On August 5, Oyster Point Pharma, Inc. revealed on its official website that it has reached a cooperation agreement with Ji Xing Pharmaceuticals, which will develop and commercialize OC-01 (varenicline) and OC-02 (simpinicline) nasal sprays for patients with dry eye disease in Greater China region. Oyster Point Pharma will obtain a down payment of 17.5 million US dollars, a potential development and sales-based milestone payment of up to 204.8 million US dollars, and a layered franchise usage fees based on future net sales. Ji Xing Pharmaceuticals plans to produce OC-01 and OC-02 in China, and bear the costs of development and commercialization in the licensed area.
Dry eye disease is a chronic eye disease that more than 30 million people in the United States and more than 150 million people in China are suffering from it. Patients with dry eye disease will find eye discomfort and inflammation due to the damaged tear film in their eyes. Damaged tear film may result from reduced tear production, imbalance of tear elements or excessive evaporation of tears.
There are two main types of dry eye disease:
The first one is the aqueous tear deficiency. The tear secretion decreases but evaporates normally. It can be divided into drying type or non-drying type according to whether there is Sjögren syndrome. The latter is more common.
The second one is the evaporative dry eye, which means tears secretes normally but evaporates excessively. It mainly results from the meibomian gland dysfunction (MGD) and accounts for 80% patients with dry eye disease.
Regardless of the type, eye discomfort and pain caused by dry eye disease will reduce the life quality of patients and make them have difficulties in reading, driving, using computers or carrying out other daily activities. The number of patients with dry eye disease is huge and their disease burden is heavy. Therefore, there is an obvious unmet need for effective treatment.
OC-01 nasal spray is a preservative-free, and highly selective cholinergic agonist nasal spray packaged in multiple doses. It is used to treat symptoms and physical signs of dry eye disease and neurotrophic keratopathy. In the preclinical and clinical studies, OC-01 is given as a preservative-free aqueous nasal spray, which can activate trigeminal parasympathetic pathway in nasal cavity and thus activate the natural tear film secretion.
OC-02 (simpinicline) is a highly selective cholinergic agonist nasal spray. Simpinicline citrate is a strong nicotinic acetylcholine receptor agonist, which has activity on receptors α4β2, α3β4, α3α5β4 and α4α6β2 and weak activity on receptor α7. Two phase IIb clinical trials against dry eye disease has been previously completed on OC-02.
At present, the main traditional method for treating dry eye disease is to use artificial tears, such as sodium hyaluronate and carboxymethylcellulose sodium. They have the same viscosity and flexibility as biological tears, and can mitigate clinical symptoms such as eye drying, pain, itching, burning sensation and foreign body sensation, but they cannot eradicate the cause. Other drugs shall be combined to reduce the severity of the disease for moderate and severe patients with dry eye disease.
Anti-inflammatory treatment is the mainstream for drugs under research at home and abroad. At present, many pharmaceutical companies in China have developed their own drugs for dry eye disease or introduced targeted drugs from abroad, in which the CyclASol (0.1%, cyclosporine A preparation) introduced by Hengrui Medicine from Novaliq, SkQ1 eye drops (inhibitor of cardiolipin peroxidation) introduced by Essex Bio-Technology from Mitotech, RGN-259 (sterile and preservative-free new therapeutic peptide eye drops with thymosin β4 as active ingredient) introduced by Lee's Pharm from RegeneRx Company, etc. All of these are targed at anti-inflammatory treatment. If you are looking for active pharma ingredients, then Pharmasources would be your first choice.
Xiidra (Novartis), Eysuvis (Kala) and Refresh (Abbvie/Allergan) are undoubtedly potential varieties in the field of dry eye...
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