LENZ Therapeutics: Positioning for Dominance in the Presbyopia Market Post-FDA Approval

LENZ Therapeutics has emerged as a transformative force in ophthalmology with the July 31, 2025, FDA approval of VIZZ (aceclidine ophthalmic solution) 1.44%, the first and only aceclidine-based eye drop for presbyopia treatment according to the company. This milestone not only addresses a significant unmet medical need-improving near vision in adults-but also positions the company to capitalize on a $128 million U.S. market as reported by LENZ. With VIZZ's rapid onset of action (within 30 minutes), 10-hour duration, and preservative-free formulation, LENZ has set a new standard for presbyopia care. However, the true test of its long-term success lies in its ability to execute a robust commercialization strategy and scale globally.

Strategic U.S. Commercialization: Leveraging Partnerships and Brand Power

LENZ's U.S. launch strategy is anchored on two pillars: sample distribution and direct-to-consumer (DTC) marketing. The company anticipates distributing VIZZ samples to Eye Care Professionals (ECPs) as early as October 2025, with commercial availability by mid-Q4 2025. This rapid rollout aims to generate early adoption among ophthalmologists and optometrists, who will play a critical role in prescribing the treatment.

Equally compelling is the DTC campaign, led by actress Sarah Jessica Parker, scheduled to launch in Q1 2026 as announced by LENZ. Parker's involvement-a strategic move to tap into her established credibility in health and wellness-signals LENZ's intent to reframe presbyopia as a manageable condition rather than an inevitable part of aging. According to company reports, this campaign will emphasize VIZZ's convenience and efficacy, targeting a demographic that values both medical innovation and lifestyle enhancement.

Partnerships further bolster this strategy. LENZ's collaboration with Laboratoires Théa for Canadian commercialization, which includes over $70 million in upfront and milestone payments as detailed in the company's Q3 report, underscores its focus on leveraging regional expertise to minimize operational overhead while maximizing market penetration.

Global Expansion: Building a Multiregional Footprint

LENZ's global ambitions are evident in its regulatory and commercialization partnerships. The most significant of these is the exclusive agreement with Lotus Pharmaceutical for South Korea and Southeast Asia. In December 2025, Lotus submitted a New Drug Application (NDA) to South Korea's Ministry of Food and Drug Safety (MFDS), supported by positive Phase 3 CLARITY trial data from the U.S. According to clinical trial results, these trials demonstrated VIZZ's ability to improve near vision within 30 minutes and maintain results for up to 10 hours, with mild and transient adverse effects such as instillation site irritation and dim vision.

The partnership with Lotus is financially lucrative for LENZ, offering up to $125 million in regulatory and commercial milestone payments, in addition to tiered, double-digit royalties on future net sales as outlined in the agreement. This structure aligns with industry best practices, allowing LENZ to defer upfront costs while securing substantial upside. Lotus's existing commercial infrastructure in the region further reduces time-to-market risks, enabling a swift launch in South Korea and expansion into seven Southeast Asian countries by mid-decade as reported in the company's filings.

Financial and Market Implications

The financial terms of LENZ's partnerships highlight its potential to generate recurring revenue streams. For instance, the Lotus agreement alone could yield $125 million in milestone payments, while the Théa partnership adds another $70 million as detailed in the company's financial disclosures. These figures, combined with VIZZ's projected U.S. commercial availability in mid-2025, suggest a rapid monetization path.

From a market access perspective, VIZZ's FDA approval provides a critical credibility boost for international regulatory submissions. According to clinical data, the positive Phase 3 data, which showed no serious treatment-related adverse events over 30,000 treatment days, strengthens LENZ's case for approvals in other regions. This is particularly relevant in markets like South Korea, where demand for non-surgical presbyopia treatments is growing due to aging populations and rising healthcare standards.

Conclusion: A High-Conviction Investment

LENZ Therapeutics' post-FDA approval trajectory reflects a well-calibrated strategy to dominate the presbyopia market. By combining aggressive U.S. commercialization, high-profile DTC campaigns, and strategic global partnerships, the company is poised to capture market share in both developed and emerging economies. The financial terms of its licensing agreements further insulate it from operational risks while providing clear upside potential. For investors, LENZ represents a rare confluence of medical innovation, regulatory momentum, and scalable commercial execution-a compelling case for long-term growth in a $128 million U.S. market as confirmed by the company with global expansion opportunities.