In 2025, the U.S. Food and Drug Administration (FDA) approved VIZZ (aceclidine ophthalmic solution 1.44%) for the treatment of presbyopia in adults. Presbyopia, an age-related condition characterized by reduced near vision, affects millions of individuals over the age of 40.

VIZZ represents a novel pharmacologic approach to manage this condition without the need for reading glasses or invasive procedures.

VIZZ FDA Approval: 31st July, 2025

Indications of VIZZ:

VIZZ is indicated for the treatment of presbyopia in adults.

Dosage and Administration

• Recommended Dose: Instill one drop in each eye, wait 2 minutes, then instill a second drop in each eye once daily from the same single-dose vial.

• Contact Lenses: Remove before instillation; lenses may be reinserted 10 minutes after dosing.

• Multiple Ophthalmic Products: If using more than one, separate administrations by at least 5 minutes.

• Storage: Discard the vial after single use to prevent contamination.

Dosage Form and Strength

• Formulation: Ophthalmic solution

• Strength: Aceclidine 1.44% (supplied in single-dose vials)

• Appearance: Clear to opalescent, colorless to slightly yellow solution

Warnings and Precautions

VIZZ, like other miotic agents, carries specific safety concerns:

1. Blurred Vision

   • Temporary dim or dark vision may occur.

   • Caution advised when driving, especially at night.

2. Risk of Retinal Tear/Detachment

   • Rare cases reported with miotics.

   • Baseline retinal examination recommended before therapy.

   • Urgent evaluation required if flashing lights, floaters, or sudden vision loss occur.

3. Iritis

   • May exacerbate ocular inflammation in patients with prior history.

4. Hypersensitivity

   • Avoid use in patients with known allergy to aceclidine or formulation components.

5. Contact Lens Use

   • Remove lenses before dosing; wait 10 minutes before reinsertion.

6. Risk of Contamination or Injury

   • Avoid touching vial tip to eye or other surfaces.

Side Effects of VIZZ:

VIZZ was studied in over 600 participants with presbyopia across multiple phase 3 trials.

Most Common Adverse Events:

• Instillation site irritation – 20%

• Dim vision – 16%

• Headache – 13%

Other Reactions (>5%):

• Conjunctival hyperemia – 8%

• Ocular hyperemia – 7%

Most side effects were mild, transient, and self-resolving.

Table: Key Clinical Information on VIZZ

Use in Special Populations

• Pregnancy: No adequate human studies; animal studies showed no fetal harm.

• Pediatric: Not applicable (presbyopia does not occur in children).

• Geriatric: No differences in safety or effectiveness compared to younger adults.

Mechanism of Action of VIZZ:

Aceclidine is a cholinergic muscarinic agonist. VIZZ acts primarily as a pupil-selective miotic, stimulating iris sphincter contraction.

This produces a pinhole effect, increasing depth of focus and thereby improving near vision with minimal ciliary muscle involvement.

VIZZ Overdose:

• Topical use: Rare systemic toxicity.

• Symptoms (if absorbed or ingested): Sweating, salivation, nausea, tremors, bradycardia, hypotension.

• Management: Supportive care; IV fluids may help recovery.

Conclusion

VIZZ (aceclidine ophthalmic solution 1.44%) provides a new non-invasive option for adults with presbyopia, offering improved near vision through a pupil-selective miotic mechanism.

While generally well-tolerated, patients should be counseled regarding transient dim vision, potential risks such as retinal detachment, and proper administration techniques to maximize safety and efficacy.

Glasses for Presbyopia