Many patients and staff members are excited about VUITY (pilocarpine hydrochloride ophthalmic solution) is provided as a 1.25% solution (12.5 mg/mL).
They can finally see without glasses for reading. Our hyperopic (short eye) patients are particularly excited as they need glasses for distance, intermediate, and reading.
Viuty works. The 2 key concerns I have are:
1. The rare risk of retinal hole or detachment with its key ingredient Pilocarpine.
In medical school and residency, we tried to not give pilocarpine for glaucoma (a blinding disease) because of the rare risk of retinal detachment, especially in patients who were myopic (a long eyeball), had retinal disease, or had previous cataract surgery (ie, pseudophakic). The risk is rare it is said, but I could not find a long-term randomized, prospective double-blind trial published in the literature. The study done by the company for the FDA approval was over 30 days below: that may not be enough time to assess for the real risk of retinal pathology. Thus it is possible the risk of pilocarpine and retinal pathology was under-reported: Afterall how can you prove Pilocarpine was the cause?
2. The preservative: 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.
Benzalkonium chloride (BAK) is well known to cause allergy, burning, itching, and, if used for years, damage to the delicate meibomian gland cells and mucin cells. Thus any products with BAK is best used as little as possible, though most glaucoma medications have BAK. Since glaucoma is a potentially blinding disease, we take the risks of using BAK-containning drops over the risk of not treating high eye pressure which can cause glaucoma.
https://www.drugs.com/pro/vuity-eye-drops.html
4 CONTRAINDICATIONS
VUITY is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients.
5 WARNINGS AND PRECAUTIONS
5.1 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.
5.2 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.
5.3 Iritis
VUITY is not recommended to be used when iritis is present because adhesions (synechiae) may form between the iris and the lens.
5.4 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.
5.5 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.
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in labeling:
- Hypersensitivity [see Contraindications (4)]
6.1 Clinical Trials Experience
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.
VUITY was evaluated in 375 patients with presbyopia in two randomized, double-masked, vehicle-controlled studies (GEMINI 1 and GEMINI 2) of 30 days duration. The most common adverse reactions reported in >5% of patients were headache and conjunctival hyperemia. Ocular adverse reactions reported in 1-5% of patients were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation.
From our Team:
Viuty
eyedrops for Presbyopia
IS A CASH ONLY product
and insurances WILL NOT PAY FOR IT !!
I am reminding
everyone because I am seeing some Prior Authorizations being sent by the
pharmacies which should not be the case since this medication is ONLY
CASH paid by patient.
Doctors/Scribes: please remind the patients that
insurance will not pay it therefore they should not be using their insurance
card.
Also-- reminder
that when a patient uses it and they do not think it is effective enough or
they have a headache, tell them to use them for 7 consecutive days (this way they will
get the full efficacious effect, and any adverse effect should have
dissipated.)
Techs: If you get Prior Authorizations, please call the patients and
let them know they it won’t be covered. NO NEED TO DO A PA
Normally this
eyedrop costs around $86 per bottle ( Ijust looked it up in the GoodRx website)
References: A literature search on Pubmed of Pilocarpine and retinal detachment Jan 24, 2022
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