Jeffrey Nau, Oyster Point Pharma CEO
October 18, 2021 10:45 AM EDT PharmaFDA+
Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.
The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.
The candidate has been in clinical trials since 2018, just a year before Oyster Point went public with an $80 million IPO in 2019.
The most common adverse reaction reported in 82% of patients was sneezing — and other events that were reported in 5- 16% of patients were coughing; along with throat and nose irritation.
Ji Xing Pharma, a Shanghai biotech with Merck veteran Joe Romanelli at the helm, had already bought the rights in China, Taiwan, Hong Kong, and Macau to the compound, also known as OC-01, for $17.5 million upfront and 0.75% company equity in a $204.8 million biobucks deal in August. Oyster Point CEO Jeffrey Nau told Endpoints News that the company will retain global rights outside of those markets.
“We’ll assess what our plans are going forward. We’re focused on markets like Europe and Japan, where there’s a dry eye marketplace there that is quite interesting. We’ve engaged with regulators,” Nau said in an interview. “But at the moment, our focus is getting things launched here in the US. We’ve got our partnership in Greater China, and then we’ll continue to look at other global markets after that.”
The new product will be available with a prescription starting in November — to be administered twice daily in each nostril. Each treatment, which is two bottles, is 30 days of doses.
Tyrvaya’s approval for 0.03 mg of varenicline was only one of two dosages being investigated in Oyster Point’s clinical trials — the other dosage was 0.06 mg of varenicline, or double what was approved by the FDA.
Nau told Endpoints that Oyster Point was looking at the second dosage for another indication: the corneal degenerative disease neurotrophic keratopathy. That dosage of varenicline is currently in a Phase II study, which is expecting to have a readout by June of next year.
“So there’s a possibility that that dose does play in the US market eventually. But the decision here with FDA was both doses, you know, we consider both doses to be approvable. The FDA landed on the lower dose based on similar efficacy profiles, but obviously less exposure for patients at that lower dose,” Nau said.
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