Company explained, “Some of the clinical trial submission data needs to be supplemented.”
Australia's Phase 2a application for approval in September... Promote follow-up procedures according to the original plan
The New Zealand phase 2a clinical trial application for Olix (226950)’s macular degeneration treatment program ‘OLX301A (substance name OLX10212)’ was rejected by the local ethics committee. The company explained that this was an issue that required supplementation of some of the submitted data, and announced that it would pursue follow-up procedures such as resubmission after supplementation.
Olix announced on the 12th that the New Zealand Northern B Health and Disability Ethics Committee (HDEC) had rejected the clinical trial application. The committee determined that the application did not meet local ethical standards and relevant laws.
In a separate notice, the company explained that this approval was based on the local review agency's opinion that some of the submitted data related to clinical trials needed to be supplemented. We plan to carefully review related matters, make necessary supplements, and quickly proceed with follow-up procedures such as resubmission. The announcement said that it was preparing for reconsideration and resubmission.
Previously, Olix announced through a correction announcement on the 30th of last month that it had applied for approval of the phase 2a clinical trial plan for OLX10212 from the New Zealand Medicines and Medical Device Safety Authority (Medsafe). The organization that made this rejection decision is the Northern B Ethics Committee.
Along with the supplementary procedures for New Zealand applications, clinical trials in Australia will also be promoted. Olix completed the application for approval of the Australian phase 2a clinical trial plan last September and explained that it would proceed with follow-up procedures according to the original development plan.
This clinical trial is a test to evaluate the effectiveness and safety of OLX10212 in patients with age-related macular degeneration (AMD) with geographic atrophy (GA) in both eyes. At various clinical institutions, patients are randomly assigned to a drug administration group and a sham treatment control group, and the test group is designed to inject the drug into the vitreous cavity of the eye.
