JIXING Ophthalmology Product Varenicline Solution Nasal Spray Is Available at Boao Super Hospital in Hainan Province
Varenicline solution nasal spray is the first and only nasal spray approved by the U.S. FDA for the treatment of the signs and symptoms of dry eye disease
Stimulating natural tear film through nasal spray formulation, varenicline solution nasal spray may be a paradigm-changing way to treat dry eye disease
SHANGHAI, China, April 6, 2023 – Ji Xing Pharmaceuticals Limited (JIXING), a clinical-stage biopharmaceutical company committed to bringing innovative medicines to underserved Chinese patients with serious and life-threatening diseases, today announces that its ophthalmology product varenicline solution nasal spray (formally known as OC-01 nasal spray) is officially available at Boao Super Hospital in Hainan province. It is approved by Hainan Medical Product Administration as an imported drug for patients with urgent clinical needs. Varenicline solution nasal spray is the first and only nasal spray approved worldwide for the treatment of the signs and symptoms of dry eye disease.
“There are more than 200 million patients suffering from Dry Eye Disease in China. Current therapies only target distinct components of the dry eye cycle such as inflammation, instead of re-establishing a healthy tear film. Stimulating natural tear film through a nasal spray formulation, varenicline solution nasal spray may be a paradigm-changing way to treat dry eye disease.” said Professor Wei Chen, Director of International Optometric Eye Center of Boao Super Hospital and Deputy Director of the Optometry Department of Wenzhou Medical University. “Chinese dry eye patients will have early access to this innovative product supported by pilot policies for early access. This is another significant progress to accelerate the availability of cutting-edge ophthalmic technology to China.”
“We are very honored to cooperate with the International Optometric Eye Center of Boao Super Hospital to make varenicline solution nasal spray available while still undergoing the clinical development in 20 leading clinical centers across China. Leveraging pilot policies for early access in Boao, this is our first product to directly benefit patients in China. “said Kun Wu, Chief Commercial Officer of JIXING. “Varenicline solution nasal spray has already received New Drug Application approval in US and Macau SAR. We are committed to working closely with the government authorities and the medical community in China to further leverage pilot policies for early access to benefit more Chinese patients.”
Varenicline solution nasal spray is a highly selective cholinergic agonist which is being evaluated in a clinical trial in China for the treatment of the signs and symptoms of dry eye disease as a multidose preservative-free nasal spray. Varenicline solution nasal spray is designed to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. In October 2021, the U.S. FDA approved varenicline solution nasal spray for the treatment of the signs and symptoms of dry eye disease. It is the first and only nasal spray approved by the FDA for the treatment of the signs and symptoms of dry eye disease.
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 is a highly selective cholinergic agonist that is U.S. FDA approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the "rest and digest" system of the body, 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. The exact mechanism of action is unknown at this time.
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 China.
Contacts:
References:
- Wirta, D., Vollmer, P., Paauw, J., et al.& ONSET-2 Study Group. Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease: the ONSET-2 Phase 3, Randomized Trial. Ophthalmology 2021; -:1-9. https: //doi.org/10.1016/j.ophtha.2021.11.004.
- Wirta, D., Torkildsen, G. L., Boehmer, B., Hollander, D. A., Bendert, E., Zeng, L., ... & Nau, J. (2022). ONSET-1 phase 2b randomized trial to evaluate the safety and efficacy of OC-01 (varenicline solution) nasal spray on signs and symptoms of dry eye disease. Cornea.
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