The Pharmaceutical Company Licenses in Two New Drugs for Dry Eye Disease with over 200 Million US Dollars

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 disease, with estimated sales of 844 million US dollars, 692 million US dollars and 404 million US dollars respectively by 2024, ranking the top three in the international market. However, the sales of Restasis (Abbvie/Allergan) have dropped sharply from blockbuster level to about 100 million US dollars in 2024 with the generic drugs eroding its sales after the patent expires. 

In the current, most pharmaceutical companies aiming at dry eye disease are actively building pipelines through cooperative research and development or introduction. By cooperating with local companies in different countries and regions that have established mature commercial promotion and sales channels in the field of ophthalmology, they can develop new products that can be commercialized to the greatest extent in a short time in the markets of specific countries. 

As a high-incidence disease, it is estimated that by 2024, the number of moderate and severe patients with dry eye disease in China will increase to 85.7 million, and will further increase to 93.7 million by 2030. Nowadays, with the increasingly rapid pace of life and working pressure, irregular work and rest schedule and serious lack of sleep have become the normality for many people. What's more, the long-term use of computers and contact lenses will cause and further aggravate the symptoms of dry eye disease.

The above factors are making the dry eye disease in China an increasingly serious problem, and the number of dry eye patients is expected to continue to rise at a faster rate. The dry eye disease shall be treated immediately. Otherwise, it will deteriorate into an intractable one, which thus causes keratitis and corneal ulcer, and results in decreased vision and even blindness. Therefore, we expect that there will be more self-developed or authorized introduced new and effective products in this field for patients. 

Reference: 

1.Oyster Point Pharma官网；

1.Oyster Point Pharma Official Website；

2.Retrieved Aug 06, 2021, fromhttps://www.prnasia.com/story/328415-1.shtml.

About  the Author:    

Yefenghong

Ye  Fenghong, a medical editor specializing in oncology at a healthcare internet  company, has conducted in-depth research on the pathogenesis and clinical  treatment of lung cancer and breast cancer. She has previously been involved  in the design and synthesis of anti-tumor drugs and has some experience in  computer-aided drug design. She is currently devoted to introducing  cutting-edge cancer treatment drugs to a wide range of readers, aiming to  help more people avoid cancer pain and embrace good health.