Tyrvaya nasal spray has received FDA approval for the treatment of dry eye disease in the US.
This is the first and only nasal spray approved for the treatment of dry eye disease. The FDA approved Tyrvaya nasal spray for the treatment of signs and symptoms of dry eye disease, according to an October 18, 2021, press release from Oyster Point Pharma.
Tyrvaya (varenicline solution 0.03 mg), previously called OC-01, a new drug and a new delivery option for this condition, increases the production of tears and lubricates the eye surface.
“The approval of Tyrvaya nasal spray marks a milestone for patients and eye care professionals by providing a new drug treatment option for the signs and symptoms of dry eye disease with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose,” Jeffrey Nau, Ph.D., MMS, president and CEO of Oyster Point Pharma, said in the release.
TESTING OF TYRVAYA
The drug was investigated in three clinical trials in more than 1,000 patients at 22 sites in the United States. The trials showed that patients treated with Tyrvaya showed significant improvement in tear film production as assessed the Schirmer’s test which evaluates the amount of tears produced.
The average change in Schirmer’s score was 11.7 mm in the patients treated with TYRVAYA, as compared to 3.2 mm in the vehicle-treated patients in the ONSET-1 study at Week 4.
Transient neezing was reported in 82% of patients testing the drug. Other mild events, including cough, throat irritation, and nose irritation, were reported in 5% to 16% of patients.
HOW DOES TYRVAYA WORK?
“Tyrvaya increases both the quantity and the quality of tears, evidenced by the increase in the Schirmer score and the generation of all three layers of the tear film, as well as the 1,500 protein, mucin, and other molecules in the basal tear film.” says Marian Macsai, MD, Oyster Point Pharma’s chief medical officer and the former chief of ophthalmology for the NorthShore University Health, Chicago.
Tyrvaya promotes parasympathetic nervous system processes which transport the medication through the mucous membranes to the trigeminal nerve pathways and into the ophthalmic nerve, to stimulate the nicotinic receptors housed there. This in turn produces tears that lubricate the eyes.
HOW DOES TYRVAYA DIFFER FROM EXISTING DRY EYE TREATMENTS?
Restasis (cyclosporine ophthalmic) works by dampening the body’s immune response to irritation. It is administered by drops onto the eye.
Xiidra (lifitegrast ophthalmic) works as an anti-inflammatory for the eye. It is administered by drops onto the eye.
AVAILABILITY AND USAGE OF TYRVAYA
Tyrvaya will be available in the US in November 2021. The prescription will provide two multidose nasal spray bottles. Each bottle provides 15 days of treatment when sprayed twice daily into each nostril. Eye care providers will also receive samples that give 15 days of treatment.
“In any therapeutic area, it’s always an exciting moment when you follow the science and develop a truly innovative pharmaceutical treatment option for patients that addresses an important unmet medical need." Jeffrey Nau, of Oyster Point Pharma
SOURCES
Prescribing Information of TYRVAYA pdf
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