Alcon Secures First FDA Approval Since Novartis Spin-Off In 2019

The U.S. Food and Drug Administration (FDA) on Wednesday approved Alcon Plc’s ALC Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for signs and symptoms of Dry Eye Disease (DED).

Alcon produces contact lenses, dry eye drops, gels and other related products.

Tryptyr is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates corneal sensory nerves to increase natural tear production.

Also Read: FDA Rejects Aldeyra’s Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns

DED is a complex, multifactorial condition driven by a deficiency in natural tears, whether due to decreased tear production or increased tear evaporation. It is one of the most common ocular surface disorders, affecting an estimated 38 million adults in the U.S. and an estimated 719 million more adults globally.

“Today marks a tremendous milestone for Alcon as Tryptyr becomes our first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company,” said David Endicott, CEO of Alcon.

The approval is supported by two Phase 3 clinical trials evaluating more than 930 patients.

In COMET-2 and COMET-3, up to four times more Tryptyr patients experienced at least a 10mm increase in natural tear production at Day 14, compared to vehicle, 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both p<0.0001).

Consistent results were observed at all time points through Day 90. Tryptyr demonstrated statistically significant natural tear production as early as Day 1.

Tryptyr is available in easy-to-use, single-dose vials: one drop per eye, two times a day. Alcon expects to launch Tryptyr in the U.S. in the third quarter of 2025.

Other FDA-approved treatments for DED include Alcon’s Eysuvis and Bausch + Lomb Corp’s BLCO Xiidra.

In April, the FDA issued a Complete Response Letter for Aldeyra Therapeutics, Inc.’s LADX resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate for dry eye disease.

In March, Alcon agreed to acquire LENSAR Inc LNSR for $14.00 per share in cash for an aggregate implied value of approximately $356 million.

The deal also has an additional non-tradeable contingent value right offering of up to $2.75 per share in cash. The transaction represents a total consideration of up to approximately $430 million.

Price Action: ALC stock is up 0.47% at $85.79 at the last check on Thursday

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