Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS Blurred Vision : Advise patients not to drive or operate machinery if vision is not clear (e.g., blurred vision).
Exercise caution in night driving and other hazardous activities in poor illumination.
( 5.1 ) Risk of Retinal Detachment : Rare cases of retinal tear and detachment have been reported with miotics.
Individuals with preexisting retinal disease are at increased risk.
Therefore, examination of the retina is advised in all patients prior to initiation of therapy.
Like all medications, Yuvezzi can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: