Melbourne-based biopharmaceutical company Opthea has opened clinical trial sites in Australia, including in East Melbourne and Rowville, for patients to enrol in two Phase 3 trials in neovascular age-related macular degeneration (nAMD).
The ASX and Nasdaq-listed company, which is developing novel therapies to treat highly prevalent and progressive retinal diseases, announced in October that the first clinical trial sites in the Asia-Pacific region are now open for patient enrolment to receive its first-in-class VEGF-C/D ‘trap’ inhibitor called OPT-302 for the treatment of nAMD.
Known as ShORe (an acronym for study of OPT-302 in combination with ranibizumab) and COAST (combination OPT-302 with aflibercept study), both Phase 3 trials will each enrol about 990 treatment-naïve patients globally.
Opthea said the clinical trial sites in Australia further build upon the progress of other international regions including the US, Canada and Europe that are also actively recruiting patients.
Dr Megan Baldwin, Opthea CEO and managing director, said opening enrolment in the Asia-Pacific region is a significant milestone for the OPT-302 development program.
“[It] 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,” she said.
“Over the following weeks we anticipate opening sites in additional countries in the Asia Pacific region including South Korea and the Philippines.”
Opthea’s ShORe and COAST studies are both double‑masked, sham‑controlled Phase 3 registrational trials to evaluate efficacy and safety of intravitreal 2.0 mg OPT‑302 in combination with either 0.5 mg ranibizumab (Lucentis), or 2.0 mg aflibercept (Eylea) respectively.
The company said the primary endpoint of the studies is the mean change in best corrected visual acuity from baseline to week 52 for OPT‑302 combination therapy compared to standard of care anti‑VEGF‑A monotherapy.
The top-line results are anticipated in the second half of 2023. Following completion of the primary efficacy phase, Opthea plans to file Biologics License and Marketing Authorisation Applications with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) respectively.
Recently, the FDA granted Fast Track status for OPT-302, in combination with anti-VEGF-A therapy for the treatment of patients with nAMD.
“[This] regulatory designation offers benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new therapies to patients more quickly,” the company said.
Additional information on Opthea’s technology and the Phase 3 pivotal clinical trials can be found at www.opthea.com and at ClinicalTrials.gov (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636).
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