FDA

FDA greenlights aceclidine eye drop for presbyopia

August 5, 2025

Brand name: Vizz

Generic name: aceclidine

Manufacturer: LENZ Therapeutics

Approval date: July 31, 2025

FDA approved Vizz (aceclidine ophthalmic solution) 1.44%, a cholinergic agonist, for the treatment of presbyopia in adults.

According to the Prescribing Information, aceclidine is a predominately pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. Vizz causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision.

Efficacy

Approval was based on results from two randomized, double-masked, controlled phase 3 studies. CLARITY 1 (NCT05656027) and CLARITY 2 (NCT06045299) evaluated safety and efficacy of Vizz in 466 participants dosed once daily for 42 days. Participants were aged 45 to 75 years with a refractive range from -4.00 to +1.00 D sphere, astigmatism up to 2.00 D, and a spherical equivalent no more myopic than -4.00 D. Post-refractive surgery and/or pseudophakic patients were also included in both studies. Participants were instructed to instill two drops of Vizz (or control) in each eye once daily, one drop in each eye followed by a second drop in each eye two minutes later. Ophthalmic efficacy assessments were conducted on day 1, day 15, and day 28 of the study at various timepoints through 10 hours post dose.

Study participants were randomly assigned to receive aceclidine or brimonidine in CLARITY-1, and aceclidine or vehicle control in CLARITY-2. Primary endpoint was the proportion of participants gaining ≥3 lines in distance corrected, near visual acuity at 40cm, without loss of 1 line or more (≥5 letters) of distance corrected, distance visual acuity at 4 meters, measured 3 hours after administration on day 1.

In CLARITY-1, 65% of aceclidine recipients met the primary endpoint vs. 12% of brimonidine recipients (P <.01). In CLARITY-2, 71% of the aceclidine group achieved the primary endpoint vs. 8% of the vehicle group (P <.01). In both trials, aceclidine was able to improve near vision within 30 minutes, lasting up to 10 hours post dose.

Vizz dosed once daily was also evaluated for long term safety in 217 participants with presbyopia in a separate randomized, double-masked, controlled phase 3 study (CLARITY-3; NCT05753189) for a 6-month duration.

Safety

The most common adverse reactions reported in the trials were instillation site irritation (20%), dim vision (16%), and headache (13%).

Sources:

Vizz (aceclidine) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218585s000lbl.pdf Revised July 2025. Accessed August 4, 2025.

Lenz Therapeutics announces US FDA approval of Vizz™ for the treatment of presbyopia. [News release]. 2025. https://ir.lenz-tx.com/news-events/press-releases/detail/39/lenz-therapeutics-announces-us-fda-approval-of-vizz-for-the-treatment-of-presbyopia