XDEMVY
Generic: LOTILANER OPHTHALMIC SOLUTION
Basic Information
Manufacturer
Tarsus Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
ccd9e37c-654e-4e84-8c85-6523457df979
Indications & Usage
1 INDICATIONS AND USAGE XDEMVY is indicated for the treatment of Demodex blepharitis.
XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.
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XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.
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Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reaction was instillation site stinging and burning (10%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies 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.
XDEMVY was evaluated in 833 patients with Demodex blepharitis in two randomized, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2) with 42 days of treatment.
The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients.
Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals at 1-888-421-4002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies 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.
XDEMVY was evaluated in 833 patients with Demodex blepharitis in two randomized, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2) with 42 days of treatment.
The most common ocular adverse reaction observed in controlled clinical studies with XDEMVY was instillation site stinging and burning which was reported in 10% of patients.
Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis.