Large pharmaceutical companies dominate the dry eye disease space – Allergan (NYSE:AGN) rakes in more than a billion dollars every year for its Restasis eye drops.

Eight-person Oyster Point Pharma wants in on that market. But it’s betting on a completely different approach.

“What we’ve come up with is a very innovative nasal spray, which when sprayed into the nose penetrates the naval cavity quite rapidly, binds to the [nicotinic acetylcholine] receptors, and can actually stimulate the patient’s natural tear production,” CEO Jeffrey Nau told Drug Delivery Business News. “It’s really the first of its kind in the pharmaceutical field to use this class of drugs to stimulate those receptors on the trigeminal nerve.”

Early data have been promising, the chief executive said. Oyster Point today touted data from a dose-ranging Phase IIb study showing that its nasal spray demonstrated a statistically significant reduction in the signs and symptoms of dry eye disease compared to a control spray.

The nasal spray sends Oyster Point’s nicotinic acetylcholine receptor agonist directly to the point where the nasal cavity connects to the eye – along the trigeminal parasympathetic pathway. There, the drug binds to nicotinic acetylcholine receptors and triggers natural tear production, Nau explained.

Eye drops, like Allergan’s Restasis product, are the standard of care for dry eye disease. But Nau noted that topical drug delivery to the eye isn’t always ideal for patients.

“If you’re a dry eye patient or you’re a patient that just underwent surgery or you’re a patient that wears contact lenses, delivering drugs by a drop or two to the front of the eye has a number of different challenges,” he said. “So delivering through any other novel mechanism is really exciting because we can spare the ocular surface. We don’t have to worry about whether the drug is sticking to the contact lenses. We don’t have to worry about whether this drug stings the surface of the eye. If you’re a dry eye patient who already has some discomfort, the last thing you want to do is put a drop on your eye that stings.”

Nasal sprays, like eye drops, are usable and familiar to most people, he added.

“Most patients through the course of their life, whether in childhood or early adulthood, have experience with a nasal spray somewhere along the way, whether it be for sinus congestion or allergies. So for most of us, nasal sprays are not foreign. I think that technology now with delivering nasal sprays provides a very comfortable mist in the nose, and one of the nice things about our product is you don’t have to get lots of drugs deep into the nose because we’re not treating a disease which is located back in the sinus cavity,” Nau said.

In the company’s latest, 165-person study, researchers saw a positive correlation between the dose of drugs and tear film production. They also correlated treatment with Oyster Point’s nasal spray with a reduction in symptoms.

“As far as we know, this is the first drug that’s ever been able to show not only an increase in tear production but a decrease in a patient’s symptoms that’s directly correlated to the dose of drug that they were given,” Nau said.

To stand up against a powerhouse company like Allergan, Nau explained that Oyster Point has taken a more direct attempt at treating dry eye disease.

“Most of the other therapies that are out there are not necessarily addressing the fundamental root cause of dry eye disease, which is the instability or the breakdown for that tear film tri-layer. They’re going after really what I would characterize as the sequelae of the disease, which is once that tear film layer breaks down, you get inflammation, you get irritation – that’s really downstream,” Nau said.

“What sets us apart is we’re actually stimulating the patient to produce their own natural tear film. What we hope to do is not only bring those patients that have dry eye disease back to a healthy state, but we hope to also stop those patients from moving down this disease continuum and getting into that chronic dry eye disease state because we’re able to put tear film that’s healthy and stable on their eye a number of times a day,” he added.

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