Core Insights - LENZ Therapeutics, Inc. has received FDA approval for VIZZ (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia, marking it as the first and only aceclidine-based eye drop approved for this condition [1][5][17] - The commercial launch of VIZZ began in October 2025, with broad availability expected by mid-Q4 2025 [1][5] - The company has partnered with Sarah Jessica Parker for a direct-to-consumer campaign, set to launch in Q1 2026 [1][2][5] Commercial Highlights - Over 2,500 Eye Care Professionals (ECPs) have prescribed VIZZ, with 40% of them prescribing multiple times, leading to over 5,000 prescriptions filled by October 2025 [1][2][5] - Awareness of VIZZ among ECPs reached 90% in October 2025, supported by extensive marketing efforts including 17,000 unique ECPs detailed and over 5 million digital campaign impressions [5] - The company has provided nearly 70,000 product samples to approximately 7,000 ECP offices, contributing to increased confidence in prescribing VIZZ [5] Financial Overview - As of September 30, 2025, the company reported pro forma cash, cash equivalents, and marketable securities of approximately $324.0 million, which is expected to support operations until post-launch positive cash flow [1][6] - Selling, General and Administrative (SG&A) expenses increased significantly to $27.6 million for Q3 2025, compared to $6.5 million in Q3 2024, primarily due to increased personnel and marketing expenses [7] - Research and Development (R&D) expenses decreased to $3.8 million for Q3 2025, down from $6.5 million in Q3 2024, reflecting the completion of clinical trials [8] Net Loss - The net loss for the three months ended September 30, 2025, was $16.7 million, compared to a net loss of $10.2 million during the same period in 2024 [9][22] - For the nine months ended September 30, 2025, the net loss was $46.2 million, compared to $37.1 million in the same period in 2024 [9][22]

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 Viewpoint - LENZ Therapeutics is focused on the commercialization of VIZZ™, the first FDA-approved aceclidine-based eye drop for treating presbyopia, and will participate in several upcoming investor and medical conferences to present VIZZ [1][11]. Company Information - LENZ Therapeutics is headquartered in San Diego, California, and is dedicated to providing access to VIZZ globally through licensing partnerships [11]. - The company is targeting a significant market, with presbyopia affecting approximately 1.8 billion people worldwide and 128 million in the United States [11]. 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 [7]. - The product works by causing contraction of the iris sphincter muscle, creating a pinhole effect that enhances depth of focus [7]. Upcoming Conferences - LENZ Therapeutics will participate in several conferences, including: - Citi's 2025 BioPharma Back to School Conference on September 2-3, 2025, in Boston, MA [2]. - Cantor Global Healthcare Conference on September 4, 2025, in New York City, NY [2]. - H.C. Wainwright 27 Annual Global Investment Conference on September 9, 2025, in New York City, NY [2]. - Morgan Stanley 23 Annual Global Healthcare Conference on September 10, 2025, in New York City, NY [3]. - Academy 2025 on October 8-9, 2025, in Boston, MA, featuring presentations on the efficacy of VIZZ [4].

Core Viewpoint - LENZ Therapeutics has received FDA approval for VIZZ, the first aceclidine-based eye drop for treating presbyopia, which affects approximately 128 million adults in the U.S. This product is expected to be available in the U.S. by October 2025, with a once-daily dosing regimen that provides near vision improvement for up to 10 hours [1][2][12]. Group 1: Product Information - 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 [8][9]. - The mechanism of action involves contracting the iris sphincter muscle to create a pinhole effect, enhancing depth of focus without causing a myopic shift [2][8]. - The FDA approval was based on three Phase 3 studies, demonstrating significant near vision improvement within 30 minutes and lasting up to 10 hours [3][4]. Group 2: Clinical Trials and Efficacy - In the CLARITY 1 and CLARITY 2 studies, VIZZ met all primary and secondary endpoints for near vision improvement, with consistent results across both trials [4]. - The trials involved 466 participants in CLARITY 1 and CLARITY 2, and 217 participants in CLARITY 3, which assessed long-term safety over six months [3][4]. - VIZZ was well-tolerated, with no serious treatment-related adverse events reported during over 30,000 treatment days [4][11]. Group 3: Market Impact and Future Plans - The approval of VIZZ is seen as a transformative advancement in treatment options for presbyopia, potentially becoming the standard of care for optometrists and ophthalmologists [2][3]. - The company plans to initiate direct-to-eye care professional sales and marketing activities immediately following the approval [1][2]. - LENZ Therapeutics aims to establish international licensing partnerships to expand access to VIZZ globally [12].