HLB Therapeutics Submits Additional Pre-Discussion Request to FDA for Dry Eye Disease

Treatment for Dry Eye Syndrome 'RGN-259'
SPA Application Submitted... Clinical Trial Targeted for Q2 Next Year

[Asia Economy Reporter Chunhee Lee] HLB Therapeutics announced on the 24th that it has submitted a Special Protocol Assessment (SPA) application to the U.S. Food and Drug Administration (FDA) for preliminary discussions on the additional Phase 3 clinical trial design (protocol) of the dry eye treatment ‘RGN-259,’ which is being developed through its U.S. subsidiary ReGenTree.

SPA is a system in which the FDA reviews and agrees whether the clinical trial design and statistical analysis plan submitted by the developer meet the requirements necessary for new drug development and approval. The developer then conducts the clinical trial according to the protocol decided through this process.

The company explained that by using the SPA program, the possibility of incorrect clinical trial design arising during the FDA’s review of approval documents after the clinical trial can be minimized. According to FDA guidance, the official review period for protocol evaluation is 45 days.

HLB Therapeutics plans to use this to discuss the 4th clinical trial (ARISE-4) of RGN-259. A company official said, "We submitted briefing documents summarizing the clinical data from the previously conducted 'ARISE-1·2·3' trials, along with the ARISE-4 protocol and statistical analysis plan to the FDA. We will finalize the clinical direction of ARISE-4 through consultation with the FDA and do our best to start the clinical trial promptly."

HLB Therapeutics expects that once the SPA procedure is completed, the ARISE-4 clinical trial could begin around the second quarter of next year.