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 The company said the spray, Tyrvaya, will be available from next
month to patients with a prescription.
The regulator's decision was based on safety and efficacy results
from a late-stage and two mid-stage trials covering over 1,000
patients with mild, moderate or severe symptoms of dry eye disease (DED).
More than 30 million people in the United States are affected by the
chronic condition characterized by stinging, sensitivity to light,
blurred vision and eye fatigue.
Oyster Point in March said data from the trials showed that Tyrvaya
demonstrated statistically significant improvement in production of
tear film on eye surface in all trials.
Tear film helps to keep eyes moist, reducing risks of infection and
contributing to clear vision.
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 "A product that provides
clinically meaningful production of basal tear
film as early as four weeks is incredible for
the dry eye patient," Ed Holland, director of
cornea services at Cincinnati Eye Institute and
professor of ophthalmology at University of
Cincinnati said in the company's statement.
Tyrvaya is a nasal spray formulation of the drug
varenicline, also used in Pfizer Inc's smoking
cessation drug, Chantix.
Tyrvaya works by activating a nerve that
stimulates natural tear film production, and in
turn relieving symptoms of dry eye disease.
(Reporting by Leroy Leo and Manojna Maddipatla
in Bengaluru; Editing by Shinjini Ganguli)
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