Huons receives MFDS IND clearance for phase 2 study of HUC1-394 in dry eye disease

Huons Co., Ltd. has received investigational new drug (IND) approval from South Korea’s Ministry of Food and Drug Safety (MFDS) to initiate a phase 2 clinical trial evaluating HUC1-394, a peptide-based ophthalmic solution targeting inflammatory pathways in dry eye disease (DED). The planned study will assess the safety, efficacy, and optimal dosing of the investigational therapy in approximately 150 patients with DED.¹

The decision allows investigators to proceed with a multicenter, randomized, double-blind, placebo-controlled study in South Korea. The trial represents the next stage of clinical development following phase 1 testing in healthy volunteers, which reported favorable tolerability and no serious adverse events (SAEs).¹,² If successful, the program could add a novel anti-inflammatory mechanism to a therapeutic landscape currently dominated by topical immunomodulators and anti-inflammatory agents.

Trial Overview

According to company disclosures, the phase 2 trial will enroll roughly 150 patients diagnosed with dry eye disease across multiple centers, including Severance Hospital at Yonsei University College of Medicine. Participants will be randomized in a 1:1:1 ratio to two active-treatment arms or a vehicle control arm. The study will evaluate different dosing regimens over a 12-week treatment period.³

The trial’s primary objectives include evaluating safety and determining the optimal dosing regimen while assessing clinical efficacy signals in patients with DED. Endpoints have not been publicly detailed in full, but typical phase 2 ophthalmic trials for dry eye often assess signs and symptoms such as corneal staining scores, tear film break-up time, and patient-reported symptom measures.

The investigational therapy previously underwent a phase 1 study involving 60 healthy adults. That study evaluated single-ascending-dose and multiple-ascending-dose administration of the topical therapy. No serious adverse events were reported, and most treatment-emergent adverse events were mild and resolved during the observation period.²

Mechanism of Action

HUC1-394 is a peptide-based ophthalmic solution licensed from NOVACELL Technology Inc. The compound acts as a selective agonist of formyl peptide receptor 2 (FPR2), a G-protein–coupled receptor involved in regulating inflammatory responses.¹,²

Activation of FPR2 is thought to promote the resolution phase of inflammation rather than broadly suppressing inflammatory signaling. In theory, this approach could reduce ocular surface inflammation while supporting tissue repair processes associated with keratoconjunctivitis seen in DED.¹

Although the concept of targeting pro-resolution pathways has been explored in inflammatory diseases, FPR2 agonists remain largely investigational in ophthalmology. As such, the clinical relevance of this pathway in dry eye disease remains to be validated in later-stage trials.

Clinical Context

Dry eye disease is a multifactorial disorder of the ocular surface characterized by tear film instability, inflammation, and neurosensory abnormalities. Prevalence estimates vary widely depending on diagnostic criteria and population studied but have been reported to range from approximately 5% to 50% globally.⁴

Current prescription therapies for DED primarily target inflammatory pathways or tear production. These include topical cyclosporine formulations and lifitegrast, a lymphocyte function–associated antigen-1 (LFA-1) antagonist approved in the United States in 2016.⁵ These treatments can improve symptoms and signs of DED but are associated with limitations, including delayed onset of action, local irritation, and discontinuation due to tolerability issues.⁶

Real-world studies suggest that many patients remain symptomatic despite treatment or discontinue therapy due to adverse effects such as burning sensations, blurred vision, or dysgeusia.⁶ As a result, ophthalmology researchers continue to explore new mechanisms of action that may address ocular surface inflammation more effectively or with improved tolerability.

Drug Development Background

HUC1-394 is being developed as a new chemical entity within Huons’ ophthalmology pipeline and is categorized as an FPR2-selective peptide ligand. Company pipeline materials indicate that the therapy is designed to modulate immune signaling through innate inflammatory pathways and potentially restore ocular surface homeostasis.⁷

The candidate has been licensed from NOVACELL Technology Inc., reflecting a broader trend in ophthalmic drug development toward peptide-based therapeutics. Peptide drugs can offer high receptor specificity but may face challenges related to stability, ocular penetration, and manufacturing scalability.

To date, no peer-reviewed clinical trial results for HUC1-394 have been published in the scientific literature. Available data come primarily from company reports and press materials.

Interpretation and Next Steps

While the initiation of a phase 2 study represents an important milestone, the clinical impact of HUC1-394 remains uncertain. Early-phase trials are primarily designed to evaluate safety and explore dosing rather than demonstrate definitive efficacy.

Key questions for clinicians include whether FPR2 activation can meaningfully improve both the signs and symptoms of DED and how the therapy’s safety and tolerability compare with existing anti-inflammatory treatments. The upcoming trial will also help determine whether targeting inflammation-resolution pathways translates into measurable clinical benefit.

If positive, the phase 2 study could support larger confirmatory trials and potentially introduce a new therapeutic class for DED. However, additional evidence—including peer-reviewed clinical data and long-term safety evaluation—will be required before the drug’s clinical role can be defined.

References

1. Huons Co., Ltd. Huons advances clinical development of HUC1-394 for dry eye disease. Accessed March 12, 2026.
   https://huons.com/en/product/news_view/5705

2. Harp MD. Phase 1 trial findings confirm safety and tolerability of Huons’ dry eye therapy. Ophthalmology Times. Accessed March 12, 2026.
   https://www.ophthalmologytimes.com/view/phase-1-trial-confirms-safety-and-tolerability-of-huons-dry-eye-therapy

3. Huons regulatory disclosure: Phase 2 clinical trial plan approval for HUC1-394. Accessed March 12, 2026.
   https://www.awakeplus.co.kr/data/view/20260311902478

4. Storås AM, et al. Artificial intelligence in dry eye disease. arXiv. 2021. Accessed March 12, 2026.
   https://arxiv.org/abs/2109.01658

5. Sheppard JD, et al. Lifitegrast ophthalmic solution for treatment of dry eye disease: systematic review and meta-analysis. J Clin Med. 2022.
   https://pubmed.ncbi.nlm.nih.gov/36078948/

6. Farhangi M, et al. Treatment satisfaction among patients using anti-inflammatory topical medications for dry eye disease. Clin Ophthalmol. 2020.
   https://www.tandfonline.com/doi/full/10.2147/OPTH.S233194

7. Huons R&D pipeline overview. Accessed March 12, 2026.
   https://www.huons.com/en/rnd/research