TRYPTYR
Generic: ACOLTREMON
Basic Information
Manufacturer
Alcon Laboratories, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
2b7715a1-035c-4002-b582-5238efee5d58
Indications & Usage
1 INDICATIONS AND USAGE TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease.
TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.
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TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.
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Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reaction was instillation site pain (50%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc.
at 1-800-757-9780, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States.
The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%).
Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc.
at 1-800-757-9780, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States.
The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%).
Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.