Oyster Point Pharma’s nasal spray treatment for dry eye disease has met its primary endpoints in the phase 2 MYSTIC trial, CEO and President Jeffrey Nau, PhD, said at the J.P. Morgan Healthcare Conference.
OC-01 (varenicline) nasal spray is a selective nicotinic acetylcholine receptor agonist. The MYSTIC study evaluated the safety and efficacy of two doses (0.6 mg/mL and 1.2 mg/mL) of OC-01 in patients with dry eye. Subjects received twice-daily dosing of OC-01 over 84 days.
“When we look at the data over time, you see really consistent tear production starting at day 7 and going all the way through day 84 in both doses,” Nau said.
Patients who received the 1.2 mg/mL dose had a mean improvement of 11 mm in Schirmer’s score in their study eye and 10 mm in their fellow eye, according to an Oyster Point press release. Those who received the 0.6 mg/mL dose experienced a mean change of 10.6 mm in the study eye and 8.7 mm in the fellow eye. These results compared with a mean change of 6.2 mm and 4.5 mm in the vehicle control group.
During his presentation, Nau explained how Oyster Point’s nasal spray is designed to use more natural tear film, rather than artificial lubricant, in treating dry eye.
“When we think about the way we are treating dry eye disease, we think that the really fundamental, underlying theme here is that there is no substitute for natural tear film. It is highly complex. It’s made up of thousands of different proteins, multiple classes of lipids, mucins and growth factors,” he said. “It’s the way our body heals trauma to the ocular surface, and what we’re doing is trying to harness this natural tear film as the therapeutic.”
OC-01 is currently in phase 3 clinical trials, with results expected in mid-2020, and the company is planning to commercialize the product in the first quarter of 2021, pending approvals. – by Rebecca L. Forand
Nau J. Oyster Point corporate update. Presented at the J.P. Morgan Healthcare Conference; Jan 13-16, 2020; San Francisco.
Disclosure: Nau reports he is the president and CEO of Oyster Point Pharma.