Clinical stage biopharmaceutical company Opthea (ASX:OPT), which is developing biologic therapies to treat eye diseases, says it has completed patient dosing and all follow-up week 12 patient visits in the Phase 2a trial evaluating the safety and efficacy of OPT-302 administered in combination with Bayer's EYLEA (aflibercept) for the treatment of diabetic macular edema (DME).
“We are extremely grateful to have reached this clinical milestone, particularly given the current challenges presented by the COVID-19 pandemic and restricted movements of patients globally," said CEO and managing director, Dr Megan Baldwin.
"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.
"Therefore, we expect the study to report out in accordance with our timelines, pending any potential impact of government-mandated isolation procedures.”
The company said it is also planning for its Phase 3 program in wet age-related macular degeneration, including preparation of documentation for regulatory engagement in the US and Europe, and to progress its manufacturing of OPT-302 for Phase 3 clinical trials.
It said these activities are on-going and not currently impacted by the COVID-19 pandemic.
Dr Baldwin continued, “The fundamentals of our technology remain unchanged despite the global challenges we are facing with the COVID-19 pandemic. 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.
"Our thoughts are with those affected by this virus globally and we will continue to assess the impact of government policies and the recommendations of health authorities both domestically and internationally on our programs and will update shareholders as appropriate.”