Miscellaneous ocular agents:
Indications for: VUITY
Approval was based on data from the phase 3 GEMINI 1 (ClinicalTrials.gov Identifier: NCT03804268) and GEMINI 2 (ClinicalTrials.gov Identifier: NCT03857542) studies that evaluated the efficacy and safety of Vuity in a total of 750 patients aged 40 to 55 years with presbyopia. Patients were randomly assigned 1:1 to receive Vuity or vehicle, 1 drop once daily into each eye.
Results from the GEMINI 1 and GEMINI 2 studies showed that 31% and 26% of patients treated with Vuity, respectively, met the primary endpoint achieving 3-lines or more in mesopic, high contrast, binocular distance corrected near visual acuity, without losing more than 1 line (5 letters) of corrected distance visual acuity with the same refractive correction on day 30 at hour 3, compared with 8% and 11% of patients in the vehicle group (P <.01).
The treatment was found to work as early as 15 minutes and lasted up to 6 hours, as measured on day 30.
Instill 1 drop in each eye once daily; may administer a second dose (1 additional drop in each eye) 3–6hrs after the first dose.
Pre-existing retinal disease. Iritis: not recommended. Contact lenses: remove prior to use; reinsert 10mins after administration. Poor illumination: advise to avoid night driving, other hazardous activities. Pregnancy. Nursing mothers.
Separate with other topical ophthalmic products by at least 5mins apart.
Headache, conjunctival hyperemia; blurred vision; rare: retinal detachment, retinal tear.
Generic Drug Availability: