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YUVEZZI: Long-Term Safety and Side Effect Profile

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With established long-term safety, your patients can have confidence using YUVEZZI

BRIO II: The world’s largest and longest single Phase 3 safety study in presbyopia1
12-month
SAFETY STUDY1
358
PATIENTS1
~70,000
DOSING DAYS1
YUVEZZI was evaluated vs vehicle in 358 patients with presbyopia in a randomized double-masked controlled study (BRIO II) of up to 12 months’ duration.1

Most common treatment-related adverse events from 
BRIO II (reported in >5% of participants)2

 YUVEZZI
(N = 358)		Vehicle
(N = 159)
Headache56 (15.6%)1 (0.6%)
Eye irritation (upon instillation)50 (14.0%)1 (0.6%)
Eye pain (upon instillation)24 (6.7%)0 (0.0%)
Visual impairment23 (6.4%)1 (0.6%)

No overall differences in safety observed between adult and elderly patients1

*

YUVEZZI was evaluated in 536 patients with presbyopia in 2 randomized double-masked controlled studies. BRIO I was a single-dose crossover study in which 178 patients received YUVEZZI. BRIO II included 358 patients who received YUVEZZI in the long-term safety portion of the study (up to 12 months' duration). 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.1

No treatment-related serious adverse reactions through 12 months1*

The majority of adverse reactions were mild, transient, ​and self-resolving1

No observed retinal detachments through 12 months2

Treatment-related vitreous detachment was similar with YUVEZZI (0.8%) compared to vehicle (0.6%)2

Rare cases of retinal tear and detachment have been reported with miotics. Individuals with pre-existing retinal disease are at increased risk of retinal detachment. Examination of the retina is advised in all patients prior to the initiation of therapy1

Low treatment-related hyperemia with YUVEZZI2

Patients demonstrated less treatment-related hyperemia with YUVEZZI than with carbachol alone2

Patients experiencing hyperemia

Chart showing how treatment-related hyperemia side effects from YUVEZZI were lower than those from carbachol alone in clinical trials.

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Counseling recommendations prior to prescribing YUVEZZI

Patient counseling information1

 

YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients. For additional information, advise your patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

 

Night Driving

Patients should exercise caution when night driving, as YUVEZZI may cause temporary dim or dark vision.

 

Blurred Vision

Temporary problems when changing focus between near objects and distant objects may occur.

 

When to Seek Physician Advice

Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss.

 

Contact Lens Wear

Contact lenses should be removed prior to the instillation of YUVEZZI. Wait 10 minutes after dosing before reinserting contact lenses.

 

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

 

Avoiding Contamination of the Product

Patients should avoid touching the tip of the single-use vial to the eye or to any other surface.