Emerging Australian biotechnology company Opthea (ASX:OPT) has announced that the first patient has been treated in the phase three pivotal clinical program of its first-in-class VEGF-C/D ‘trap’ inhibitor.
The therapy, OPT-302, is being studied in patients with treatment-naïve wet (neovascular) age-related macular degeneration (AMD). The first patient was enrolled by Dr Allen Hu in the US.
“Dosing the first patient in our OPT-302 Phase 3 pivotal clinical program in wet AMD marks a very important achievement for Opthea in accelerating the development of this novel VEGF-C/D inhibitor therapy towards market registration,” said CEO Dr Megan Baldwin.
“We are now looking forward to quickly ramping up enrolment to meet the interest from participating clinical sites and retinal specialists. OPT-302, which has shown promising efficacy and favourable safety profiles in trials to date, is an important new treatment option which may offer patients improved outcomes when administered in combination with VEGF-A inhibitors.”
Opthea is conducting two concurrent global, multi-centre, randomised, double-masked, sham-controlled phase three trials known as ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study).
Both clinical studies will enrol around 1,000 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with Novartis’ LUCENTIS (ranibizumab) or Bayer’s EYLEA (aflibercept).
The new trials follow the reporting of positive outcomes from the phase two study of OPT-302 in 366 patients with wet AMD. The results from that study demonstrated a statistically significant superior mean gain in visual acuity in patients treated with OPT302 combination therapy compared to EYLEA monotherapy at week 24.
Opthea said it anticipates reporting top-line data in 2023.