HLB Therapeutics Progressing Smoothly with Pre-BLA Preparation... "Former American Ophthalmological Society President's Positive Opinion"

[Asia Economy Reporter Hyunseok Yoo] ReGenTree, a subsidiary of HLB Therapeutics, is making smooth progress in preparing for the Pre-BLA (pre-Biologics License Application) meeting with the U.S. FDA regarding its dry eye disease treatment candidate (RGN-259).

According to industry sources on the 12th, HLB Therapeutics, which completed its third Phase 3 clinical trial (ARISE-3) last year, plans to hold a meeting with the U.S. Food and Drug Administration (FDA) on February 28 to discuss the format and content of the marketing authorization application. To this end, the company intends to submit clinical data as well as non-clinical, manufacturing, and quality-related documents at least 30 days prior to the meeting.

Dr. Stephen C. Pflugfelder, a leading KOL (Key Opinion Leader) in ophthalmology, especially in ocular surface diseases in the U.S., who reviewed the clinical results included in the prepared meeting materials, stated, "The design and results of the three Phase 3 clinical trials have been very clearly organized. The post-hoc analysis and pooled data from approximately 1,000 subjects across all clinical trials demonstrated improvements in both symptoms and signs, and I believe safety and tolerability have also been proven."

He added, "The FDA is well aware that it is very difficult to demonstrate efficacy on both symptoms and signs simultaneously in a single clinical trial for new dry eye disease drugs, so I expect they will be willing to review the clinical data of RGN-259 from the perspective of data totality," conveying a positive opinion to HLB Therapeutics.

Dr. Pflugfelder is a distinguished figure with extensive clinical experience and over 300 published papers in ophthalmology. He currently serves as a professor at Baylor College of Medicine in the U.S. He also served as president of ARVO, the world’s largest ophthalmology academic society with over 10,000 ophthalmologists and vision science researchers from 75 countries, until 2021.

An official from HLB Therapeutics said, "Although the company remains cautious, receiving positive feedback from the world-renowned Dr. Pflugfelder regarding the clinical results and Pre-BLA preparation is very encouraging. We will prepare materials on non-clinical studies and quality, and clearly organize the strengths of our product to ensure a productive meeting with the FDA during the remaining period."