The first patient in the Phase 3 clinical trial of a Melbourne-based drug company’s novel therapy for neovascular age-related macular degeneration (nAMD) has been treated in the US.
ASX-listed biopharmaceutical company Opthea announced on 15 March that the patient, enrolled at Cumberland Valley Retina Consultants, in Maryland, had received its first-in-class VEGF-C/D ‘trap’ inhibitor called OPT-302.
The patient is part of two concurrent global, multi-centre, randomised, double-masked, sham-controlled Phase 3 trials Opthea is conducting.
Known as Shore (an acronym for study of OPT-302 in combination with ranibizumab) and Coast (combination OPT-302 with aflibercept study), both trials will each enrol about 990 treatment-naïve patients.
The studies will assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab (Lucentis) or 2.0 mg aflibercept (Eylea), compared to ranibizumab or aflibercept monotherapy, respectively.
Opthea CEO Dr Megan Baldwin said the company wants to enrol more patients in the Phase 3 trials as soon as possible.
“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,” she said.
“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.”
According to the company, the primary endpoint of the Shore and Coast studies 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.
Each patient will also continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period.
Opthea will also evaluate a number of secondary endpoints, including other key measures of visual function, as well as anatomical changes in the wet AMD lesions assessed by OCT and fluorescein angiography imaging.
In addition, the company said, extended durability of the OPT-302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT-302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor.
Opthea anticipates reporting top-line data in 2023.