Melbourne biopharmaceutical company Opthea has completed the patient recruitment phase for the latest trial of its novel therapy for diabetic macular edema (DME).
The ASX-listed firm is conducting a Phase 2a trial which will evaluate the safety and efficacy of OPT-302 when administered in combination with aflibercept (Eylea) in DME patients.
It comes after the company demonstrated the benefits of its therapy for neovascular age-related macular degeneration (AMD) patients last August. In that trial, patients treated with OPT-302, in conjunction with ranibizumab (Lucentis), had superior visual acuity compared with those who received Lucentis alone.
According to Opthea, it is the only company targeting VEGF C/D in this way. It believes OPT-302 has significant commercial potential for diseases in which limited standard-of-care treatments, with anti-VEGF-A monotherapy, have produced suboptimal outcomes for many patients.
“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,” Dr Megan Baldwin, CEO of Opthea, 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.”
She added: “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 trial will be a randomized, dose expansion study designed to enrol at least 108 patients with persistent centre-involved DME, despite regular administration of prior anti-VEGF-A monotherapy.
Participants will be allocated in a 2:1 ratio and receive a combination of aflibercept (2 mg) and OPT-302 (2 mg), or aflibercept monotherapy. Treatments will be administered by intravitreal injection once every four weeks, with a 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 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.