FDA Accepts NDA for Oyster Point’s Dry Eye Therapy OC-01
Eye disease company Oyster Point announced the New Drug Application (NDA) for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.
The U.S. Food and Drug Administration (FDA) has promised a decision by October, and the company is planning a product launch in Q4 of this year, if approved. FDA is not planning an advisory committee review.
Oyster Point is aiming for a growing dry eye disease market valued at $5.4 billion in 2019. According to the company, intranasal spray OC-01 has a unique mechanism of action, agonizing the nicotinic acetylcholine receptor (nAChR) in the parasympathetic nervous system to stimulate tear production.
OC-01 is also entering Phase II testing for patients with neurotrophic keratopathy, a rare degenerative corneal disease. The trial is expected to start in the first half of 2021.
The company says OC-01 may also have applications beyond those indications, such as for contact lens users and patients preparing for refractive surgery.
Existing therapies for dry eye disease include immunosuppressants like Restasis and Cequa, and anti-inflammatory therapies Xiidra, all delivered via eye drops. But even on regular treatment, flareups can still occur, and last year FDA approved Kala Pharmaceuticals’s corticosteroid Eysuvis for short-term treatment of dry eye disease.
Oyster Point estimates that about 13 million out of 16 million diagnosed dry eye disease patients are willing to try a new treatment.
Oyster Point has not yet published full data from ONSET-2, its Phase III trial of 758 patients receiving OC-01 or vehicle. However, in topline data announced last May, dry eye disease patients receiving either the 0.6 mg/ml or 1.2 mg/ml doses of OC-01 met the primary endpoint, a 10 mm-increase in a measure of tear film production, compared with the control group.
Secondary endpoints were mixed, with the higher dose only hitting statistical significance on an Eye Dryness Score benchmark, and both missed on patient-reported symptoms of eye dryness in the Controlled Adverse Environment. The company did not report any issues with drug tolerance or drug-related adverse events.
All told, OC-01 has been tested for safety and efficacy in over 1,000 patients to date.
In February, Oyster Point disclosed in its year-end financials that it had $192.6 million cash on hand, reflecting an increase over 2019 due to a $112.6 million follow-on equity offering in 2020. The company’s stock rose more than 3% to $21.57 on news of FDA’s acceptance.