Oyster Point Pharma announced that the FDA has cleared the company’s investigational new drug (IND) application to proceed with clinical development of OC-01, an investigational compound intended to stimulate natural tear film production in people with dry eye disease that is administered with a nasal spray.
This regulatory milestone will support the company’s ongoing phase 2 clinical trials evaluating the safety and efficacy of two different nicotine acetylcholine receptor (nAChR) agonists – OC-01 and OC-02 – as potential treatments for the signs and symptoms of dry eye disease. A phase 2 trial of OC-02, which received IND clearance in October of 2017, was recently completed and data will be presented at an upcoming medical meeting.
“Our innovative pharmaceutical approach leverages the parasympathetic nervous system by stimulating the glands responsible for producing natural tear film. Delivered through a nasal spray, as opposed to traditional eye drops, this therapy has the potential to immediately reduce the symptoms of dry eye. Clearance of our IND application for OC-01 allows us to quickly advance this therapy into phase 2 clinical trials,” Dr. Jeffrey Nau, CEO of Oyster Point, said in a company news release. “We look forward to continuing phase 2 clinical trials for both drug candidates, OC-01 and OC-02, and sharing the results of multiple studies over the course of the year.”
OC-01 and OC-02 come from a class of drugs called nicotine acetylcholine receptor (nAChR) agonists that are known to affect the parasympathetic nervous system. The trigeminal nerve provides parasympathetic control of the glands that produce the eye’s natural tear film. Oyster Point is the only company developing a pharmaceutical approach to treating dry eye disease by stimulating the trigeminal parasympathetic pathway to promote natural tear film production. These compounds are being developed in a nasal spray to deliver them directly to the trigeminal nerve, which is accessible within the nose.