The Opthea Ltd (ASX: OPT) share price is surging higher today. This follows the release of an update on its meetings with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
At the time of writing the clinical-stage biopharmaceutical company's shares are up over 5% to $2.45.
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What happened at the Opthea-FDA meeting?
Opthea, which is developing a novel therapy to treat highly prevalent and progressive retinal diseases, has successfully completed its end-of-phase 2 meetings with the FDA and also a scientific advice meeting with the EMA.
These meetings have been undertaken to receive guidance on the phase 3 clinical development plans of OPT-302 as a treatment for neovascular (wet) age-related macular degeneration (AMD).
According to the release, the outcome of the meetings supports the progression of OPT-302 into Phase 3 and pre-commercial development, with the company aiming to initiate phase 3 trials in early 2021.
What now?
Management advised that the meeting covered key elements of the phase 3 clinical studies and associated manufacturing processes for OPT-302 that will support the submission of a Biologics License Application in the US and Marketing Authorisation Application in Europe for the targeted wet AMD indication.
Both the FDA and EMA agreed on key aspects of the proposed phase 3 clinical trial designs. This includes the conduct of two concurrent, global, multi-centre, randomised, sham-controlled studies evaluating OPT-302 in combination with ranibizumab (Lucentis).
If successful, the investigation of OPT-302 (in combination with two approved standard of care VEGF-A inhibitors) could enable it to be administered with either Eylea or Lucentis.
This could be very lucrative for Opthea given that these two products had combined sales for retinal diseases of US$11.9 billion in 2019.
Furthermore, each trial will compare the clinical efficacy of OPT-302 administered in combination with a VEGF-A inhibitor on an every 4-week and every 8-week dosing regimen in order to understand the durability of OPT-302 treatment effect with less frequent dosing.
Clear direction.
Opthea's Chief Executive Officer, Dr Megan Baldwin, commented: "We are very pleased with the valuable guidance received from the FDA and EMA which provides clear direction as we advance our Phase 3 registration program towards bringing OPT-302 to market."
"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 added.
