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Opthea meets US and European regulators over Phase 3 trial

A Melbourne-based drug company is one step closer to starting Phase 3 clinical trials and pre-commercial development of its novel treatment for neovascular age-related macular degeneration (nAMD).

ASX-listed biopharmaceutical company Opthea announced on 21 August that it has successfully completed meetings with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to obtain guidance on the Phase 3 clinical development plans of OPT-302 as a treatment for nAMD.

Dr Megan Baldwin, Opthea CEO.

In a statement following the successful meetings, the company said it is on-track to initiate Phase 3 trials in early 2021.

According to Opthea, the FDA and EMA have agreed on key aspects of the proposed Phase 3 clinical trial designs, including the conduct of two concurrent, global, multicentre, randomised, sham-controlled studies evaluating OPT-302 in combination with ranibizumab (Lucentis) or aflibercept (Eylea).

The company is expecting to enroll at least 900 patients worldwide in each trial.

“If successful, the investigation of OPT-302 in combination with two approved standard-of-care VEGF-A inhibitors could enable OPT-302 to be administered with either Eylea or Lucentis which had combined sales for retinal diseases of US$11.9 billion (AU$16.6b) in 2019,” the company stated.

Each trial will compare the clinical efficacy of OPT-302 administered in combination with a VEGF-A inhibitor on an every four-week and every eight-week dosing regimen in order to understand the durability of OPT-302 treatment effect with less frequent dosing.

“The primary endpoint is mean change in visual acuity from baseline to week 52 for OPT-302 and anti-VEGF-A combination therapy compared to anti-VEGF-A monotherapy,” Opthea stated.

The company is intending to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA respectively, following completion of the primary efficacy phase of the trials.

Each patient will continue to be treated for a further year to evaluate safety and tolerability over a two-year period, according to Opthea.

Opthea CEO Dr Megan Baldwin said they received valuable guidance from the FDA and EMA.

“[Which] provides clear direction as we advance our Phase 3 registration program towards bringing OPT-302 to market,” Baldwin said.

“We remain focused on further demonstrating, in our Phase 3 program, the potential of OPT-302 combination therapy as a novel and transformative treatment for wet AMD patients suffering vision loss.”

She continued: “The analysis approach for our Phase 3 clinical trials allows the initial analysis of outcomes to be evaluated in the patient group which, based on data from our Phase 2b trial, would be expected to have the best response to OPT-302 combination therapy.

“We believe this approach achieves the highest probability of success for our Phase 3 program and commercialisation strategy.”

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