On Wednesday, the U.S. Food and Drug Administration (FDA) approved Tenpoint Therapeutics Ltd.’s Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, the first and only dual-agent eye drop for presbyopia in adults.Presbyopia, the gradual loss of near vision that typically begins around age 45, affects about two billion people globally and 128 million people in the U.S.Yuvezzi is expected to be broadly commercially available in the U.S. in the second q ...

Struggling to see up close? VIZZ is a revolutionary, once-daily eye drop and alternative to reading glasses to restore near vision for up to 10 hours The “Make it VIZZable” campaign features SJP enjoying the everyday convenience of clear near vision provided by using the VIZZ eye drops. VIZZ is available nationwide by prescription through eye doctors; visit VIZZ.com to learn more and to find a local provider offering a free sample SAN DIEGO, Jan. 14, 2026 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq ...

Core Viewpoint - LENZ Therapeutics has entered into an exclusive distribution agreement with Lunatus to register and commercialize VIZZ for the treatment of presbyopia in the Middle East region, marking a significant expansion of its commercial partnerships outside the United States [1] Group 1: Agreement Details - The agreement allows Lunatus to retain exclusive commercialization rights for VIZZ in several Middle Eastern countries, including the United Arab Emirates, Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, Jordan, Lebanon, and Iraq [1] - LENZ Therapeutics will receive upfront, regulatory, and commercial milestone payments, along with a significant share of revenue generated in the region through a pre-determined minimum product supply price [1] Group 2: Product Information - VIZZ is the first and only FDA-approved aceclidine-based eye drop specifically for the treatment of presbyopia, highlighting its unique position in the market [1] - The commercial launch of VIZZ in the United States is gaining momentum, which supports the strategic expansion into international markets [1] Group 3: Company Strategy - The partnership with Lunatus represents LENZ's fourth commercialization partnership for VIZZ, demonstrating the company's commitment to expanding global access to this presbyopia therapy [1]

Core Insights - LENZ Therapeutics has entered into an exclusive distribution agreement with Lunatus Marketing & Consulting for the commercialization of VIZZ in the Middle East, which includes revenue sharing and milestone payments [1][2][3] Company Overview - LENZ Therapeutics is focused on the commercialization of VIZZ (aceclidine ophthalmic solution) 1.44%, the first FDA-approved eye drop for presbyopia, impacting approximately 1.8 billion people globally and 128 million in the U.S. [9] - Lunatus is a Dubai-based pharmaceutical company specializing in the commercialization of healthcare products in the Middle East, established in 2003 [10] Product Information - VIZZ is a once-daily eye drop designed to restore clear near vision for up to 10 hours, utilizing aceclidine as the active ingredient [5] - The product is preservative-free and provided in single-dose vials, offering a pupil-selective miotic effect to improve vision [5] Market Context - The partnership with Lunatus represents LENZ's fourth commercialization partnership for VIZZ, aimed at expanding access to presbyopia treatment in key strategic regions [3] - Presbyopia affects nearly all individuals over the age of 45, with adults over 50 losing an average of 1.5 lines of near vision every six years [4]

Financial Data and Key Metrics Changes - The company launched its product in early October after receiving approval in late July, and within the first four weeks, it recorded 5,000 scripts written by 2,500 doctors, indicating strong initial interest and confidence in the product [27][29]. - Awareness of the product among doctors exceeded 90%, which is considered exceptional for a new product [12]. Business Line Data and Key Metrics Changes - The company has fully operational e-pharmacy and retail pharmacy channels, allowing consumers to order the product online or pick it up at local pharmacies [10][9]. - The company is focusing on getting samples into the hands of doctors to build confidence and awareness, with 70,000 samples distributed across approximately 7,000 offices [51]. Market Data and Key Metrics Changes - The product is seeing a demographic skew towards females, with 60% of orders coming from women, primarily in the 45-55 age group [18][66]. - The company is targeting urban areas for its product launch, aligning with its initial market segmentation strategy [66]. Company Strategy and Development Direction - The company plans to turn on direct-to-consumer (DTC) marketing in Q1, which is expected to drive new patient starts and increase product awareness [76]. - The company is focused on establishing its product as a cornerstone of a larger portfolio, with plans for business development and mergers and acquisitions post-2026 [41]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's performance based on positive feedback from doctors and patients, noting that the product works effectively for nearly all patients [3][5]. - The company is aware of the competitive landscape, particularly regarding other products like Vuity, and believes its product offers superior efficacy and duration of effect [44][45]. Other Important Information - The company has partnerships in place for international markets, including South Korea and Greater China, and is pursuing registration in Europe [36][37]. - The supply chain is robust, with the product being manufactured in the U.S. and imported duty-free, ensuring cost-effectiveness [38]. Q&A Session Summary Question: How is the early launch going? - The company reported strong initial metrics with 5,000 scripts written and 2,500 doctors participating within the first four weeks, indicating significant interest [27][29]. Question: What is the strategy for DTC marketing? - The company plans to launch DTC marketing in Q1, focusing on digital platforms and utilizing a celebrity spokesperson to enhance brand awareness [76][18]. Question: How does the company view its competition? - Management highlighted that their product is the only pupil-selective miotic and believes it has a significant advantage over competitors like Vuity, which has shown limited efficacy [42][44]. Question: What are the plans for international expansion? - The company has submitted an NDA in South Korea and has partnerships in place for Greater China and Canada, with plans to explore further international opportunities [36][37]. Question: How is the product being received in the market? - Feedback from doctors and patients has been overwhelmingly positive, with reports of effective near vision improvement and minimal side effects [3][5].

Summary of LENZ Therapeutics FY Conference Call Company Overview - **Company**: LENZ Therapeutics (NasdaqGS:LENZ) - **Product**: Viz, a presbyopia eye drop approved by the FDA in July 2025 and launched in October 2025 Key Points Product Launch and Market Performance - The launch of Viz has exceeded internal expectations with a 90% brand awareness achieved within two months of launch [3][4] - Over 7,000 offices received product samples, leading to over 2,500 doctors writing prescriptions and 5,000 filled prescriptions in the first four weeks [4][4] - The product is reported to work effectively for nearly all users, restoring near vision within 10-15 minutes and lasting throughout the workday [5][6] Efficacy and Safety - The product has shown a positive safety profile with minimal adverse effects reported, such as mild headaches and transient stinging upon application [9][10] - Anecdotal evidence suggests that Viz may also improve distance vision for some users, although this is not a labeled claim [6][14] - The product's comfort profile is favorable, with users adapting quickly to any initial dimness experienced [13][14] Direct-to-Consumer (DTC) Strategy - DTC advertising is set to begin in Q1 2026, targeting presbyopes, particularly those who have worn contact lenses or had LASIK surgery [16][19] - Sarah Jessica Parker has been announced as the brand spokesperson, supported by local influencers and digital advertising [17][23] - The DTC campaign aims to drive consumer awareness and increase prescriptions through eye care professionals [16][20] Pricing and Market Potential - Viz is priced at approximately $79 for a one-month supply, with a discount for three-month purchases [28][30] - The company anticipates a significant market opportunity, estimating a $3 billion market with 6% penetration translating to 8 million users [44] - The product is expected to appeal to a large demographic, including active aging individuals and those seeking convenience over traditional reading glasses [42][19] Competitive Landscape - Competitors Brimochol and Phentolamine are expected to enter the market in 2026, but LENZ believes Viz has a superior efficacy profile [49][50] - Viz maintains a significant advantage with a higher percentage of users achieving the desired pupil size for effective near vision improvement compared to competitors [50][51] Future Outlook - The company is focused on building a strong foundation with healthcare professionals before ramping up consumer advertising [16][45] - Initial feedback indicates a strong likelihood of daily use among patients, although conservative estimates suggest an average of three days per week for refill assumptions [43][44] - The company plans to monitor new patient starts and refill rates as key performance indicators in the coming quarters [44][48] Additional Insights - The product's adoption is primarily driven by enthusiastic doctors introducing it to patients during regular eye exams, with minimal consumer advertising currently in place [21][20] - The demographic data from e-pharmacy scripts indicates a slight female skew and a higher usage rate among individuals aged 45-65 [36][41]

Core Insights - Lotus Pharmaceutical has submitted a New Drug Application (NDA) for VIZZ in South Korea, marking the second regulatory submission for the drug outside the U.S. [1] - The NDA submission is backed by positive results from three Phase 3 studies in the U.S., demonstrating VIZZ's effectiveness in improving near vision [2] - Under the licensing agreement, LENZ Therapeutics stands to receive up to $125 million in milestone payments and royalties from future sales of VIZZ [3] Company Overview - LENZ Therapeutics is focused on the commercialization of VIZZ, the first FDA-approved aceclidine-based eye drop for presbyopia, which affects approximately 1.8 billion people globally [10] - Lotus Pharmaceutical, founded in 1966, is an international pharmaceutical company with a strong R&D and manufacturing platform, certified by major regulatory authorities [11] Product Information - VIZZ (aceclidine ophthalmic solution) 1.44% is designed to restore clear near vision for up to 10 hours and is preservative-free [6] - The drug is indicated for the treatment of age-related blurry near vision (presbyopia) in adults [7] Market Context - Presbyopia affects nearly all individuals over the age of 45, with significant implications for daily activities and quality of life [5] - The NDA submission in South Korea is part of a broader strategy to expand VIZZ's market presence in Southeast Asia, including countries like Thailand, Vietnam, and Malaysia [3]

Core Insights - LENZ Therapeutics is focused on the commercialization of VIZZ™ (aceclidine ophthalmologic solution) 1.44%, the first and only FDA-approved eye drop for treating presbyopia in adults [1][3] - The company will host a webcast on November 5, 2025, to report its third quarter 2025 financial results and recent corporate highlights [1] Company Overview - LENZ Therapeutics is headquartered in San Diego, California, and is dedicated to providing access to VIZZ globally through licensing partnerships [3] - Presbyopia affects an estimated 1.8 billion people worldwide, including 128 million in the United States [3]

Core Viewpoint - LENZ Therapeutics has launched VIZZ, the first FDA-approved aceclidine-based eye drop for treating presbyopia, which affects approximately 128 million adults in the U.S. The product is expected to be commercially available by mid-Q4 2025 [1][7]. Product Overview - VIZZ (aceclidine ophthalmic solution) 1.44% is designed to improve near vision for up to 10 hours and is administered as a once-daily eye drop [3][4]. - The mechanism of action involves a predominantly pupil-selective miotic effect, contracting the iris sphincter muscle to create a pinhole effect that enhances depth of focus without causing a myopic shift [1][4]. Clinical Efficacy - In the CLARITY Phase 3 clinical trial, 93% of participants achieved 20/40 or better near vision within 30 minutes of application, with effects lasting up to 10 hours [1][4]. Market Potential - Presbyopia is a common age-related condition impacting nearly all individuals over 45, with adults over 50 losing an average of 1.5 lines of near vision every six years [2][5]. - The global market for presbyopia treatments is significant, with an estimated 1.8 billion people affected worldwide [7]. Company Strategy - LENZ Therapeutics is focused on commercializing VIZZ in the U.S. and establishing international licensing partnerships to expand global access [7].

Core Insights - LENZ Therapeutics has launched VIZZ, the first FDA-approved aceclidine-based eye drop for presbyopia, which is expected to improve near vision for up to 10 hours in adults [1][2][10] - VIZZ is set to be commercially available to consumers starting in October 2025, with broader availability anticipated by mid-Q4 2025 [1][10] - Presbyopia affects approximately 128 million adults in the United States, highlighting a significant market opportunity for VIZZ [1][10] Product Details - VIZZ (aceclidine ophthalmic solution) 1.44% is designed to restore clear near vision for up to 10 hours and is preservative-free, provided in single-dose vials [5][10] - The mechanism of action involves a predominantly pupil-selective miotic effect, contracting the iris sphincter muscle to create a pinhole effect that enhances depth of focus without causing a myopic shift [2][5] - In the CLARITY Phase 3 clinical trial, 93% of participants achieved 20/40 or better near vision within 30 minutes of application [2] Market Context - Presbyopia is a common age-related condition that affects nearly all individuals over the age of 45, with adults over 50 losing an average of 1.5 lines of near vision every six years [4][10] - The condition is typically self-managed with over-the-counter reading glasses, but VIZZ offers a new prescription option for improved near vision [4][10] - The global market for presbyopia treatments is substantial, with an estimated 1.8 billion people affected worldwide [10]