YUVEZZI
Generic: CARBACHOL AND BRIMONIDINE TARTRATE
Basic Information
Manufacturer
Visus Therapeutics, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
68198098-0f33-458f-83b8-eb2a5ec69012
Indications & Usage
1 INDICATIONS AND USAGE YUVEZZI™ is indicated for the treatment of presbyopia in adults.
YUVEZZI is a combination of carbachol, a cholinergic agonist, and brimonidine, an alpha-adrenergic receptor agonist, indicated for the treatment of presbyopia in adults.
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YUVEZZI is a combination of carbachol, a cholinergic agonist, and brimonidine, an alpha-adrenergic receptor agonist, indicated for the treatment of presbyopia in adults.
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Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications (4) ] Most common adverse reactions (incidence >5%) are eye pain upon instillation, visual impairment, eye irritation upon instillation, and headache.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Visus Therapeutics, Inc., at 1-888-735-0821 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.
YUVEZZI was evaluated in 536 patients with presbyopia in two randomized, double-masked, controlled studies.
BRIO™ I (NCT05270863) was a single-dose crossover study in which 178 patients received YUVEZZI.
BRIO II (NCT05135286) included 358 patients who received YUVEZZI in the long-term safety portion of the study (up to 12 months duration, including a 6-month open-label extension).
Adverse reactions reported in > 5% to 7% of participants were eye pain upon instillation and visual impairment.
Adverse reactions reported in > 10% to 16% of participants were eye irritation upon instillation and headache.
The majority of adverse events were mild, transient, and self-resolving.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Visus Therapeutics, Inc., at 1-888-735-0821 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.
YUVEZZI was evaluated in 536 patients with presbyopia in two randomized, double-masked, controlled studies.
BRIO™ I (NCT05270863) was a single-dose crossover study in which 178 patients received YUVEZZI.
BRIO II (NCT05135286) included 358 patients who received YUVEZZI in the long-term safety portion of the study (up to 12 months duration, including a 6-month open-label extension).
Adverse reactions reported in > 5% to 7% of participants were eye pain upon instillation and visual impairment.
Adverse reactions reported in > 10% to 16% of participants were eye irritation upon instillation and headache.
The majority of adverse events were mild, transient, and self-resolving.