Oyster Point, with AbbVie and Novartis in its sights, wins first FDA approval for nasal spray to treat dry eye disease

Oyster Point Pharma’s bet that the path to a better dry eye disease treatment goes through the nose has come good, with the FDA approving its Tyrvaya for use in a broad population of patients.

Currently, physicians treat dry eye disease using eye drops such as AbbVie’s Restasis and Novartis’ Xiidra. While getting drugs to the eye to treat the eye is the most obvious approach, Oyster Point saw evidence it may not be the best approach. Rather, Oyster Point wagered that activating a nerve in the nose can trigger the production of tears in the eye and improve on existing treatment options. 

The FDA is convinced by the data Oyster Point generated to support the hypothesis, leading it to make Tyrvaya the first nasal spray approved in the treatment of dry eye disease in the U.S. The label covers the use of Tyrvaya in adults with mild, moderate or severe dry eye disease. John Snisarenko, chief commercial officer at Oyster Point, set out the opportunity on a conference call with investors.

“There have been almost 7 million patients that have tried and abandoned the current therapies. So, a lot of patients are waiting for something new. They abandoned it maybe because the products take too long to work, they have ocular side effects or they can't even take eye drops,” Snisarenko said.

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Oyster Point landed the approval on the strength of three clinical trials that enrolled more than 1,000 patients. The two key studies found around half of patients who received Tyrvaya cleared the bar for increased tear production, compared to 14% and 28% of subjects in the control groups. The most common adverse reaction was sneezing, which affected 82% of patients.

Having landed the approval, Oyster Point plans to make Tyrvaya available next month. Oyster Point is aiming to have a patient services program in place from day one to bridge the gap until commercial insurers come on board. Out-of-pocket expenses for patients who are insured but not covered will be around $10, falling to as low as zero for patients who are covered. Snisarenko, who previously worked on Xiidra, set out the other elements of Oyster Point’s launch strategy.

“This market is very promotionally sensitive. Patient education is going to be a key part of the launch. I think that both leaders in this space, Xiidra and Restasis, have done a great job at educating and driving that market. And we're going to be very competitive—our sales force side is going to be very competitive with the leaders, as well as our initial investment in that direct-to-patient education,” Snisarenko said.