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
TRYPTYR, UNITY®, and UNITY®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TRYPTYR - FDA Regulatory Timeline and 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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UNITY® Cataract System - FDA Regulatory Timeline and Events
UNITY® Cataract System is a drug developed by Alcon for the following indication: Device study.
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:
- UNITY® Cataract System
- Announced Date:
- June 24, 2024
- Indication:
- Device study
Announcement
Alcon announced that UNITY® Cataract System (CS) have received U.S. Food and Drug Administration (FDA) 510(k) clearance.
AI Summary
Alcon announced that its UNITY® Cataract System (CS) has received FDA 510(k) clearance for use in the United States. This milestone marks an important step in introducing the latest technology from Alcon’s Unity portfolio. The UNITY® CS is designed to improve cataract surgery by offering innovative features that can help enhance surgical efficiency and performance in clinical settings. With this clearance, Alcon will begin collecting real-world feedback from surgeons and other healthcare professionals ahead of its broad commercialization planned for 2025. The new system is expected to bring a significant upgrade to current market-leading technologies, providing benefits for both the surgical team and patients. Overall, the FDA clearance of the UNITY® CS highlights Alcon’s commitment to advancing eye care and improving outcomes in cataract procedures.
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UNITY® Vitreoretinal Cataract System - FDA Regulatory Timeline and Events
UNITY® Vitreoretinal Cataract System is a drug developed by Alcon for the following indication: Device study.
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:
- UNITY® Vitreoretinal Cataract System
- Announced Date:
- June 24, 2024
- Indication:
- Device study
Announcement
Alcon announced that UNITY® Vitreoretinal Cataract System (VCS) have received U.S. Food and Drug Administration (FDA) 510(k) clearance.
AI Summary
Alcon announced that its UNITY® Vitreoretinal Cataract System (VCS) has received U.S. FDA 510(k) clearance. This milestone clearance is part of a new generation of surgical systems from Alcon’s Unity portfolio, aimed at improving the workflow and efficiency of both cataract and vitreoretinal surgeries.
The cleared system, along with the standalone UNITY® Cataract System (CS), introduces innovations designed to enhance clinical performance and patient care. Alcon will start gathering real-world feedback from U.S. users as they prepare for a broad commercial launch in 2025. This initiative demonstrates the company’s commitment to involving Eye Care Professionals and integrating their insights into future product improvements.
By advancing its surgical equipment through such clearances, Alcon aims to continue leading the eye care industry with new technology that benefits both surgeons and patients.
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