FDA approves LENZ Therapeutics' VIZZ for presbyopia

LENZ Therapeutics, Inc., has received FDA approval for VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults.

This news follows just over 9 months since the company submitted its new drug application (NDA)—and announced one week ahead of the federal agency’s assigned Prescription Drug User Fee Act (PDUFA) target action date of Aug. 8.

Exciting stuff! Tell me about this drop.

Originally dubbed LNZ100 while under clinical investigation, Vizz (pronounced similar to Fizz) is a preservative-free, single-use, once-daily eye drop formulated with a unique (and key) active ingredient: aceclidine.

More specifically: Aceclidine 1.44%

What this is: A small-molecule muscarinic acetylcholine receptor agonist that can cause miosis—potentially resulting in a “pinhole” effect to improve near vision and prevent a myopic shift.
- Check out its long-standing clinical history across the globe

Wait—wasn’t Lenz investigating two drops?

That’s right—LNZ100 and LNZ101.

LNZ100 (1.75% aceclidine)
LNZ101 (1.75% aceclidine and brimonidine)

As you’ll have noticed, though, the final version is 1.44% aceclidine.

Hold up … why the change in concentration?

Excellent question. We asked LENZ the very same.

Their answer: President and CEO Eef Schimmelpennink shared that this change in concentration strength is “purely driven by how the FDA wants to talk about the product: aceclidine-HCl (hydrochloride) is 1.75%, defined as aceclidine in solution (like the label states) makes it aceclidine 1.44%.
- He emphasized: “It is the same product.”

Got it. So what’s the recommended dosing?

Per Vizz’s newly-released prescribing information (PI): One drop of the prescription-based solution in each eye should be topically administered before waiting 2 minutes until a second drop in each eye. The daily frequency of this: Just once.

And its target patient base?

Adult patients diagnosed with presbyopia.

And keep in mind: VIZZ also works for those who previously underwent laser-assisted in situ keratomileusis (LASIK) or cataract surgery (though patients should consult with their eyecare provider to verify the drop is right for them).

Now give me a quick review of the supporting data for this approval.

Three randomized, double-masked, controlled phase 3 studies were included in its NDA submission.

CLARITY 1 (NCT05656027)
- 466 participants, 42 days
  - Primary endpoint: Participants who achieved a 3-line or greater improvement from baseline in the study eye with no loss in best-corrected distance visual acuity (BCDVA) at 5 letters or more of distance vision (at 4 months)
CLARITY 2 (NCT05728944)
- 466 participants, 42 days
  - Primary endpoint: Participants who achieved a 3-line or greater improvement from baseline in the study eye (compared to vehicle)
CLARITY 3 (NCT05753189)
- 217 participants, 6 months
  - Primary endpoint: Participants who experienced adverse events (AEs) and monocular BCDVA changes at 4 months

And all three studies met their primary endpoints?

That’s correct—VIZZ (the then-LNZ100) achieved all primary and secondary endpoints, and CLARITY 3 showed long-term safety with no serious treatment-related AEs observed in any of the studies.

A highlights look at VIZZ’s performance in the first two CLARITY studies’ findings:

71% of patients achieved a ≥ 3-line improvement at 30 minutes
71% achieved a ≥ 3-line improvement at 3 hours
40% achieved ≥ 3-line improvement at 10 hours

Read our full coverage here.

Glad to hear no major AEs. But were any reported at all?

The most common:

Instillation site irritation (20%)
Dim vision (16%)
Headache (13%)

As for adverse reactions, these included conjunctiva hyperemia (8%) and ocular hyperemia (7%)—both of which were reported in >5% of study participants.

Take note: The majority of reported adverse reactions were “mild, transient, and self-resolving.”

And what warnings/precautions should be kept in mind when using these drops?

The product’s PI listed the following:

Blurred vision
Risk for retinal tear / detachment
Iritis
Hypersensitivity

Duly noted. So what’s next?

Samples should be available in the U.S. as early as October 2025, stated the company, with full availability by mid-Q4.

Translation: Sometime between Oct. 31 and Dec. 31, 2025.

“We are ready and excited to launch the first and only once-daily eye drop with proven efficacy for up to 10 hours into the market,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics.

And finally, what’s the big-picture significance of this approval?

LENZ just made global history in becoming the first to receive approval of an acelcidine-based eye drop for a presbyopia indication

For more information about VIZZ and full prescribing information, head over to its product website.

And speaking of the global front: Check out this recent news on LENZ’s plans for VIZZ’s Canadian approval.