Opthea Limited announced that it has now completed enrollment in both the COAST and ShORe trials constituting its pivotal Phase 3 clinical program. Opthea's Phase 3 clinical program consists of two multicenter, double-masked, randomized, sham-controlled trials COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab), which enrolled 1,984 treatment-naive wet AMD patients in total (998 patients in COAST; 986 patients in ShORe), making it one of the largest Phase 3 programs in wet AMD. The Company is currently conducting two concurrent pivotal Phase 3 multicenter, double-masking, randomized, sham-controlled clinical trials, COAST (Combination OPT -302 with Aflibercept Study), designed to assess the safety and superior efficacy of sozinibercept combination therapy versus standard-of-care anti-VEGF-A for the treatment of wet AMD. Opthea's Phase 3clinical trial program is designed to support a broad label and, if successful, sozinibercept has the potential to be approved for use in combination with any anti-VEGF-A For the treatment of all wet AMD patients. Sozinibercept has received Fast Track Designation from the U.S. FDA for the treatment of wet AMD; The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment
advice be sought prior to such investments.