- Opthea (OPT) opens patient enrolment for its Phase 3 clinical program for the treatment of wet age-related macular degeneration in the Asia-Pacific region
- OPT says the clinical trial sites build upon the progress of other international regions that are also actively recruiting patients, including the US, Canada and Europe
- The studies, named ShORe and COAST, aim to assess the change in best corrected visual acuity from baseline to week 52 using OPT‑302 combination therapy, when compared to standard of care anti‑VEGF‑A monotherapy
- Opthea closed down 0.78 per cent at $1.27 per share
Opthea (OPT) has opened patient enrolment for its Phase 3 clinical program for the treatment of wet (neovascular) age-related macular degeneration (AMD) in the Asia-Pacific region.
The clinical trial sites are said to further build upon the progress of other international regions that are also actively recruiting patients, including the US, Canada and Europe.
The studies, named ShORe and COAST, aim to assess the change in best corrected visual acuity from baseline to week 52 using OPT‑302 combination therapy, when compared to standard of care anti‑VEGF‑A monotherapy.
The ShORe and COAST studies are both double‑masked, Phase 3 registrational trials to evaluate efficacy and safety of intravitreal 2.0 mg OPT‑302 in combination with either ranibizumab or aflibercept.
“This is a significant milestone for the OPT302 development program and enables eligible patients to participate in the ShORe and COAST Phase 3 trials, which are designed based on strong scientific rationale, prior positive clinical efficacy results and extensive safety data in the wet AMD target population,” CEO and Managing Director of Opthea Dr Megan Baldwin said.
“Over the following weeks we anticipate opening sites in additional countries in the Asia Pacific region including South Korea and the Philippines.”
Opthea closed down 0.78 per cent at $1.27 per share.