This section highlights FDA-related milestones and regulatory updates for drugs developed by Alcon (ALC).
Over the past two years, Alcon has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BRYTLY and TRYPTYR. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
BRYTLY FDA Regulatory Events
BRYTLY is a drug developed by Alcon for the following indication: Redness Relief Eye Drops.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BRYTLY
- Announced Date:
- October 16, 2026
- Indication:
- Redness Relief Eye Drops
Announcement
Alcon announced that the U.S. Food and Drug Administration (FDA) has approved BRYTLY® Redness Reliever Eye Drops. With one drop, BRYTLY works in just one minute to significantly reduce redness and delivers up to 12 hours of whiter, brighter-looking eyes.
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TRYPTYR FDA Regulatory Events
TRYPTYR is a drug developed by Alcon for the following indication: For the Treatment of the Signs and Symptoms of Dry Eye Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TRYPTYR
- Announced Date:
- May 28, 2025
- Indication:
- For the Treatment of the Signs and Symptoms of Dry Eye Disease
Announcement
Alcon announced the U.S. Food and Drug Administration (FDA) has approved TRYPTYR® (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of Dry Eye Disease (DED).3
AI Summary
Alcon announced that the U.S. Food and Drug Administration (FDA) has approved TRYPTYR® (acoltremon ophthalmic solution) 0.003% for the treatment of signs and symptoms of Dry Eye Disease (DED). TRYPTYR is a first-in-class TRPM8 receptor agonist that works by stimulating corneal sensory nerves to increase natural tear production quickly. Clinical trials demonstrated significant and rapid results, with improved tear production evident as early as Day 1, and persistent benefits observed through Day 90.
This new approval marks a major advancement for DED treatment, offering a promising option for patients who suffer from a condition affecting millions in the U.S., many of whom struggle with current therapies that are slow to act or less effective. TRYPTYR is administered as an eye drop in a single-dose vial, designed for easy use twice daily, potentially improving the quality of life for those with dry eye symptoms.
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