Yuvezzi

Yuvezzi (carbachol and brimonidine tartrate) is a prescription eye drop used once daily to improve near vision in presbyopia, a condition that makes it difficult to focus on close-up objects due to aging.

Yuvezzi improves near vision and depth of focus by making pupils smaller, creating a “pinhole effect” so objects look sharper, especially at close range.

The usual dose of Yuvezzi is one drop in each eye once a day. It starts working within 30 minutes and may last up to 10 hours.

Yuvezzi improved near vision by three lines or more over 8 hours without using glasses or contact lenses, in the clinical trial Phase 3 BRIO I. Near vision improved without the loss of one line or more distance visual acuity.

Blurred or Dark Vision. This medicine can make your vision blurry or make it harder to focus. In low light you may also notice your vision is dim or darker. Do not drive or use machinery if your vision is not clear. Be extra careful when driving at night or doing activities in poor lighting.

Risk of Retinal Problems. This type of medicine has been linked to rare cases of retinal tears or retinal detachment (a serious eye condition). People who already have retinal problems may be at higher risk. Get medical help right away if you suddenly see flashes of light, new floaters (spots or strings in your vision), or experience vision loss.

Eye Inflammation (iritis). Yuvezzi is not recommended to be used when iritis is present.

Blood Flow - Related Conditions. This medicine may worsen conditions related to poor blood circulation. Use it with caution if you have a history of depression, heart or brain circulation problems, Raynaud’s phenomenon, dizziness when standing up, or the blood vessel disease thromboangiitis obliterans. Talk to your doctor if any of these apply to you.

Preventing Eye Injury or Infection. To avoid eye injury or contamination, do not let the tip of the single-dose vial touch your eye, eyelids, or any other surface.

Hypersensitivity. You should not use this medicine if you are allergic to the active ingredients, carbachol or brimonidine tartrate, or any of the inactive ingredients.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

This eye drop may cause serious side effects. Call your doctor at once if you have:

• flashes of light or "floaters" in your vision; or
• severe vision problems, including vision loss.

Common side effects of Yuvezzi may include:

• pain or irritation after using the eye drops;
• blurred vision or trouble seeing clearly; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Yuvezzi dose: one drop in each eye once daily
• Remove contact lenses before instilling Yuvezzi eye drops. Wait 10 minutes after dosing before reinserting contact lenses.
• If more than one eye drop or eye ointment is being used, the medicines must be administered at least 5 minutes apart.
• One single-dose vial can be used to dose both eyes.
• Discard the open single-dose vial and any remaining contents immediately after use.

Yuvezzi is a dual-agent eye drop containing both carbachol and brimonidine tartrate that work together to constrict the pupil (miosis) to extend depth of focus, and engage the ciliary muscle to support accommodation and regulate pupil size.

Carbachol makes the pupil smallerCarbachol is a cholinergic agent that constricts the pupil, creating a “pinhole effect,” which lets only the most direct and focused light into the eye. This results in close-up objects appearing clearer.

Brimonidine helps the effect last and work betterBrimonidine is an alpha-adrenergic agonist that keeps the pupil from widening again by relaxing opposing muscles in the iris and reducing unnecessary muscle activity. This allows the pupil-constricting effect of carbachol to last longer and remain more controlled, thereby maintaining pupil size to support clear near vision throughout the day.

Blood pressure and heart medicines

Yuvezzi contains an ingredient that can lower blood pressure. If you take medicines for high blood pressure or certain heart medications, using them together with Yuvezzi may increase the chance of low blood pressure. Your doctor may want to monitor you more closely.

Medicines that cause drowsiness (CNS Depressants)

Yuvezzi may increase the effects of medicines that make you sleepy. This includes alcohol, opiates, barbiturates, sedatives, or anesthetics. Using these together may cause increased drowsiness or dizziness. This should be considered when combining these products.

Tricyclic antidepressants

Some antidepressants (called tricyclic antidepressants) may change how Yuvezzi works in the body. This could affect how well the medicine works in the eye. Tell your doctor if you are taking antidepressants so they can decide if Yuvezzi is right for you.

MAO Inhibitors

Another type of antidepressant, called MAO inhibitors, may increase the risk of side effects from Yuvezzi, such as low blood pressure. Let your doctor know if you are taking or have recently taken an MAO inhibitor.

• Store at 36°F to 77°F (2°C to 25°C).
• Once a pouch is opened, store the single-dose vials in the foil pouch away from light until ready for use.
• Discard opened single-dose vials and any remaining contents immediately after use.

Active ingredients: carbachol 2.75% and brimonidine tartrate 0.1%

Inactive ingredients: hydroxypropyl methylcellulose (HPMC), sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, water for injection, and may also include hydrochloric acid and/or sodium hydroxide to adjust pH, if necessary.

Manufacturer: Visus Therapeutics, Inc., an affiliate of Tenpoint Therapeutics, Ltd., Seattle, Washington, 98109, USA.