A groundbreaking advancement in ophthalmology has arrived with the U.S. Food and Drug Administration's recent endorsement of LENZ Therapeutics' innovative eye drop, VIZZ. This marks a pivotal moment for millions grappling with age-related blurred near vision, as VIZZ stands as the inaugural FDA-sanctioned aceclidine-based solution for presbyopia. The drug's efficacy, demonstrated through rigorous clinical trials, offers a promising alternative for those seeking improved visual clarity, with initial distribution anticipated later in 2025.
On Thursday, LENZ Therapeutics received the official green light from the FDA for its VIZZ ophthalmic solution. Known previously as LNZ100, this 1.44% aceclidine-based eye drop is specifically designed to address presbyopia, a common age-related condition that diminishes the eye's ability to focus on close objects. This approval signifies a significant leap forward in eye care, bringing a novel treatment option to a condition that impacts a vast segment of the adult population.
The mechanism behind VIZZ's effectiveness lies in its ability to contract the iris sphincter muscle. This action creates a 'pinhole effect,' which uniquely extends the depth of focus, thereby enhancing near vision without inducing myopia. As the first new chemical entity of its kind approved in the U.S. for presbyopia treatment, VIZZ offers a once-daily solution. Clinical data from three Phase 3 studies, CLARITY 1, CLARITY 2, and CLARITY 3, supported its approval. These trials, involving hundreds of participants, consistently showed that VIZZ improved near vision within 30 minutes of application, with effects enduring for up to 10 hours. Furthermore, the treatment was generally well-tolerated, with most reported adverse reactions being mild, temporary, and self-resolving, including minor irritation, dim vision, and headaches.
Looking ahead, LENZ Therapeutics is poised for a strategic rollout of VIZZ. Samples are expected to be available to eye care professionals in the U.S. as early as October 2025, with a broader commercial launch planned for the middle of the fourth quarter of 2025. Beyond the U.S. market, LENZ has already forged significant partnerships. In May 2025, an exclusive licensing agreement was secured with Lotus Pharmaceutical, granting them commercialization rights for LNZ100 across South Korea and several Southeast Asian nations. This deal could bring in up to $125 million in milestone payments, along with double-digit royalties on net sales. Similarly, in July 2025, Laboratoires Théa obtained rights to register and commercialize LNZ100 in Canada, a collaboration that could yield over $70 million in upfront and milestone payments, plus tiered royalties. Financially, LENZ Therapeutics reported a robust cash position of $209.6 million as of June 30, 2025, which is projected to sustain operations and generate positive cash flow following the product's launch.
This FDA approval represents a monumental achievement for LENZ Therapeutics and a beacon of hope for the millions affected by presbyopia, promising enhanced visual acuity and an improved quality of life.