VUITY (pilocarpine hydrochloride)

Systemic exposure to pilocarpine was evaluated in 22 participants with presbyopia who were administered 1 drop of VUITY in each eye once daily for 30 days (GEMINI 1). The mean (SD) C max and AUC values from time 0 to last measurable concentration over 10-hour period post-last dose on Day 30 were 1.95 (0.98) ng/mL and 4.14 (2.16) ng·hr/mL, respectively. The median T max value on Day 30 was 0.3 hours postdose with a range from 0.2 to 0.5 hours postdose. Systemic exposure to pilocarpine was also ev...

The efficacy of VUITY dosed once daily for the treatment of presbyopia was demonstrated in two 30‐Day Phase 3, randomized, double‐masked, vehicle‐controlled studies, namely GEMINI 1 (NCT03804268) and GEMINI 2 (NCT03857542). A total of 750 participants aged 40 to 55 years old with presbyopia were randomized (375 to VUITY group) in two studies and participants were instructed to administer one drop of VUITY or vehicle once daily in each eye. In both studies, the proportion of participants gaining 3 lines or more in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA), ...

The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications ( 4 )] Most common adverse reactions (>5%) are headache, conjunctival hyperemia, and eye irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 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 i...

VUITY is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity ( 4 )

Blurred Vision : Patients should be advised 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 D etachment : Rare cases of retinal detachment and retinal tear have been reported with miotics, including VUITY. Individuals with pre-existing retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiati...