Opthea (ASX:OPT), an Australian clinical-stage biopharmaceutical company developing a novel therapy to treat retinal diseases, says it has finalised the protocol study designs and key start-up activities in readiness for the initiation of the phase three ShORe and COAST pivotal clinical trials of OPT-302 in wet age-related macular degeneration (AMD).
The company said the finalisation of the trial protocols follows consultations with regulators in the US and Europe as well as Key Opinion Leaders (KOLs) in wet AMD.
It said two global experts in the treatment of retinal diseases, Professor Timothy Jackson and Dr Charles Wykoff, will be the chief investigators for the ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) trials.
“The collaborative nature of our study protocol discussions with our KOLs, the FDA and EMA has been very pleasing and the constructive input received ensures that the design of the OPT-302 Phase 3 program has the potential to generate compelling and persuasive clinical data capable of satisfying regulatory requirements,” said Opthea CEO Dr Megan Baldwin.
“With the achievement of other key start-up milestones, including successful scale-up of manufacturing and fill-finish of OPT-302 drug product for use in the trials, we now excitedly look forward to initiating the pivotal Phase 3 studies that are designed to support potential marketing approval of OPT-302 for the treatment of wet AMD.”
The global, multi-centre, double-masked, sham-controlled, pivotal phase three trials will each enrol approximately 990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg of Novartis' LUCENTIS (ranibizumab) (ShORe trial) or 2.0 mg of Bayer's EYLEA (aflibercept) (COAST trial), compared to LUCENTIS or EYLEA monotherapy.
The company said the primary endpoint for both trials is the mean change in 'Best Corrected Visual Acuity' from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy.
Opthea said it on track to initiate the trials in the first quarter of calendar year 2021 and to report top-line data in the second half of 2023.