LENZ Therapeutics Announces MFDS Submission of New Drug Application for LNZ100 (VIZZ™) in South Korea for the Treatment of Presbyopia

Rhea-AI Summary

LENZ Therapeutics (NASDAQ: LENZ) said Lotus Pharmaceutical submitted a New Drug Application (NDA) to the South Korea MFDS for VIZZ to treat presbyopia on December 1, 2025.

The filing uses positive Phase 3 CLARITY data: VIZZ met all primary and secondary near-vision endpoints, improved near vision within 30 minutes with effect up to 10 hours, and showed no serious treatment-related adverse events in > 30,000 treatment days. Under a May 2025 license, LENZ is eligible for up to $125 million in milestones plus tiered double-digit royalties; Lotus holds exclusive rights for South Korea and several Southeast Asian countries.

Positive

• Phase 3 success: all primary and secondary near-vision endpoints met
• Onset and duration: near-vision improvement in 30 minutes, lasting up to 10 hours
• Safety: no serious treatment-related adverse events in > 30,000 treatment days
• Commercial terms: LENZ eligible for up to $125 million in milestones

Negative

• Common adverse reactions reported: instillation site irritation, dim vision, headache, eye redness
• Milestone payments are contingent: up to $125 million (not guaranteed)

News Market Reaction

-0.39%

43 alerts

-0.39% News Effect

+2.0% Peak Tracked

-4.3% Trough Tracked

-$3M Valuation Impact

$886M Market Cap

0.7x Rel. Volume

On the day this news was published, LENZ declined 0.39%, reflecting a mild negative market reaction. Argus tracked a peak move of +2.0% during that session. Argus tracked a trough of -4.3% from its starting point during tracking. Our momentum scanner triggered 43 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $886M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 3 trials: 3 studies Onset of effect: 30 minutes Duration of effect: up to 10 hours +2 more

5 metrics

Phase 3 trials 3 studies CLARITY trials supporting MFDS NDA

Onset of effect 30 minutes Time to near-vision improvement in CLARITY trials

Duration of effect up to 10 hours Near-vision benefit duration in CLARITY trials

Treatment exposure over 30,000 treatment days Safety exposure across three CLARITY trials

Milestone potential $125 million Regulatory and commercial milestones under Lotus agreement

Market Reality Check

Price: $12.88 Vol: Volume 850,938 is near th...

normal vol

$12.88 Last Close

Volume Volume 850,938 is near the 20-day average of 870,451 (relative volume 0.98). normal

Technical Price 24.5 is trading below the 200-day MA of 31.21 and 51.39% below the 52-week high.

Peers on Argus

LENZ fell 5.33% while several biotech peers also traded lower (e.g., DNTH -5.24%...

LENZ fell 5.33% while several biotech peers also traded lower (e.g., DNTH -5.24%, ELVN -6.1%, TRVI -5.89%), but momentum data do not flag a coordinated sector move.

Historical Context

5 past events · Latest: Dec 01 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 01	Ex-U.S. NDA filing	Positive	-0.4%	Lotus filed MFDS NDA for VIZZ in South Korea using Phase 3 data.
Nov 25	Investor conferences	Neutral	+2.8%	Management scheduled multiple early December investor conference appearances.
Nov 05	Q3 2025 earnings	Neutral	-23.5%	Reported FDA approval, launch progress, partnerships, cash and net loss for Q3.
Oct 29	Earnings call date	Neutral	-0.6%	Announced date and access details for Q3 2025 results webcast.
Sep 30	U.S. launch update	Positive	+3.8%	Announced U.S. commercial availability of VIZZ for presbyopia via ePharmacy.

Pattern Detected

The stock has shown mixed reactions, with occasional sell-offs on fundamentally positive or neutral updates such as regulatory milestones and earnings.

Recent Company History

Over recent months, LENZ has progressed from FDA approval and U.S. commercial availability of VIZZ to expanding global reach. The company launched VIZZ in the U.S. and reported Q3 2025 results featuring license revenue and partnership milestones, alongside ongoing net losses. Today’s MFDS NDA submission for VIZZ in South Korea builds on these milestones, representing a second Asian regulatory filing under the Lotus partnership and extending the franchise beyond the U.S. market.

Market Pulse Summary

This announcement marks a meaningful step in LENZ’s globalization of VIZZ, with Lotus submitting an ...

Analysis

This announcement marks a meaningful step in LENZ’s globalization of VIZZ, with Lotus submitting an MFDS NDA in South Korea based on three Phase 3 CLARITY trials and over 30,000 treatment days of safety data. The deal structure includes up to $125 million in milestones plus tiered royalties. Investors may track regulatory timelines, future ex-U.S. submissions, and subsequent commercial performance relative to past milestones and financial updates.

Key Terms

new drug application, nda, mfds, phase 3, +4 more

8 terms

new drug application regulatory

"Lotus has submitted a New Drug Application (NDA) to the Ministry..."

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

nda regulatory

"Lotus has submitted a New Drug Application (NDA) to the Ministry..."

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

mfds regulatory

"NDA to the Ministry of Food and Drug Safety (MFDS) for the review..."

South Korea’s Ministry of Food and Drug Safety (MFDS) is the national regulator that reviews and approves medicines, medical devices, food safety and cosmetics. For investors, MFDS decisions act like a gatekeeper — approvals or rejections can make or break a product’s ability to reach markets, directly affecting a company’s future sales, valuation and risk profile.

phase 3 medical

"positive data from three randomized, double-masked, controlled Phase 3 studies..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

double-masked medical

"positive data from three randomized, double-masked, controlled Phase 3 studies..."

Double-masked describes a clinical study setup where neither the people receiving treatments nor the researchers who administer or assess them know who gets the active therapy versus a placebo or comparison. This reduces conscious or unconscious bias and makes results more reliable for regulators and doctors. For investors, double-masked trials carry more credibility—like a taste test where neither the tasters nor the servers know which sample is which—so positive outcomes and approvals are taken more seriously.

presbyopia medical

"for the treatment of presbyopia in adults in South Korea."

Presbyopia is the gradual loss of the eye’s ability to focus on close objects as the lens stiffens with age, causing tasks like reading or using a phone to require holding things farther away or using glasses. It matters to investors because it drives steady demand for corrective products and treatments—such as reading glasses, contact lenses, surgical procedures and emerging drugs—much like an aging population consistently needs new or replacement consumer goods and services.

adverse events medical

"no serious treatment-related adverse events observed in over 30,000 treatment days..."

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

royalties financial

"tiered, double-digit royalties on future net sales."

Payments made to the owner of an asset or intellectual property each time that asset is used or a product is sold, often calculated as a percentage of sales or a set amount per unit. Royalties matter to investors because they create predictable, ongoing income streams and affect a company’s cash flow and valuation—like a landlord collecting rent or an author getting a steady cut whenever a book is sold.

AI-generated analysis. Not financial advice.

Submission of NDA in South Korea by Lotus Pharmaceutical results in the second ex-U.S. regulatory submission for VIZZ

SAN DIEGO and TAIPEI, Taiwan, Dec. 01, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) and Lotus Pharmaceutical Co., Ltd. (“Lotus”, TWSW Stock Code: 1795) today announced that Lotus has submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for the review and approval of VIZZ^TM, for the treatment of presbyopia in adults in South Korea. This represents the first submission for approval under the exclusive license and commercialization agreement signed in May 2025 for South Korea and certain countries in Southeast Asia.

The NDA submission was 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 near vision improvement 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. The most common reported adverse reactions of participants were instillation site irritation, dim vision, headache, and eye redness.  The majority of adverse reactions were mild, transient and self-resolving.

Under the terms of the licensing and commercialization agreement, LENZ is eligible to receive up to $125 million in regulatory and commercial milestone payments, as well as tiered, double-digit royalties on future net sales. In addition to South Korea, Lotus has exclusive development, manufacturing, registration and commercialization rights for VIZZ for the treatment of presbyopia in certain countries in Southeast Asia, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia and Singapore. 

Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical, commented: “We are proud to have completed the MFDS submission for VIZZ in South Korea, a key milestone that reflects the strength of our partnership with LENZ. South Korea is one of the core markets for Lotus, and this filing supports our strategy to expand our current portfolio by leveraging our established commercial footprint and field force. With these capabilities already in place, we can enable an efficient launch that opens new growth avenues with minimal incremental investment. Most importantly, VIZZ has the potential to be a truly life-changing option for millions of South Koreans living with presbyopia, and we are committed to working closely with regulators to bring it to patients as quickly as possible.”

“LENZ is committed to collaborating with trusted partners like Lotus Pharmaceutical to expand global access to VIZZ,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “Lotus’ completion of the MFDS filing marks the second submission for VIZZ in Asia, an important step in bringing this therapy to patients worldwide. We’re excited to reach this achievement together and look forward to supporting Lotus as they advance toward commercial availability in South Korea across Southeast Asia.”

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) 1.44%

VIZZ (aceclidine ophthalmic solution) 1.44% is a once-daily eye drop developed to restore clear near vision for up to 10 hours. Aceclidine is the sole active ingredient in VIZZ and provides rapid and durable near vision improvement. VIZZ is preservative-free and provided in single-dose vials. VIZZ is a predominantly 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. For more information, please visit www.VIZZ.com.

VIZZ Indication and Important Safety Information

INDICATION

VIZZ (aceclidine ophthalmic solution) 1.44% is a prescription eye drop used to treat age-related blurry near vision (presbyopia) in adults.

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 (20%), dim vision (16%), and headache (13%). Adverse reactions reported in >5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving.

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^TM (aceclidine ophthalmic solution) 1.44%, the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. LENZ is commercializing VIZZ in the United States and continues to establish licensing partnerships internationally to provide access to VIZZ globally. LENZ is headquartered in San Diego, California. For more information, visit www.VIZZ.com and www.LENZ-tx.com.

About Lotus

Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with a global presence, focused on commercializing both novel and generic pharmaceuticals to provide patients with better, safer, and more accessible medicines. The company boasts a best-in-class R&D and manufacturing platform in Asia, certified by leading regulatory authorities around the world, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Lotus has established partnerships in nearly every major global market, including the U.S., Europe, Japan, China, and Brazil. The company is currently developing and registering over 100 strategically selected pharmaceutical projects across Asia and the U.S., with more than 250 commercial products. Lotus invests in a diversified portfolio, consisting of high-barrier oncology, complex generics, 505(b)2, NCEs, and biosimilars, through both internal R&D investments and licensing-in partnerships to strengthen its portfolio competitiveness.

Contact:
Dan Chevallard   LENZ Therapeutics IR@LENZ-Tx.com	Jeffrey Tsang, Head of IR & Corp Comms Lotus Pharmaceutical Co., Ltd. investor@lotuspharm.com

               
                
              

FAQ

What did LENZ (NASDAQ: LENZ) announce on December 1, 2025 about VIZZ in South Korea?

Lotus submitted an NDA to the MFDS for VIZZ to treat presbyopia, marking a key regional filing.

What Phase 3 evidence supports the VIZZ NDA submitted to South Korea MFDS?

Three CLARITY Phase 3 trials met all primary and secondary near-vision endpoints with supportive safety data.

How quickly does VIZZ improve near vision according to the CLARITY trials?

VIZZ improved near vision within 30 minutes and effects lasted up to 10 hours in trials.

What safety issues were reported in VIZZ Phase 3 trials referenced in the MFDS submission?

No serious treatment-related adverse events; common reactions included irritation, dim vision, headache, and eye redness.

What commercial and financial terms does LENZ stand to receive under the Lotus agreement?

LENZ is eligible for up to $125 million in regulatory and commercial milestone payments plus tiered double-digit royalties.

Which countries does Lotus hold exclusive rights to develop and commercialize VIZZ?

Lotus holds exclusive rights for South Korea and specified Southeast Asian countries including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore.

Is the South Korea NDA the first ex-U.S. submission for VIZZ?

No; the filing is described as the second ex-U.S. regulatory submission for VIZZ in Asia.