Eye disease specialist Opthea Limited (ASX:OPT) has reached a critical milestone in proving OPT-302 combination therapy in a larger patient population for the treatment of diabetic macular edema (DME), a major world-wide health issue.
The company’s CEO, Dr Megan Baldwin, reported Opthea has now successfully completed patient recruitment for its Phase 2a trial evaluation of the safety and efficacy of OPT-302 administered in combination with aflibercept (Eylea) for treatment of 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 Dr Baldwin said.
“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.”
Dr Baldwin said the ongoing Phase 2a DME study is further evaluating OPT-302 combination therapy in a larger patient population to confirm these observations.
“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 aflibercept (2 mg) + OPT- 302 (2 mg) or aflibercept monotherapy,” Dr Baldwin said.
“Treatments are administered by intravitreal (ocular) injection once every 4 weeks (total of 3 doses). The primary efficacy analysis endpoint is the clinical response rate, defined as the proportion of patients receiving combination OPT-302 and aflibercept 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.
Current standard-of-care treatment with anti-VEGF- A monotherapy has shown suboptimal outcomes in many patients who continue to have persistent fluid and/or impaired vision, which represents a large unmet medical need. OPT-302 blocks VEGF-C and VEGF-D, two factors involved in vessel growth and leakage in the eye, and when used in combination with a VEGF-A inhibitor, has the potential to improve clinical outcomes in DME patients.
“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,” Dr Baldwin said.