LENZ Therapeutics and Lotus Pharmaceutical have formalised an exclusive licensing and commercialisation agreement, allowing the latter to distribute LNZ100 in South Korea and certain Southeast Asian countries.
This move focuses on addressing presbyopia by offering LNZ100, an aceclidine-based eye drop.
As part of their agreement, LENZ Therapeutics will receive up to $125m through upfront fees and milestone payments, alongside tiered royalties based on net sales.
LENZ Therapeutics, a biopharmaceutical firm based in San Diego, is engaged in developing this novel treatment to improve near vision for those affected by presbyopia. The condition affects approximately 1.8 billion individuals worldwide.
LENZ Therapeutics president and CEO Eef Schimmelpennink said: “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 $500m.
“Upon approval, we look forward to the Lotus team bringing LNZ100 to this important and commercially attractive region.”
“We are committed to partnering with leading commercial pharmaceutical companies ex-US, providing access to LNZ100 for patients worldwide.”
Lotus Pharmaceutical, which is focused on making innovative pharmaceuticals accessible globally, will handle the development, manufacturing, registration, and marketing of LNZ100 in South Korea, Thailand, the Philippines, Vietnam, Malaysia, Brunei, Singapore, and Indonesia.
Lotus Pharmaceutical CEO Petar Vazharov said: “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.
“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.”
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for LNZ100 and set a target action date of 8 August 2025, under the Prescription Drug User Fee Act (PDUFA). The agency will not convene an Advisory Committee Meeting regarding this application.
The LNZ100 product is set to be preservative-free and offered as a single-use, once-daily eye drop.
The CLARITY study evaluated LNZ100 as a potential treatment for presbyopia, indicating the product’s role in addressing an unmet need in vision care.
