The Opthea Ltd (ASX: OPT) share price has been a positive performer on Tuesday morning.
At the time of writing the clinical stage biopharmaceutical company's shares are up almost 2% to $2.98.
Why is the Opthea share price pushing higher?
Investors have been buying Opthea's shares following an update on its phase 2a trial evaluating the safety and efficacy of OPT-302 in combination with aflibercept (Eylea) for the treatment of diabetic macular edema (DME).
According to the release, the novel biologic therapy developer has completed the patient recruitment for the phase 2a trial.
The company's CEO, Dr Megan Baldwin, was delighted with the patient enrolment and believes it "marks another significant milestone in a second disease indication" for Opthea.
Dr Baldwin appears very optimistic on OPT-302's potential in DME.
She 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."
"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," she added.
What now?
Opthea will now push on with its phase 2a trial. The trial sees participants administered by intravitreal (ocular) injection once every four weeks for a total of three doses.
The primary efficacy analysis endpoint is the clinical response rate. This is 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 the baseline.
Secondary efficacy measures include mean visual acuity, macular thickness, improvement in diabetic retinopathy severity score and durability of response.
Dr Baldwin concluded: "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."
