Opthea (ASX:OPT), a late stage biopharmaceutical company developing novel biologic therapies to treat back-of-the eye diseases, has announced that the independent Data and Safety Monitoring Board (DSMB) for its ongoing Phase 2b study of OPT-302 in wet age-related macular degeneration (wet AMD) patients has completed the first, pre-planned safety review and has unanimously recommended that the trial continue without modification.
“We are encouraged by the outcomes of this safety review by the independent DSMB who did not identify any safety concerns in wet AMD patients administered OPT-302 in combination with Lucentis,” said Dr Megan Baldwin, CEO and managing director of Opthea. “The outcomes of this first DSMB interim review of the ongoing Phase 2b study are consistent with the favourable safety and tolerability profile observed in our Phase 1/2a clinical trial with OPT-302 in 51 wet AMD patients.”
A DSMB is a committee of independent clinical research experts who review patient safety data in ongoing clinical trials. The company said, following the completion of the first interim DSMB meeting for the study, the committee plans to meet every six months until all study participants have completed the trial.
Opthea’s double-masked Phase 2b clinical study is designed to investigate whether the addition of OPT-302 to Novartis' PBS-listed Lucentis (ranibizumab) therapy over a six-month period improves clinical outcomes, including visual acuity, in wet AMD patients.
All patients enrolled in the study are newly diagnosed, treatment-naïve patients who have not received prior therapy for wet AMD.
“Patient enrolment into the Phase 2b clinical trial is ongoing in the US, Europe and Israel. We continue to be very pleased with the rate of patient participation in this important study which reflects the need for new combination therapies to improve clinical outcomes for patients, many of whom experience sub-optimal gains in visual acuity despite ongoing and regular treatment with standard-of-care VEGF-A inhibitors,” added Dr Baldwin.
The company said it remains on-track to report primary data from the study in early 2020.