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Alcon has gained its first FDA nod for a prescription product since its 2019 split with Novartis, securing an approval for dry eye disease treatment Tryptyr. Six years after being spun out from Novartis and becoming a public company, eye care specialist Alcon has gained its first FDA approval for a prescription drug, scoring a nod for dry eye disease (DED) treatment Tryptyr (acoltremon ophthalmic solution).Tryptyr, which is administered as a single drop twice daily, is a first-in-class TRPM8 receptor agonist intended to activate tear production. “Tryptyr is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of (DED),” Marjan Farid, M.D., professor of ophthalmology at the University of California, Irvine, said in a release.There are roughly 38 million in the U.S. who have DED. Fewer than 10% of those who have been diagnosed are being treated with a prescription product, according to Alcon.“We believe Tryptyr is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy,” David Endicott, CEO of Alcon, said in a release, adding that the approval was a “tremendous milestone” for the 80-year-old company. The company said it expects to launch Tryptyr in the third quarter.Backing the nod were two phase 3 trials that included more than 930 DED patients. In one study, 43% of patients on Tryptyr had a 10-millimeter increase in natural tear production on the Schirmer test at Day 14, compared to 8% of those on vehicle. In another study, the figures came in at 53% versus 14%, favoring the Tryptyr arm.After operating as a Novartis subsidiary for eight years, Alcon split from the Swiss pharma giant in 2019. Since then, Alcon has been on a growth splurge. In 2022, it paid $770 million to acquire Aerie Pharmaceuticals and its marketed glaucoma and ocular hypertension meds Rhopressa and Rocklatan. The company also ponied up $355 million to gain U.S. rights to Novartis’ Simbrinza, which treats the same ocular conditions. Also in 2022, Alcon gained DED treatment Eysuvis as part of a $60 million transaction with struggling Kala Pharmaceuticals.In addition, two months ago, Alcon secured a majority stake in clinical-stage company Aurion Biotech.In February, Alcon reported 2024 revenue at $9.8 billion, which was up 5% from the prior year.