The dry eye treatment market is rapidly growing, yet new drug development remains a formidable challenge. The diverse causes of the condition make it difficult to demonstrate efficacy in clinical trials, leading global pharmaceutical companies to face setbacks. Nevertheless, the strong demand for effective treatments has prompted domestic companies to accelerate their drug development efforts.
According to market research firm Fortune Business Insights, the global dry eye treatment market is projected to grow from $8.55 billion this year to $15.09 billion by 2034.
In South Korea, the dry eye market was valued at approximately 480 billion won in 2024, according to Ubiest. The steady increase in patients, driven by the rise in digital device usage and the chronic nature of the condition requiring long-term management, has contributed to a stable market.
However, despite the market potential, new drug development is considered a significant challenge. Jeong Yoon-taek, head of the Pharmaceutical Industry Strategy Research Institute, cited the clinical characteristics of dry eye as a key reason for the difficulties in developing new treatments. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), require both objective measures, like tear production and corneal damage improvement, and subjective symptoms reported by patients, making the process of proving efficacy particularly complex.
AbbVie’s Restasis, a leading product in the dry eye market, is effective only for patients with inflammatory dry eye and typically takes about six months to show results. Artificial tears remain a symptomatic treatment, leaving a significant unmet medical need for a fundamental cure.
In this market context, domestic pharmaceutical companies are continuing their new drug development efforts. Huons has completed the first patient registration for the Phase 2 clinical trial of its dry eye drug candidate, HUC1-394. This peptide-based eye drop, introduced from Novacell Technology, aims to complete the trial with the last patient visit targeted for the second half of next year, followed by the release of the clinical study report. If efficacy and safety are confirmed, the company will prepare for Phase 3 trials.
While existing treatments focus on suppressing inflammation, HUC1-394 aims to promote the recovery of damaged tissue. The company expects it to fundamentally improve dry eye symptoms by healing the damaged ocular surface. This aligns with its goal of evolving from a generic manufacturer to a leading global ophthalmic company.
Hanol BioPharma is currently conducting Phase 3 trials for its dry eye drug, HL036 (active ingredient: Tanfanercept). The company has confirmed statistically significant improvement in one of the Phase 2 trial endpoints, the Schirmer test, and has set this as the primary endpoint for the ongoing Phase 3 trial. The Schirmer test is a standard measure for objectively assessing tear production and is utilized in both approved dry eye treatments and many new drugs under development.
Due to the high development difficulty, some companies are revising their strategies. Yuyu Pharmaceutical is considering changing the indication for its drug YP-P10 after it failed to demonstrate improvement in eye discomfort in Phase 2 trials. HLB Therapeutics is shifting its focus from developing RGN-259 for dry eye to treating neurotrophic keratitis (NK).
Jeong Yoon-taek noted, “Recently, various approaches, including forming an artificial lipid layer on the tear film to prevent moisture evaporation and nerve stimulation, are being explored. Efforts to overcome development challenges through drug repurposing and combination therapies are also ongoing.”
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.