[Edaily Reporter SONG YOUNG-DOO ] Olix Pharmaceuticals, Inc.(226950) Development of “OLX10212,” a candidate drug for age-related macular degeneration, has hit a snag in its Phase 2a clinical trial in New Zealand. This follows a determination by the local ethics committee that the clinical trial application did not meet national ethical standards and relevant regulations. The company plans to review the issues raised and pursue a re-evaluation and resubmission.

Olix Pharmaceuticals, Inc. announced on the 12th that it had been notified by the Northern B Health and Disability Ethics Committee (HDEC) in New Zealand that its application for approval of the Phase 2a trial protocol for OLX10212 had been rejected.

This clinical trial is designed to evaluate the efficacy and safety of OLX10212 in patients with age-related macular degeneration (AMD) accompanied by geographic atrophy (GA) in both eyes. The drug is administered via intravitreal injection, and the trial is designed as a multicenter, randomized, sham-controlled study.

According to the disclosure, the ethics committee rejected the application after determining that it did not meet New Zealand’s ethical standards and relevant regulations. However, specific details regarding which requirements were not met were not disclosed.

The reason for rejection stated in this announcement is failure to meet ethical and regulatory requirements for the clinical trial application. No specific findings regarding the drug’s efficacy or safety were presented in the announcement.

Olix Pharmaceuticals, Inc. stated, “We are carefully reviewing the issues raised by the Ethics Committee and preparing for a re-review and resubmission,” adding, “We plan to proceed with the relevant procedures promptly.”