no Content (as defined below) published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person.

You understand that in certain circumstances the Company, its related bodies corporate, the information providers or their affiliates may have received, or be entitled to receive, financial or other consideration in connection with promoting, and providing information about, certain entities on the Site and in communications otherwise provided to you.

You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate. From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.

Before you act on any general advice we provide, please consider whether it is appropriate for your personal circumstances.

© Proactive Investors 2018

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