13 December 2023

JIXING’s Milestone! The University of Hong Kong - Shenzhen Hospital issued the first prescription for Varenicline Solution Nasal Spray

Varenicline Nasal Spray is the first dry eye product introduced into designated medical institutions in the Greater Bay Area, offering a new treatment option for dry eye patients in the Greater Bay Area and enabling them to truly return to a healthy and natural life

On December 13, 2023, Varenicline Solution Nasal Spray (US brand name TYRVAYA®) for the treatment of the signs and symptoms of dry eye disease (DED) was prescribed for the first time in the Greater Bay Area at the University of Hong Kong - Shenzhen Hospital. Varenicline Nasal Spray is the first dry eye product   introduced into designated medical institutions in the Greater Bay Area through the "Hong Kong and Macau Medicine and Equipment Connect" policy and approved by the Guangdong Provincial Drug Administration. The introduction of Varenicline Nasal Spray offers a new treatment option for dry eye patients in the Greater Bay Area. 

The first prescription of Varenicline Nasal Spray was issued at the University of Hong Kong - Shenzhen Hospital

As the first and only nasal spray approved to treat the signs and symptoms of dry eye disease in the US, Varenicline Nasal Spray has a unique mechanism of being administered through the nose and is designed to activate the trigeminal parasympathetic pathway which is believed to increase natural tear production.

Director of the Department of Ophthalmology at the University of Hong Kong - Shenzhen Hospital, REN Yalin, explained that tear film instability and lack of tears are the core mechanisms for the occurrence of dry eye disease, and that artificial tears are currently the first line treatment for dry eye disease. "However, natural tears contain more than 2,000 molecules, while currently developed artificial tears can only mimic one or more components of the tear film. It can be said that there is no true artificial substitute for natural tears. Varenicline Nasal Spray can promote natural tear secretion and it helps to stabilize the tear film more efficiently, which in turn helps to improve the dry eye treatment in China."

"JIXING is committed to bringing world-class innovative treatments to patients with eye disease in China. We believe that Varenicline Nasal Spray can bridge the gap of current dry eye treatments and enable dry eye patients in the Greater Bay Area to truly return to a healthy and natural life." said Sandy Mou, Board Executive Director and Chief Executive Officer of JIXING.

The first prescription for Varenicline Nasal Spray in the Greater Bay Area benefits from the "Hong Kong and Macau Medicine and Equipment Connect" policy. Varenicline Nasal Spray has been previously available at Bo'ao Super Hospital in Hainan province as an imported drug for patients with urgent clinical needs since April, 2023. The new listing in Greater Bay Area represents an important milestone in JIXING's commercialization progress in China. 

In July 2023, the Center for Drug Evaluation of the National Medical Products Administration accepted the new drug application of Varenicline Nasal Spray.

"We hope that Varenicline Nasal Spray will be approved in China as soon as possible, so that all of the nearly 300 million dry eye patients in China can benefit from the innovative therapy as soon as possible." Sandy Mou said.

Additional information

Dry eye disease is a chronic condition that is estimated to impact more than 200 million patients in China and is growing in prevalence, significantly influencing a person’s day-to-day quality of life. It can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue.  Dry eye disease is a multifactorial disease of the ocular surface characterized by disruption of the tear film. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. Natural tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components, and creates a smooth surface that forms the primary refractive surface of the eye. Despite the large prevalence and a significant disease burden, there remains a large unmet need in dry eye disease.

Varenicline solution nasal spray (US brand name TYRVAYA®)  is a highly selective cholinergic agonist that is U.S. FDA approved to treat signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of varenicline solution nasal spray in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors. 

TYRVAYA® is a registered trademark of Oyster Point Pharma, Inc., a Viatris company. 

JIXING is a biopharmaceutical company headquartered in Shanghai committed to bringing innovative science and medicines to underserved patients in China with serious and life-threatening diseases. Backed by RTW Investments, LP, JIXING was founded in 2019 and partners with global biotechnology companies to develop and commercialize novel, innovative therapeutics to treat unmet medical needs in cardiovascular and ophthalmic diseases. With a strong and further developing asset pipeline, seasoned management team, and patient-centric focus, JIXING is dedicated to delivering a meaningful and lasting impact on patients in Greater China. 

JIXING’s cardiovascular portfolio includes 3 assets in late-stage clinical development (aficamten, etripamil, omecamtiv mecarbil) and 1 in pre-clinical stage (JX09). JIXING’s ophthalmology portfolio includes 4 assets in late-stage clinical development (varenicline solution nasal spray/US brand name TYRVAYA, OC-02 nasal spray, JX06/LNZ100, JX07/LNZ101) and 1 asset in pre-clinical stage (JX08). For further information about JIXING, please visit www.jixing.com .

Contacts:

Media Contact

Ji Xing Pharmaceuticals

References:

  • Tyrvaya. Prescibing Information. Oyster Point Pharma; 2021.
  • Wirta D, Torkildsen GL, Boehmer B, et al. Cornea. 2021; 00(0)1-10.
  • Wirta D, Vollmer P, Paauw J, et al. Ophthamology. 2021:6420(21).
  • Oyster Point Pharma. Data on file. OPP-002(ONSET-1) Clinical Study Report. August 4, 2019.
  • Oyster Point Pharma. Data on file. OPP-101(ONSET-2) Interim Clinical Study Report. October 13, 2020.
  • Quiroz-Mercado H, Hernandez-Quintela E, Chiu KH, Henry E, Nau JA. Ocul Surf. 2022; 24:15-21.
  • Craig JP, Downie LE. Tears and Contact Lenses In: Phillips AJ, Speedwell L, eds. Contact Lesens. 6th ed. Elsevier; 2019:97-116.
  • Aaron M, Solley WA, Broocker G. General Eye Examination. In: Palay DA, Krachmer JH, eds. Primary Care Ophthalmology. 2nd ed. Mosby; 2005:1-23.
  • Akpek EK, Amescua G, Farid M, et al. Ophthalmology. 2019; 126(1):P286-P334.
  • Oyster Point Pharma. Data on file. OPP-004(MYSTIC) Clinical Study Report. March 19, 2020.
  • 晏晓明, 中华实验眼科杂志,2019年3月第37卷第3期.
  • Song P, Xia W, Wang M, et al. Variations of dry eye disease prevalence by age, sex, and geographic characteristics in China: a systematic review and meta-analysis. Journal of global health (2018); 8(2):020503.
  • Liu, Ning-ning, et al. Prevalence of and Risk Factors for Dry Eye Symptom in Mainland China: A Systematic Review and Meta-Analysis. Journal of Ophthalmology (2014); 2014(3):748654–8.
  • Jie Y, Xu L, Wu YY, Jonas JB. Prevalence of dry eye among adult Chinese in the Beijing Eye Study. Eye (Lond) (2009); 23(3):688-93.
  • 亚洲干眼协会中国分会等,中华眼科杂志,2020, 56: 418-422.
  • 中新社:眼科药品酒石酸伐尼克兰鼻喷雾剂上市申请获国家药品监督管理局受理
    https://www.sh.chinanews.com.cn/yljk/2023-07-17/114125.shtml
  • Lam SM, Tong L, Duan X, et al. J Lipid Res. 2014; 55(2):289-298.
  • Dart DA, Willcox MDP. Exp Eye Res. 2013; 117:1-3.
  • Willcox MSP Argueso P, Georgiev GA, et al. Ocul Surf. 2017; 15(3):366-403.
  • Guo OD LW, Akpek E., Turk J Med Sci. 2020; 50(SI-2):1611-5.
  • Hossain P, Siffel C, Joseph C, Meunier J, Markowitz JT, Dana R. BMJ Open. 2021; 11(3):e039209.
  • Dana R, Meunier J, Markowitz JT, Joseph C, Siffel C. Am J Ophthalmol. 2020;216:7-17.
  • McDonald M, Patel DA, Keith MS, Snedecor SJ. Ocul Surf. 2016;14(2):144-67.
  • Wang MT, Muntz A, Wolffsohn JS, Craig JP. Clin Exp Optom. 2021;104(8):835-40.
  • Vicario-de-la-Torre M, Caballo-Gonzalez M, Morales-Fernandez L, et al. Polymers (Basel). 2018; 10(4):1-13