LENZ Therapeutics and Lotus Pharmaceutical have announced an exclusive license and commercialization agreement for LNZ100, a novel presbyopia treatment, in the Republic of Korea and several Southeast Asian countries. The deal, announced on May 9, 2025, includes up to $125 million in upfront and milestone payments to LENZ, along with tiered double-digit royalties on future net sales.
Under the terms of the agreement, Lotus will gain exclusive rights for development, manufacturing, registration, and commercialization of LNZ100 in Korea and seven Southeast Asian countries, including Thailand, Philippines, Vietnam, Malaysia, Brunei, Indonesia, and Singapore. This region represents a significant market opportunity, with more than 100 million people affected by presbyopia.
LNZ100 is positioned as the first and only aceclidine-based eye drop designed to improve near vision in people with presbyopia, a condition that typically develops with age and affects the eye's ability to focus on nearby objects.
Regulatory Progress and Market Potential
The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for LNZ100 in October 2024 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025. The FDA has indicated it does not plan to hold an Advisory Committee Meeting to discuss the application, potentially streamlining the approval process.
Presbyopia affects an estimated 1.8 billion people globally, including 128 million in the United States alone, representing a substantial unmet medical need and commercial opportunity. Current treatment options are limited, typically involving reading glasses or contact lenses.
Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics, highlighted the strategic importance of the partnership: "We are very excited to partner with the team at Lotus to bring LNZ100 to Southeast Asia, given their proven track record for successful global partnerships, robust commercial infrastructure in the region, and six consecutive years of double-digit revenue growth, now exceeding USD $500 million."
Product Profile and Clinical Development
LNZ100 is a preservative-free, single-use, once-daily eye drop containing aceclidine. The product was evaluated in the registration-enabling Phase 3 CLARITY study as a potential therapy for presbyopia. LENZ's corporate vision for the product is to provide an "all eyes, all day" solution for presbyopia patients.
The company has not publicly disclosed detailed efficacy data from the CLARITY trial, but the FDA's acceptance of the NDA suggests the clinical data package met regulatory requirements for review.
Strategic Importance for Both Companies
For LENZ Therapeutics, a pre-commercial stage biopharmaceutical company based in San Diego, California, this agreement represents a significant step in their global commercialization strategy. Schimmelpennink noted that the company is "committed to partnering with leading commercial pharmaceutical companies ex-US, providing access to LNZ100 for patients worldwide."
Petar Vazharov, Chief Executive Officer of Lotus Pharmaceutical, emphasized the transformative potential of LNZ100: "We are very pleased to be the trusted partner of LENZ to help bring such a transformative product that will significantly enhance the lives of more than 100 million people in this region who are currently impacted by presbyopia."
Lotus Pharmaceutical, founded in 1966 and headquartered in Taiwan, brings substantial regional expertise to the partnership. The company has established a strong presence across Asia with a best-in-class R&D and manufacturing platform certified by leading regulatory authorities worldwide, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA.
Market Access and Commercial Strategy
Lotus plans to leverage its extensive network of channels to ensure access to LNZ100 across the licensed territories. The company's commercial infrastructure and experience in the region position it well to navigate the diverse regulatory environments across Southeast Asian markets.
"Our commitment to excellence drives us to diligently pursue the necessary regulatory approvals and eventually leverage our extensive network of channels to ensure seamless access to this life-altering solution," Vazharov stated.
This partnership adds to Lotus's growing portfolio, which currently includes over 250 commercial products. The company has been developing and registering more than 100 strategically selected pharmaceutical projects across Asia and the U.S., spanning high-barrier oncology, complex generics, 505(b)2 products, new chemical entities, and biosimilars.
Future Outlook
As LENZ awaits the FDA decision on LNZ100 in August 2025, this partnership positions the company to rapidly expand into Asian markets following potential U.S. approval. The agreement with Lotus represents an important validation of LNZ100's commercial potential and could serve as a template for additional ex-US partnerships.
For patients with presbyopia in Southeast Asia, the collaboration between LENZ and Lotus may soon provide access to a novel pharmaceutical option beyond traditional corrective lenses, potentially improving quality of life for millions of people affected by this common age-related condition.
