Korean pharmaceutical companies are striving to develop new drugs to treat dry eye syndrome in a 3 trillion won ($2.65 billion) global market, and 160 billion won domestic market.
Dry eye syndrome is a common eye condition in which the eye surface gets damaged due to insufficient tear production or excessive tear evaporation. The number of patients suffering from the disorder is on the rise because of the increase of computers, smart devices, air conditioners, and heaters.
According to data from the Health Insurance Review & Assessment Service, the number of Korean patients more than doubled in a decade to 2.14 million in 2014 from 970,000 in 2004. The total medical spending on dry eye treatments has climbed 8.6 percent annually during the cited period.
Treatments for dry eye vary, ranging from eye drops and anti-inflammatory therapy to the treatment of infected eyelid and surgery, depending on the severity of the condition. Among them, eye drops are most common.
To meet the growing needs of patients with dry eyes, Korean pharmaceutical companies are pushing to develop new treatments. New attempts include complementing the shortcomings of the existing drugs and changing their dosage forms.
Huons in 2015 launched Clacier Eye Drops using cyclosporine, the ingredient used most by dry eye patients. Improved from Allergan’s non-transparent solution Restasis, Clacier is transparent and does not require shaking.
Huons is developing a new treatment, called “HU024,” using recombinant protein. The company hopes that its new bio drug will replace Restasis, as HU024 will help goblet cells to proliferate and treat the abrasion, as well as work as an anti-inflammatory drug. Huons is preparing a phase-2 clinical trial on the new drug in the U.S.
Samjin Pharm is developing the industry’s first oral medication for dry eyes, called “SA001.” The new drug proved its efficacy in proliferating goblet cells that secrete mucins on the conjunctiva, in a study comparing the effectiveness of eye drops containing 0.1 percent hyaluronate (HA) and eye drops with 0.2 percent rebamipide.
Samjin is also working on “SJP002,” a new eye drop that earned approval from the Ministry of Food and Drug Safety in July for a phase-2 clinical trial. The company also confirmed the effectiveness of the multiplication of goblet cells in an animal test. With a new oral drug and a fresh eye drop, Samjin aims to enhance its expertise in dry eye treatments.
Hanall Biopharma is developing a new therapy for dry eye syndrome in the U.S. “HL-036” is a biobetter, an improved version of anti-TNF antibodies put in an eye drop format. The company is working with Daewoong Pharmaceutical to develop the drug jointly. “HL-036” received approval from the U.S. FDA for a phase-2 clinical trial in September. The company aims to complete the test by August 2018.
Hanall’s new drug candidate proved safety and partial drug tolerance through a phase-1 clinical trial at the Seoul National University Hospital. In September last year, the company licensed out technologies for the two drug candidates HL-036 and HL-161 to China’s HarbourBioMed for $81 million.
Kukje Pharma has also recently joined the fray. Despite internal concerns about the financial burden of investment, the recent winning of approval for a phase-1 clinical trial on a new dry eye treatment allowed the company to push ahead with its project in earnest.
Kukje’s treatment, called “HCS-001,” is sulfasalazine changed into an eye drop format that is effective on eye diseases, including retinal damage. Sulfasalazine is traditionally challenging to liquidize, but the firm made it into an eye drop by combining it with sodium hyaluronate.
The company hopes that the new drug can reduce the damage to epithelial cells on the cornea in dry eyes and treat the inflammation of the cornea.
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