Oyster Point Pharma’s OC-01 (varenicline) drug is unlike any other dry eye treatment on the market and could provide long-term relief for sufferers of dry eye disease.
Dry eye disease is a chronic condition affecting an estimated 340 million adults globally, and an estimated 34 million adults in the United States. Despite the prevalence of this condition and its significant influence on an individual’s quality of life, there are still very few effective therapies available to improve the signs and symptoms of dry eye disease.
Currently, there only four FDA approved medications for dry eye disease: Restasis (cyclosporine), Xiidra (liftegrast), Cequa (cyclosporine), and Eysuvis (loteprednol etabonate), a steroid recently approved for short-term treatment of dry eye disease. Considering the limited options and list of side-effects for each of the available treatments, many of those suffering with chronic dry eye disease are unable to effectively treat their condition – which can be both mentally and physically debilitating.
Limited treatment options for sufferers of dry eye disease have left many unable to work, drive, or enjoy daily activities.
However, there is reason to be hopeful for future dry eye disease treatments. Since 2018, Oyster Point Pharma, a clinical-stage biopharmaceutical company focusing on ocular surface diseases, has been testing and developing their novel dry eye disease medication, OC-01 (varenicline) with great success. OC-01 is a highly selective nicotinic acetylcholine receptor (nAChR) agonist, and is being developed as a preservative-free nasal spray to treat dry eye disease.
Oyster Point Pharma’s research suggests that the parasympathetic nervous system (“rest and digest”) controls natural tear film production via the trigeminal nerve, which is accessible within the nose. The nAChR receptors are located on the trigeminal nerve and can be activated by Oyster Point Pharma’s OC-01 medication. This activation can subsequently engage the parasympathetic nervous system, stimulating the body’s own meibomian glands, lacrimal glands, and goblet cells to establish a natural, healthy tear film. This is truly a revolutionary dry eye treatment.
The human tear film is intricately arranged and comprised of over 1,500 different proteins, growth factors, lipids, mucins, and antibodies. This is why it can be so difficult to treat dry eye disease, where existing treatments such as artificial tears are unable to effectively replicate the complex tear film. Oyster Point Pharma’s novel approach to dry eye disease treatment, which has been shown to help stimulate the body’s own natural tear production to re-establish tear film homeostasis is incredibly exciting for those suffering from dry eye. Furthermore, since it is administered nasally, OC-01 may be more tolerable for those who have difficulty administering eye drops on a regular basis.
After three successful multicenter, randomized, double-masked, vehicle-controlled trials (ONSET-1, MYSTIC, ONSET-2) in over 1,000 subjects – all of which met the primary endpoint, Schirmer’s Score, a quantifiable measure of natural tear production – Oyster Point Pharma’s New Drug Application for OC-01 was approved by the FDA on March 2nd, 2021. Oyster Point Pharma’s PDUFA (Prescription Drug User Fee Act) is expected on October 17th, 2021, and the commercial launch of OC-01 could happen by the end of this year. This means that patients suffering from dry eye disease could be receiving this medication in the next three months.
Oyster Point Pharma is anticipating a commercial launch of OC-01 by the end of 2021.
OC-01 has the potential to provide relief for a significant amount of people suffering from dry eye disease, and could be an important addition to a patient’s existing dry eye disease protocol. Let’s hope Oyster Point Pharma receives good news from the FDA soon, and that medical professionals can begin prescribing this medication to patients in need. For more information on Oyster Point Pharma’s research and development, visit oysterpointrx.com