LENZ Therapeutics Announces Submission of Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency for VIZZ® for the Treatment of Presbyopia in the United Kingdom
Rhea-AI Summary
LENZ Therapeutics (Nasdaq: LENZ) submitted a Marketing Authorization Application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for VIZZ® (aceclidine 1.44%) to treat presbyopia in adults on April 20, 2026.
This marks the sixth ex-U.S. regulatory submission for VIZZ following FDA approval in July 2025 and EMA validation in March 2026. Three Phase 3 CLARITY trials met all primary and secondary endpoints; VIZZ improved near vision within 30 minutes, lasting up to 10 hours, and showed no serious treatment-related adverse events in over 30,000 treatment days.
Positive
- MHRA MAA submission for VIZZ on April 20, 2026
- Sixth ex-U.S. regulatory submission, supporting global expansion
- Phase 3 success: CLARITY trials met all primary and secondary endpoints
- Rapid onset and duration: improved near vision within 30 minutes, up to 10 hours
- Safety data: no serious treatment-related adverse events in >30,000 treatment days
- U.S. approval in July 2025 supports commercial rollout
Negative
- None.
News Market Reaction – LENZ
In the Apr 20 session, LENZ declined 0.49%, reflecting a mild negative market reaction. Argus tracked a trough of -2.0% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 24 | Earnings and update | Positive | -17.9% | Reported 2025 results, initial VIZZ revenue and EMA submission timing. |
| Mar 17 | Earnings date notice | Neutral | +6.5% | Announced date and access details for Q4 and full-year 2025 call. |
| Mar 10 | EMA MAA submission | Positive | -2.9% | Filed EMA MAA for VIZZ supported by successful Phase 3 CLARITY trials. |
| Feb 23 | Investor conferences | Neutral | +2.6% | Planned management presentations and 1x1 meetings at two March conferences. |
| Jan 14 | Consumer campaign | Positive | +12.0% | Launched “Make it VIZZable” campaign with a celebrity brand ambassador. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Positive commercial and promotional milestones have often seen aligned gains, while earnings and major regulatory updates have previously met with selling pressure.
Over the last few months, LENZ has transitioned from launch to expansion for VIZZ, highlighted by FDA approval in July 2025 and ex‑U.S. growth. A Jan 14 consumer campaign with a high-profile ambassador coincided with an 11.99% gain. The Mar 10 EMA MAA submission and Mar 24 earnings/10‑K update saw declines of 2.93% and 17.91%, despite positive CLARITY data and initial revenue. Today’s MHRA MAA news continues that global regulatory trajectory for VIZZ.
Key Terms
marketing authorization application regulatory
medicines and healthcare products regulatory agency regulatory
presbyopia medical
ophthalmic solution medical
phase 3 medical
randomized, double-masked, controlled medical
endpoints medical
adverse events medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
MHRA submission follows EMA validation of the VIZZ MAA in March 2026
Sixth ex-U.S. regulatory submission for VIZZ underscores accelerating global expansion
SAN DIEGO, April 20, 2026 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) today announced that it has submitted a Marketing Authorization Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for the review and approval of VIZZ® (aceclidine ophthalmic solution)
“As we advance in the early product launch in the United States, we continue to position VIZZ for broad international expansion which now includes a key regulatory advancement for the over 20 million adults in the United Kingdom affected by age-related blurry near vision. Positive early patient and ECP feedback on VIZZ has been resounding that our product provides a highly effective, once-daily alternative to reading glasses,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “On the heels of our recent MAA submission to the European Medicines Agency, our submission to the MHRA is an important step to enable broad commercialization across Europe as we continue to build VIZZ into a global brand.”
The MAA submission is supported by positive data from three randomized, double-masked, controlled Phase 3 studies (CLARITY trials) conducted in the United States, in which VIZZ achieved all primary and secondary endpoints, demonstrating the ability to improve near vision within 30 minutes and last up to 10 hours. VIZZ was well tolerated with no serious treatment-related adverse events observed in over 30,000 treatment days across all three CLARITY trials.
About Presbyopia
Presbyopia is the inevitable loss of near vision associated with aging, impacting the daily lives of nearly all people over the age of 45. As people age, the crystalline lens in their eyes gradually hardens and becomes less able to change shape. This loss of elasticity of the lens reduces the ability of the lens to focus incoming light from near objects onto the retina. Adults over 50 years of age lose, on average, 1.5 lines of near vision every six years. Although the progression of presbyopia is gradual, presbyopes often experience an abrupt change in their daily life as the symptoms become more pronounced starting in their mid-40s, when reading glasses or other corrective aids are suddenly necessary to read text or conduct close-up work. Presbyopia is typically self-diagnosed and self-managed with over-the-counter reading glasses, or managed, after evaluation by an ECP, with prescription reading or bifocal glasses or multifocal contact lenses.
About VIZZ (aceclidine ophthalmic solution)
VIZZ (aceclidine ophthalmic solution)
VIZZ Indication and Important Safety Information
INDICATION
VIZZ (aceclidine ophthalmic solution)
IMPORTANT SAFETY INFORMATION
- Do not use VIZZ if allergic to any of the ingredients.
- To help avoid potential eye injury or contamination of the product, do not allow the vial tip to touch the eye or any surfaces. Discard the opened vial immediately after use.
- Contact lenses should be removed before using VIZZ. After dosing, contact lenses can be reinserted after 10 minutes.
- If using more than one topical eye medication, the medicines should be administered at least 5 minutes apart.
- Temporary dim or dark vision may be experienced after using VIZZ. Do not drive or operate machinery if vision is not clear.
- Seek immediate medical care if sudden onset of flashing lights, floaters, or vision loss is experienced.
ADVERSE REACTIONS
The most common reported adverse reactions of participants were instillation site irritation (
For additional information, please see the full Prescribing Information available at www.VIZZ.com/full-prescribing-information.pdf.
About LENZ Therapeutics
LENZ Therapeutics is a pharmaceutical company focused on the commercialization of VIZZ® (aceclidine ophthalmic solution)
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. You can identify forward-looking statements by words such as “may,” “will,” “could,” “can,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “poised,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, but not all forward-looking statements will contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing and outcome of the MHRA’s review of the Marketing Authorisation Application for VIZZ, the potential commercial availability of VIZZ in the United Kingdom, LENZ’s mission to bring VIZZ to patients around the world, and plans for commercialization through strategic partnerships. These statements are based on numerous assumptions concerning LENZ, VIZZ, target markets and regulatory agencies and involve substantial risks, uncertainties and other factors that could cause actual results to differ materially from those projected, expressed or implied by these forward-looking statements, including risks related to regulatory approvals, market conditions, and those risk factors described in the section titled “Risk Factors” in our Annual Report on Form 10-K filed for the year ended December 31, 2025 and our subsequent filings with the Securities and Exchange Commission. We cannot assure you that the forward-looking statements in this press release or the assumptions upon which they are based will prove to be accurate. The forward-looking statements in this press release are made as of the date of this press release. Except as otherwise required by applicable law, LENZ disclaims any duty to update any forward-looking statements. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Contact:
Dan Chevallard
LENZ Therapeutics
IR@LENZ-Tx.com
