GTreeBNT Announces Additional Analysis Results of Phase 3 Clinical Trial for Dry Eye Treatment ‘RGN-259’

According to US FDA Dry Eye Treatment Guidelines
Confirmed Efficacy and Safety Based on Pre-Set Evaluation Criteria
Plan to Hold Pre-BLA Meeting Based on ARISE-1,2,3 Full Data

[Asia Economy Reporter Jang Hyowon] GTreeBNT announced that it will explain the final analysis results of the Phase 3 clinical trial (ARISE-3) in the United States for the dry eye disease treatment ‘RGN-259,’ developed through its U.S. subsidiary ReGenTree, at a corporate briefing for all investors on the afternoon of the 14th.

RGN-259, a dry eye disease treatment developed by GTreeBNT, uses ‘Thymosin beta 4’ as the active ingredient, which has various therapeutic mechanisms including anti-inflammation, wound healing, cell protection, promotion of cell migration, and inhibition of apoptosis, all of which help with the characteristics of multifactorial diseases. This Phase 3 clinical trial by GTreeBNT tested efficacy and safety on a total of 700 subjects and was conducted at ophthalmology hospitals across the United States.

Regarding the development of dry eye disease treatments, the U.S. FDA established new guidelines last year and recommended various evaluation parameters as criteria for confirming new drug efficacy. The FDA advises confirming statistically significant differences in prespecified parameters for both objective signs and subjective symptoms, indicating a progressive change in the standards for new dry eye drug development in the U.S.

The company stated that in the results of this clinical trial, statistically significant differences were confirmed in several prespecified evaluation items, including grittiness after 1 and 2 weeks of administration and after exposure to harsh conditions, ocular discomfort during the first week of administration according to subject diaries, and symptoms measured by the Ocular Surface Disease Index (OSDI) after 2 weeks of administration.

Regarding signs, additional analyses using patient groups classified by baseline corneal fluorescein staining scores across the entire corneal area showed statistically significant differences in central corneal fluorescein staining scores 2 weeks after administration in the analyses of ARISE-3 and combined ARISE-1, 2, and 3 trials.

Furthermore, among patient groups classified by baseline inferior corneal fluorescein staining scores and tear volume, statistically significant differences were confirmed in central corneal fluorescein staining scores 2 weeks after administration in ARISE-2 and combined ARISE-1, 2, and 3 patient groups.

A company representative said, “We have once again confirmed the safety and efficacy of RGN-259 through the entire Phase 3 clinical data from ARISE-1, 2, and 3 and the current Phase 3 trial (ARISE-3).”

He added, “Based on this clinical data and the overall data, we reaffirmed the efficacy of RGN-259, which has been steadily developed for drug approval, and we could once again anticipate its potential as a next-generation dry eye disease treatment. Since the U.S. FDA classifies the product approval process for RGN-259 as a BLA (Biologics License Application), we have started close consultations with expert groups in the U.S. to explore the possibility of applying for a Pre-BLA meeting, and we plan to begin the Pre-BLA meeting application in the third quarter of this year.”

Meanwhile, GTreeBNT plans to focus on deriving the most strategic conclusions among the various efficacy results of signs and symptoms secured through the interpretation of the FDA’s newly established dry eye disease guidelines from last December and the current clinical results. If RGN-259 is approved via BLA, it will be granted 12 years of market exclusivity as a new drug. The company is also known to plan to announce the overall details of this clinical result at today’s corporate briefing.