GTreeBNT Announces Mid-Progress Stage of Pre-BLA Meeting for Dry Eye Disease Treatment

[Asia Economy Reporter Jang Hyowon] GTreeBNT announced the progress as of the 14th after presenting additional analysis results of the Phase 3 clinical trial of the dry eye treatment ‘RGN-259’ at the corporate briefing session last May.

GTreeBNT is developing the dry eye treatment ‘RGN-259’ through its U.S. subsidiary ReGenTree. After contracting with an FDA regulatory consulting firm, ReGenTree is smoothly conducting a gap analysis to review not only the clinical fields previously conducted for the development of RGN-259 as a dry eye treatment but also non-clinical trials, manufacturing and quality control (CMC) data, and discussions with the FDA during the development process, in order to explore the possibility of a Pre-BLA (Biologics License Application) meeting.

A GTreeBNT official stated, “Although the gap analysis is still ongoing with the consulting firm, we received an opinion that there is a possibility of a Pre-BLA meeting,” adding, “We are focusing on preparing for the Pre-BLA meeting while conducting an in-depth gap analysis through close discussions with expert groups, and we plan to proceed with the Pre-BLA meeting according to our targeted timeline. Whether the FDA accepts the Pre-BLA meeting will be officially confirmed by submitting a meeting request.”

The Pre-BLA meeting is held to discuss with the FDA’s licensing document review department whether the applicant’s BLA preparation plan and content related to the final approval stage, i.e., BLA submission, are appropriate. If the Pre-BLA meeting request is accepted, the applicant must submit detailed materials for the meeting questions to be discussed with the FDA at least one month before the meeting date.

According to FDA guidance, even if the applicant submits a meeting request for the purpose of a Pre-BLA meeting, the FDA may reject the Pre-BLA meeting or change it to another appropriate type of meeting corresponding to an earlier development stage, depending on the development status and contents described in the request.

In this regard, GTreeBNT is known to plan to submit the meeting request to the FDA within the third quarter along with the questions to be discussed at the Pre-BLA meeting upon completion of the gap analysis.

This content was produced with the assistance of AI translation services.