Drug Development, Results

Hoping to shake Allergan/Shire’s dry eye dominance, Oyster Point posts positive Phase IIb data for rival drug

Jeffrey Nau

When patients go to the eye doc complaining of dry, itchy eyes, they’re usually given some lubricating eye drops and perhaps a low-dose steroid to help with inflammation. Sometimes that’s enough to manage the discomfort. Sometimes it’s not, and docs will move on to prescribing drugs like Allergan’s Restasis or Shire’s Xiidra. But these drugs don’t provide fast relief. Sometimes they can take weeks, even months in Restasis’ case, to provide a therapeutic effect.

That window of opportunity is what Oyster Point is tackling with its drug OC-02, which just emerged from a Phase IIb trial with some promising results. The company’s drug is unique when compared with other prominent dry eye drugs, because it doesn’t go directly in the eye. It goes in the nose.

“Most of the market focused on dealing with one aspect of the disease, either applying an anti-inflammatory strategy or attempting to lubricate the ocular surface,” said Oyster Point’s CEO Jeffrey Nau. “The problem with both is that they’re not dealing with the underlying problem — there’s no stable tear film on the eye.”

Oyster’s nasal spray targets that underlying problem, stimulating the trigeminal parasympathetic pathway to activate the glands responsible for producing the eye’s natural tear film. OC-02, a nicotinic acetylcholine receptor agonist, was tested in 165 patients in the Phase IIb trial called Pearl.

The study put patients in an enclosed chamber for two hours, reduced the room’s humidity and made things quite uncomfortable for those involved.

“The environment was akin to putting you in the desert with wind blowing at you,” Nau said. “It’s not pleasant, even if you don’t have dry eye disease.”

After one dose of the nasal spray, patients showed a statistically significant improvement in the production of tear film and patient-reported symptoms — meeting both the sign and symptom primary endpoints Oyster had set out.

The company measured tear production by Schirmer’s score, which is a test of the eye’s ability to produce tears. All groups saw improvement, but the 2% dose saw the biggest change with a score of 19.3 mm compared to the control arm score of 2.6 mm (p<0.0001).

For the patient-reported symptoms endpoint, the trial used the Eye Dryness Scale to measure. The same dose saw a mean change in EDS score of -19.0 mm (p=0.0006 vs. -6.8 mm in control).

Nau said the company has to wrap up two more short 28-day trials by the end of this year, and plans to have a Phase II meeting with the FDA by December. If the Phase III trial goes as hoped and the FDA approval process takes a year, Nau said it could be 2021 before OC-02 reaches the market.

If the drug does reach the market, company execs believe it has the potential to cut into Allergan and Shire’s dominance in the dry eye sphere. Although Nau declined to discuss how much of the market Oyster estimates it can tackle, he did say they expect “a number of benefits for a broad patient population.”

“No matter which way you cut up the patient population, the statistical significance holds up,” he said.

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