OliX announced that it has submitted a Phase 2a clinical trial plan to the Bellberry Human Research Ethics Committee (Bellberry HREC) in Australia to evaluate the efficacy and safety of OLX10212 in patients with age-related macular degeneration (AMD) accompanied by bilateral geographic atrophy (GA). The submission was made on the 16th.

[Multicenter, Randomized, Sham-Controlled Phase 2a Trial] The clinical trial will be conducted as a multicenter, randomized, sham-controlled study in patients with age-related macular degeneration accompanied by bilateral geographic atrophy, with OLX10212 administered via intravitreal injection. The purpose of the trial is to evaluate the efficacy of multiple intravitreal injections of OLX10212 over a 24-week treatment period on the progression of Total Attenuation of the Ellipsoid Zone.

Subjects will be assigned to either the treatment group or the sham-control group. The treatment group will receive OLX10212 via intravitreal injection once every two months, for a total of three doses, while the sham-control group will receive sham treatment on the same schedule. The total duration, including treatment and monitoring periods, is 48 weeks.

The target number of subjects is 64, and the clinical trial period is approximately 38 months from the date of approval. The overall trial period may vary depending on patient enrollment.

[Multinational Trial Across Four Countries: Australia, New Zealand, the United States, and South Korea] The clinical trial is planned to be conducted in a total of four countries: Australia, New Zealand, the United States, and South Korea. In Australia, the trial will initially be conducted at up to six sites, and the participating countries and institutions may be adjusted according to the development strategy. OliX plans to disclose related information through correction disclosures when submitting clinical trial plans in each country.

[Investment Caution: Statistical Probability of Final Approval Approximately 10%] OliX noted in its investment cautionary statement that the statistical probability of a clinical trial drug receiving final approval as a pharmaceutical product is known to be approximately 10%. It also stated that the clinical trial and product approval process may yield results that fall short of expectations, and that commercialization plans may accordingly be changed or abandoned.