Australian clinical-stage biopharmaceutical company Opthea (ASX:OPT) says it has completed patient recruitment into the phase 2a trial evaluating the safety and efficacy of its OPT-302 administered in combination with Bayer's EYLEA (aflibercept) for treatment of diabetic macular edema (DME).
“We are delighted to have completed patient enrolment into the Phase 2a DME study which marks another significant milestone in a second disease indication for the company,” said CEO Dr Megan Baldwin.
“We are excited about the potential for OPT-302 in DME given the positive outcomes of our Phase 2b wet AMD study, as well as our earlier positive Phase 1b clinical results which showed dose escalation of OPT-302 combination therapy was well tolerated with improved visual and anatomic outcomes in patients with treatment resistant and persistent DME.
"The ongoing Phase 2a DME study is further evaluating OPT-302 combination therapy in a larger patient population to confirm these observations and we look forward to reporting topline data in the second quarter of 2020.”
The company said the Phase 2a trial is a randomised, dose-expansion study, designed to enrol at least 108 evaluable patients diagnosed with persistent centre-involved DME despite regular administration of prior anti VEGF-A monotherapy.
Participants were allocated in a 2:1 ratio to either EYLEA (2 mg) plus OPT-302 (2 mg) or EYLEA monotherapy.
Treatments are administered by intravitreal (ocular) injection once every four weeks (total of three doses).
The primary efficacy analysis endpoint is the clinical response rate, defined as the proportion of patients receiving combination OPT-302 and EYLEA achieving a ≥5 letter gain in visual acuity at week 12 compared to baseline. Secondary efficacy measures include mean visual acuity, macular thickness, improvement in diabetic retinopathy severity score and durability of response.
DME is a complication of diabetes that is estimated to affect over two million people globally and is the leading cause of vision loss amongst the working-age population. Fluid from blood vessel leakage in the eye accumulates in the macula, or central portion of the retina, and the resultant swelling leads to blurred vision and blindness.
“With the recruitment target now met for the Phase 2a DME study, Opthea’s management team is now fully focused on corporate activities to progress OPT-302 into Phase 3 studies for wet AMD and preparing to report topline data from the Phase 2a DME trial in the second quarter of calendar year 2020 following the completion of patient dosing, study visits, data collection and statistical analyses,” added Dr Baldwin.