Opthea finalizes study designs for the phase III ShORe and COAST pivotal clinical trials of OPT 302 in wet age-related macular degeneration.

Opthea Limited announces that it has finalized the protocol study designs and key start-up activities in readiness for the initiation of the Phase III ShORe and COAST pivotal clinical trials of OPT 302 in wet age-related macular degeneration (AMD). Finalization of the Phase III trial protocols follows productive consultations with the FDA, EMA and world-renowned Key Opinion Leaders (KOLs) in wet AMD. The trial protocols have also been submitted to relevant regulatory agencies, institutional review boards and human research ethics committees. Two global experts in the treatment of retinal diseases, Prof Timothy Jackson and Dr Charles Wykoff, will be the Chief investigators for the ShORe (Study of OPT-302 in combination with Ranibizumab) and COAST (Combination OPT-302 with Aflibercept Study) trials, respectively. Professor Jackson, PhD, FRCOphth, is a consultant ophthalmic surgeon at King's College, London, and was also the Chief Investigator on the Opthea Phase IIb wet AMD clinical trial. Dr Wykoff, MD PhD, is the Director of Research, Retina Consultants of Texas and Deputy Chair for Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, Houston Texas. Another eminent retina specialist, Dr Jason Slakter, founder and Director of the Digital Angiography Reading Center (DARC) in New York, and Clinical Professor of Ophthalmology at NYU School of Medicine, will also provide expertise as a leading authority on ocular imaging for the Phase III clinical program. The global, multi-centre, double-masked, sham-controlled, pivotal Phase III clinical trials will each enrol ~990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT 302 in combination with 0.5 mg ranibizumab (Lucentis ) (ShORe trial) or 2.0 mg aflibercept (Eylea) (COAST trial), compared to ranibizumab or aflibercept monotherapy, respectively. In addition, extended durability of the OPT 302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT 302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor. If effective in these Phase III studies, OPT 302 could be adopted for administration with either Eylea or Lucentis which had combined sales for retinal diseases of $11.9 billion in 2019. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT 302 combination therapy compared to anti-VEGF-A monotherapy. Each patient will continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period. Opthea remains on track to initiate the trials in the first quarter of calendar year (CY) 2021 and to report top-line data in the second half CY 2023. If the results at the completion of the primary efficacy phase at week 52 of the Phase III clinical trials are favourable, the Company intends to submit Biologics License and Marketing Authorisation Applications with the FDA and EMA respectively for marketing approval for OPT-302 for the treatment of wet AMD in the United States, European Union and other global territories.