VUITYTM has a well-established safety and tolerability profile.1

In the studies, there was a low discontinuation rate (1.3%) due to adverse events (AEs)2

1.3% Discontinued VUITY™ due to AEs2

(5/375) vs 0.5% vehicle (2/374)

0.5% Discontinued VUITY™ due to headache2

(2/375) vs 0.3% vehicle (1/374)

No
serious AEs
were
observed2

Most AEs were reported as mild and transient. in clinical trials.2

The majority of treatment-emergent adverse events (TEAEs) were deemed by the investigator to be mild in severity. TEAEs of moderate severity were reported for 4.0% of participants [15/375] in the VUITY™ group and 2.4% of participants [9/374] in the vehicle group. Severe TEAEs were reported for 1.1% [4/375] of participants in the VUITY™ group and 0.5% [2/374] of participants in the vehicle group.2

Rate of TEAEs in GEMINI 1 and GEMINI 2 (pooled data)1,2

Chart of treatment-emergent adverse events for VUITYTM

85% of VUITY™ participants in clinical trials didn’t experience headaches2

Most headaches were reported as mild and transient. Participants were asked if they experienced a headache and, if so, to rate its severity at every study visit.2

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Post-marketing data

Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITYTM. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to the initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss.1,3

The following adverse reactions have been identified during postapproval use of VUITYTM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to VUITYTM exposure. Eye disorders: vitreous detachment, vitreomacular traction, retinal tear, retinal detachment.1,3

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