United States Food and Drug Administration (FDA) Approves VUITY™ (pilocarpine HCI ophthalmic solution) 1.25%, the First and Only Eye Drop to Treat Presbyopia (Age-Related Blurry Near Vision).
Presbyopia, known as age-related blurry near vision, is a common and progressive eye condition that reduces the eye’s ability to focus on near objects and usually impacts people after age 40. In a non-presbyopic eye, the clear lens behind the iris can change shape and focus light to the retina, making it easier to see things up close. In a presbyopic eye, the clear lens hardens and does not change shape as easily, making it difficult to focus on near objects.
VUITY Eyedrop for Presbyopia
VUITY is a daily, prescription eye drop that works in as early as 15 minutes and lasts up to 6 hours, as measured on day 30, to improve near and intermediate vision without impacting distance vision. Specifically designed for presbyopia, VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, delivered with pHast™ technology. The proprietary pHast™ technology allows VUITY to rapidly adjust to the physiologic pH of the tear film. VUITY uses the eye’s own ability to reduce pupil size, improving near vision without affecting distance vision.
The FDA approval of VUITY is based on data from two pivotal phase 3 clinical studies, GEMINI 1 and GEMINI 2, which evaluated the efficacy, safety and tolerability of VUITY for the treatment of presbyopia. In both studies, VUITY met the primary endpoint, reaching statistical significance in improvement in near vision in low light (mesopic) conditions without a loss of distance vision versus the vehicle (placebo) on day 30 at hour 3. Additionally, improvement was seen as early as 15 minutes and lasted through 6 hours. There were no serious adverse events observed in participants receiving VUITY in either the GEMINI 1 or GEMINI 2 study. The most common adverse events occurring at a frequency of >5% were headache and eye redness.
VUITY Eyedrop Details
pilocarpine hydrochloride ophthalmic solution 1.25%
VUITY (pilocarpine hydrochloride ophthalmic solution) 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride. The chemical name for pilocarpine hydrochloride is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]oxolan-2-one hydrochloride. Its molecular weight is 244.72 and its molecular formula is C11H16N2O2 · HCl. Its structural formula is:
Each mL of VUITY contains pilocarpine hydrochloride 1.25% (12.5 mg) as the active ingredient, equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative is: benzalkonium chloride 0.0075%. Inactive ingredients in the ophthalmic solution are: boric acid, sodium citrate dihydrate, sodium chloride, purified water, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary
It is indicated for the treatment of presbyopia in adults.
The recommended dosage of VUITY is one drop in each eye once daily.
VUITY is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients.
Warnings and precaution
1. Poor Illumination
Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm. Patients should be advised not to drive or use machinery if vision is not clear.
2. Risk of Retinal Detachment
Rare cases of retinal detachment have been reported with other miotics when used in susceptible individuals and those with pre-existing retinal disease. Patients should be advised to seek immediate medical care with sudden onset of vision loss.
VUITY is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens.
4. Use with Contact Lenses
Contact lens wearers should be advised to remove their lenses prior to the instillation of VUITY and to wait 10 minutes after dosing before reinserting their contact lenses.
5. Potential for Eye Injury or Contamination
To prevent eye injury or contamination, care should be taken to avoid touching the dispensing bottle to the eye or to any other surface
Distributed by: Allergan, an AbbVie Company
Manufactured for: AbbVie Inc.
North Chicago, IL 60064 USA
Allergan is an affiliate of AbbVie Inc.