China’s Professor Lixin Xie Leads Dry Eye Treatment Study at Qingdao Eye Hospital

Professor Lixin Xie, a member of the Chinese Academy of Engineering, led a dry eye treatment study at the Qingdao Eye Hospital. The treatment, known as HBM9036, was led by a Chinese sponsor known as Harbour Biomed—a partner to Korean venture HanAll Biopharma. The Chinese firm has conducted two clinical trials now.

The Study

Professor Xie sought to test the efficacy and safety of the treatment in 100 patients with dry eye syndrome by applying HBM9036 0.25 % or placebo twice daily for eight weeks. The eye drops purportedly improved the signs of dry eye symptoms (corneal damage) before and after exposure to the arid environment, set as the primary endpoint of the study. The study results aligned with the results of HanAll’s U.S. VELOS-1 Study updated in April 2019. In that Phase III study, the Korean venture HanAll and Daewoong Pharmaceuticals conducted included 630 patients with dry eye disease at 11 clinical sites across America.

HanAll claims that the study reaffirmed the safety and tolerability of the drug—Harbour Biomed will discuss the data “at an international conference in the future.”  TrialSite News was not able to confirm the results of the VELOS-1 study but can share that the Principal Investigator for that study was Gail Torkildsen, MD, Andover Eye Associates.

Professor Xie Comments

Professor Xie noted, “Dry eye syndrome is complex and difficult to diagnose disease that has now a significant impact on the patient’s life.” He continued, “Recent studies show that dry eye patients are on the rise due to aging, increased use of smartphones, and the spread of fine dust.” He noted that HBM9036’s mechanism of action in the eye through tumor necrosis factor receptor 1 (TNFR1) “could be an innovative approach” reports Korea Biomedical Review. Xie concluded that clinical trial results thus far would support a more mature Phase III design and ultimately more hope for dry eye patients in China.

Dry Eye Disease in China—Big Potential Market

Dry eye disease in China affects hundreds of millions of people, as reported in Healio back in March 2019. On a trip there last year, Dr. Gupta “was amazed at how many patients there (China) suffer from dry eye.” She noted, “One hospital I visited sees 1 million outpatient visits each year, and many of these patients suffer from dry eye and meibomian gland dysfunction.” She reported the total patient number could be 194 million but many more could be underdiagnosed.

Harbour Biomed and HanAll Biopharma

In 2017, the Korean venture HanAll Biopharma inked a deal with Harbour Biomed to develop two novel biologic therapies in greater China for $81 million. The deal included the investigational dry eye disease therapy.

Lead Research/Investigator

Professor Lixin Xie, a member of the Chinese Academy of Engineering, is a famous Chinese expert in ophthalmology. He recently visited the Eye Institute and is honorary president of the Eye institute of Shandong Province.

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