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Opthea progresses DME trials despite COVID-19 disruption

Results are imminent in biopharmaceutical company Opthea’s latest clinical trial evaluating the safety and efficacy of its lead drug candidate with Eylea in diabetic macular edema (DME) patients.

The Melbourne-based company is also forging ahead with its Phase 3 program in neovascular age-related macular degeneration (nAMD), including preparing documentation for regulatory engagement in the US and Europe, and to progress manufacturing OPT-302 for Phase 3 clinical trials.

The ASX-listed company has developed OPT-302, a ‘trap’ molecule that blocks the activity of two proteins that cause blood vessels to grow and leak; processes which contribute to the pathophysiology of retinal diseases.

In a statement released on 30 March, Opthea announced it has completed patient dosing and all follow-up week 12 patient visits in its Phase 2a trial evaluating the safety and efficacy of its lead drug candidate when administered with Eylea (aflibercept) to treat DME.

Opthea CEO and managing director Dr Megan Baldwin was “extremely grateful” to have reached the clinical milestone, “particularly given the current challenges presented by the COVID-19 pandemic and restricted movements of patients globally”.

“With all patients now having completed the treatment phase of the study, Opthea is now focused on data cleaning and preparation for data readout. A large proportion of the data cleaning activities have already been completed for the majority of patients enrolled in the study, and if necessary, the remaining activities may be performed remotely,” she said.

Baldwin said she expected the study report to come out in accordance with Opthea’s timelines, pending any potential impact of government mandated isolation procedures.

In addition to advancing the Phase 2a DME trial, planning continues for its Phase 3 program in nAMD, and manufacturing OPT-302 for Phase 3 clinical trials.

“These activities are on-going and not currently impacted by the COVID-19 situation,” Baldwin said.

She said Opthea’s current financial position provides sufficient scope to focus on corporate strategic objectives and clinical development activities as the COVID-19 situation continues to evolve.

“The fundamentals of our technology remain unchanged despite the global challenges we are facing with the COVID-19 pandemic,” Baldwin said.

“Now, more than ever, we are reminded of the vulnerability of our communities and the need for effective treatments to improve the health and quality of life for all individuals – a sentiment that underpins Opthea’s programs to improve vision in patients with macular degeneration and diabetic eye disease.”

She said Opthea will continue to assess the impact of government policies and the recommendations of health authorities both domestically and internationally on its programs.