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Opthea hits recruitment target for diabetic study

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.

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