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Colin Hay

Melbourne-headquartered clinical- stage biopharmaceutical company Opthea Limited (ASX:OPT) completed enrolment of all patients in the COAST Phase 3 pivotal clinical trial.

The trial is investigating sozinibercept (OPT-302, a vascular endothelial growth factor (VEGF)-C/D inhibitor) in combination with aflibercept, an anti-VEGF-A therapy, for the treatment of wet Age-related Macular Degeneration (wet AMD).

The sozinibercept clinical programme includes two Phase 3 pivotal trials, COAST and ShORe. Enrollment in ShORe is expected to be completed in calendar Q2 2024. Opthea intends to report topline results from these two trials by mid-2025.

“Completion of patient enrollment in our first pivotal trial marks an important milestone in the development of sozinibercept for the treatment of wet AMD,” said Frederic Guerard, CEO of Opthea.

“We believe sozinibercept has the potential to provide superior clinical results, based on the strength of our Phase 2b trial, which demonstrated a statistically significant improvement in visual acuity for patients treated with sozinibercept combined with LUCENTIS (ranibizumab) compared to ranibizumab alone,” Mr Guerard said.

“We look forward to maintaining this positive momentum and completing enrollment in the ShORe pivotal trial in calendar Q2 2024, with a goal of communicating topline results for both trials by mid-2025.”

About Sozinibercept

Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralises the activity of VEGF-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Research indicates that targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage which contribute to the pathophysiology of retinal diseases including wet AMD.

Sozinibercept has received Fast Track Designation from the US FDA for the treatment of wet AMD.

Positive results from the Phase 2b study of sozinibercept, administered in combination with LUCENTIS (ranibizumab) for the treatment of wet AMD, published in Ophthalmology, met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone.

In addition, secondary outcomes were positive for the combination therapy with sozinibercept, including more participants with gains in vision of 10 or more letters, improved anatomy with reduction in swelling and vascular leakage, with a favorable safety profile.

Clinical Trials

Opthea is conducting two concurrent global pivotal Phase 3 clinical trials for the treatment of wet AMD aiming at demonstrating superiority of its combination therapy versus standard of care: COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab).

If successful, the investigation of sozinibercept in combination with each of these two approved standard of care VEGF-A inhibitors could enable sozinibercept to be administered with either agent, EYLEA (aflibercept) or LUCENTIS (ranibizumab).

The two pivotal Phase 3 multi-centre, double-masked, sham-controlled trials are designed to assess the efficacy and safety of intravitreal 2.0 mg sozinibercept in combination with anti-VEGF- A treatments.

In the COAST trial, sozinibercept is being evaluated in combination with 2.0 mg of EYLEA (aflibercept). In the ShORe trial, sozinibercept is being evaluating in combination with 0.5 mg of LUCENTIS (ranibizumab). The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy.

In addition, each trial will evaluate the use of sozinibercept treatment dosed every four weeks and every eight weeks after the first three loading doses.

Beyond week 52, patients will continue to be treated for an additional year to evaluate extended safety and tolerability up to a two-year period.

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