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Alcon Inc. has received its first Food and Drug Administration approval since its spinoff from Swiss medical giant Novartis in 2019.
Last month, the FDA cleared the company’s Tryptyr ophthalmic solution.
“We look forward to making this new treatment available to millions of patients affected by dry eye disease,” Alcon Chief Executive David Endicott said in a statement.
“We believe TRYPTYR is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy.”
The company, with its headquarters in Switzerland and local operations in Irvine, makes eye drugs and contact lens solutions that compete with homegrown eye and skin drug maker Allergan Inc.
Alcon is the sixth-largest medical device maker in Orange County and is considered to be the largest eye care company in the world, valued at $35.1 billion (NYSE: ALC).
It employs more than 25,000, including roughly 1,500 of whom work at its Irvine and Lake Forest locations.
In 2008, Novartis bought 25% of Alcon from fellow Swiss company Nestlé.
Two years later, it exercised its option to buy 52% for $28.1 billion before gaining full ownership in 2011.
Drug Acquired From $770M Aerie Acquisition
Alcon got the rights to Tryptyr through its $770 million acquisition of Aerie Pharmaceuticals Inc. in 2022.
The transaction helped the company achieve its goal of expanding into the ophthalmic pharmaceutical eye drop space.
At the time, the drug was in Phase 3 clinical trials.
Alcon also acquired the rights to commercialized products in Aerie’s portfolio, including the Rocklatan and Rhopressa eyedrops.
Dry eye disease is a common condition, affecting an estimated 38 million people in the U.S. with less than 10% being treated with a prescription product, according to Alcon.
“Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” Dr. Marjan Farid, professor of ophthalmology at the University of California, Irvine, said in a statement.
An active ingredient in Tryptyr stimulates corneal sensory nerves to “rapidly increase natural tear production.”
The approval comes after two Phase 3 clinical trials evaluating more than 930 patients.
About half of participants were shown to have at least a 10 millimeter increase in natural tear production within 14 days.
Tryptyr comes in single dose vials and is meant to be taken two times day.
The company expects to launch Tryptyr in the third quarter of this year and “anticipates bringing TRYPTYR to other markets in the future.”
Irvine, Lake Forest Footprint
Alcon has 16 major research and development facilities around the globe, including a 40,900-square-foot building in Irvine.
The Spectrum-area facility is owned by Newport Beach-based Irvine Company.
Alcon’s Irvine operations are used to manufacture eye-related surgical equipment, and the company’s current Alton Parkway facilities contain “some of the most sophisticated ophthalmic research and manufacturing activities in the world,” the company has previously stated.
Alcon also has a notable footprint in Lake Forest.
In 2012, Alcon signed an 11-year lease for the entirety of Serrano Creek Center, a 12-acre office campus on Lake Forest Drive that previously was the headquarters of Western Digital Corp., which has since moved to Irvine.