Lupin to Commercialize YUVEZZI Eye Drops for Presbyopia Across Key European Markets

The agreement covers the European Union, the United Kingdom, Switzerland, Norway and Iceland.

Under the agreement, VISUfarma will have exclusive rights to undertake regulatory activities, commercialization, marketing, promotion, distribution and sale of YUVEZZI™ across the licensed territories.

The agreement will remain valid on a country-by-country basis until the 20th anniversary of the date of the first commercial sale of YUVEZZI™ in the respective country, subject to earlier termination in accordance with its terms. Following the initial term, VISUfarma will have the right, at its sole discretion, to renew the agreement in each country for one or more successive five-year periods.

The total potential consideration under the agreement is up to €75 million through to first commercial sales in the licensed territories. This comprises a €20 million strategic investment in the capital stock of Visus or its parent entity through a SAFE (Simple Agreement for Future Equity) instrument, along with up to €55 million in regulatory and commercial milestone payments.

The SAFE instrument provides the right to receive capital stock of Visus or its parent entity upon specified equity financing or public listing events.

In addition, the agreement includes royalty payments based on net sales and sales milestone payments upon achievement of specified sales thresholds in the licensed territories. Milestone payments are contingent upon regulatory submissions, approvals and other specified commercial milestones for YUVEZZI™.

The transaction does not fall within the ambit of related-party transactions, and none of the promoter, promoter group or group companies have any interest in the arrangement.

Visus is a biopharmaceutical company focused on developing eye-care drugs for the aging eye and is affiliated with Tenpoint Therapeutics Holding Limited through a parent holding company structure. Its lead commercial asset is YUVEZZI™, an FDA-approved treatment for presbyopia.

Lupin said the exclusive commercialization rights for YUVEZZI™ in Europe will strengthen its ophthalmology portfolio, expand its Specialty Business presence and create long-term growth opportunities in the presbyopia treatment market across the licensed territories.

“We are delighted to partner with Tenpoint Therapeutics to bring a novel ophthalmic therapy that advances our Specialty Care strategy,” said Vinita Gupta, Chief Executive Officer, Lupin.

She added that, building on Lupin's strategic acquisition of VISUfarma, the partnership further strengthens its vision-care franchise and expands its presence across key European markets.

According to Gupta, the addition of YUVEZZI™ underscores Lupin's commitment to broadening access to differentiated therapies, improving patient outcomes and reinforcing its leadership in eye care across the licensed territories.

Henric Bjarke, Chief Executive Officer, Tenpoint, said the partnership marks an important step for the company as it continues to work toward making YUVEZZI™ available to millions of patients with presbyopia and eye-care professionals worldwide.

He said Lupin's strong commercial operations span major European markets, while VISUfarma's longstanding presence in eye care makes the companies an excellent partner for Tenpoint.

YUVEZZI™ is described as the first and only approved once-daily, dual-agent eye drop for presbyopia. Its addition is expected to enhance Lupin's ophthalmology portfolio and support its strategy of expanding its Specialty Care business through innovative therapies addressing significant unmet patient needs.

Tenpoint is advancing the commercialization of YUVEZZI™ in the United States following its recent U.S. FDA approval. The company is also expanding the product's reach through strategic regional partnerships worldwide.

Tenpoint has already submitted a marketing authorization application in the UK through the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure and plans to pursue regulatory applications for YUVEZZI™ in other key regions.

YUVEZZI™ (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% is a once-daily, dual-agent eye drop approved by the U.S. FDA for the treatment of presbyopia, a condition characterized by the gradual loss of near-vision acuity that typically begins around age 45.

The product combines carbachol and brimonidine, which work together to improve close-up vision. Carbachol helps constrict the pupils, making it easier to focus up close, while brimonidine helps prevent excessive pupil dilation.

YUVEZZI™ should not be used by individuals allergic to any of its ingredients or those who currently have inflammation of the iris (iritis). Patients should inform their doctor before using YUVEZZI™ if they have depression, low blood pressure or circulation problems.

The product may cause temporary blurry, dim or dark vision. Individuals experiencing these effects should avoid driving, operating machinery or participating in hazardous activities and should exercise caution when driving at night or engaging in other activities in low-light conditions.

Patients should contact their doctor immediately if they suddenly experience flashes of light, floaters or vision loss. The tip of the vial should not touch the eye, eyelid or any other surface.

The most common side effects include headache, impaired vision, and temporary eye pain and/or eye irritation upon use. Most side effects were generally mild, short-lived and resolved on their own, according to the company.

Lupin Limited is headquartered in Mumbai and has a presence across India, the U.S., other developed markets and emerging markets, with products distributed in more than 100 countries. Its portfolio includes generics, complex generics, specialty medicines and biosimilars.

The company has 15 manufacturing facilities, six research centers and more than 26,000 employees globally.

Tenpoint Therapeutics Ltd. is a commercial-stage ophthalmic pharmaceutical company focused on the commercialization of YUVEZZI™ for the treatment of presbyopia. The company said presbyopia affects nearly 128 million people in the U.S. and approximately 2 billion people globally.