Opthea (ASX:OPT) has announced positive data from the Phase 1b dose escalation study of OPT-302 for patients with diabetic macular edema (DME).
The study evaluated three escalating dose levels of OPT-302 (0.3, 1.0 or 2.0 mg), a novel VEGF-C/D ‘Trap’ therapy, in combination with Bayer's EYLEA (aflibercept) administered once every four weeks for a total of three intravitreal injections in nine patients with persistent central-involved DME despite sub-optimal responses to standard of care anti-VEGF-A therapy.
Eyes with persistent DME sub-responsive to multiple prior anti-VEGF-A injections demonstrated visual and anatomic improvement at 12 weeks following conversion to OPT302 combination treatment, said the company.
“Alternative approaches such as combination therapies are needed for treating patients with DME who have persistent macula swelling and vision loss despite treatment with standard of care,” said DR David Boyer, clinical professor of ophthalmology at USC/Keck School of Medicine and principal investigator on the trial.
“I am highly encouraged by the evidence of efficacy and continued favourable safety profile for OPT-302 combination therapy which has potential to benefit the many diabetic patients who have limited responses to anti-VEGF-A treatment”.
Patients enrolled in the study had a history of diabetes with a mean duration of 14.1 years and persistent DME despite receiving a mean of 6.3 prior anti-VEGF-A injections.
"The mean change at week 12 from baseline in best corrected VA (BCVA) across all OPT-302 combination therapy dose groups was a gain of +7.7 letters (baseline of 65 letters) with a corresponding mean reduction in central subfield thickness (CST) of -71 µM (baseline of 434 µm)," said the company.
Dr Megan Baldwin, CEO and managing director of Opthea, said, “We are very encouraged by the results of this Phase 1b dose escalation study in patients with persistent DME. Together with previously reported results from our Phase 1/2a trial in wet AMD patients, we have now demonstrated a well-tolerated safety profile of OPT-302 in combination with aflibercept and ranibizumab (Lucentis) and promising signs of clinical activity in both wet AMD and DME patients.
"Our data suggests that VEGF-C/D blockade may provide additional clinical benefit over standard of care anti-VEGF-A therapy. To that end, we look forward to reporting outcomes from our two international, multicentre Phase 2 trials that are currently ongoing and actively recruiting patients with newly diagnosed wet AMD and persistent DME despite prior anti-VEGF-A therapy.”