JIXING Announces Receipt of Clinical Trial Application Approval for OC-01 Nasal Spray Phase 3 Trial for the Treatment of Signs and Symptoms of Dry Eye Diseases in China
OC-01 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
SHANGHAI, China, March 21, 2022 – 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, announces that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the PRC (NMPA) has approved the Clinical Trial Application (CTA) for the phase 3 clinical trial of OC-01 (varenicline tartrate) nasal spray for the treatment of signs and symptoms of dry eye disease (DED) in China.
OC-01 nasal spray (approved in the U.S. with the brand name of TYRVAYATM), developed by Oyster Point Pharma, Inc., is a highly selective cholinergic agonist indicated for the treatment of the signs and symptoms of DED as a multidose preservative-free nasal spray. In August 2021, JIXING entered into an exclusive license and collaboration agreement with Oyster Point Pharma to develop and commercialize OC-01 nasal spray for patients in Greater China. In October 2021, the U.S. Food and Drug Administration (FDA) approved OC-01 nasal spray for the treatment of the signs and symptoms of DED.
“Over 200 million people in China are impacted by dry eye disease. A comfortable, convenient, long-lasting treatment stimulating natural tear film production has the potential to trigger a treatment paradigm-shift of dry eye disease.” said Larry Li, MD, PhD, Chief Medical Officer of Ophthalmology at JIXING. “Receiving CTA approval to conduct the Phase 3 trial for OC-01 nasal spray demonstrates the demand for disruptive therapies in China and is one of the early steps in fulfilling our strong commitment to making innovative science available to Chinese patients with eye disease.”
The approved study is a Phase 3, multicenter, randomized, controlled, double-masked study designed to evaluate the efficacy and safety of OC-01 nasal spray in adult participants with DED. The subjects, at least 18 years of age with a physicians’ diagnosis of DED and meeting all other study eligibility criteria, will be randomized to receive an application of OC-01 or placebo (vehicle). The primary endpoint is the percentage of subjects who achieve ≥10mm improvement in Schirmer’s Test Score from baseline. Other efficacy measures include assessment of Eye Dryness Score and Corneal Fluorescein Staining.
Dry eye disease (DED) 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. DED 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 large unmet need in DED as current therapies only target distinct components of the dry eye cycle, such as inflammation instead of re-establishing a healthy tear film.
OC-01 (varenicline tartrate) 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 OC-01 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 Greater China.
Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. In October 2021, Oyster Point Pharma received FDA approval for TYRVAYATM (varenicline solution) Nasal Spray. Oyster Point has a growing pipeline of clinical and pre-clinical programs and continues to expand its research and development pipeline through internal innovation and external collaborations. Oyster Point is continuously striving to advance breakthrough science and deliver therapies seeking to address the unmet needs of patients with ophthalmic disease and the eye care professionals who take care of them. For more information, visit www.oysterpointrx.com and follow @OysterPointRx on Twitter and LinkedIn.
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