FDA Events for Sight Sciences (SGHT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Sight Sciences (SGHT).
Over the past two years, Sight Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TearCare. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TearCare System - FDA Regulatory Timeline and Events
TearCare System is a drug developed by Sight Sciences for the following indication: Meibomian Gland Dysfunction (MGD).
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:
- TearCare System
- Announced Date:
- December 19, 2024
- Indication:
- Meibomian Gland Dysfunction (MGD)
Announcement
Sight Sciences, Inc. announced the results of a Budget Impact Analysis ("BIA") of the TearCare® System ("TearCare") for the treatment of MGD-associated dry eye disease ("DED") in the United States.
AI Summary
Sight Sciences, Inc. announced the results of a Budget Impact Analysis (BIA) evaluating the TearCare® System for treating meibomian gland dysfunction (MGD)-associated dry eye disease (DED) in U.S. adults. The study compared TearCare’s financial impact to that of prescription dry eye medications such as Restasis and Xiidra. It found that a 20% increase in TearCare’s market share could lead to an estimated annual savings of about $36.87 per member in a hypothetical health plan covering one million people. The analysis focused on patients with moderate to severe dry eye, highlighting that switching from medications to TearCare is associated with meaningful cost savings for U.S. payers. These results support the idea that payors could benefit from covering TearCare at an appropriate reimbursement level, offering a promising cost-effective alternative for patients suffering from MGD-associated DED.
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Sight Sciences FDA Events - Frequently Asked Questions
As of now, Sight Sciences (SGHT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sight Sciences (SGHT) has reported FDA regulatory activity for TearCare System.
The most recent FDA-related event for Sight Sciences occurred on December 19, 2024, involving TearCare System. The update was categorized as "Results," with the company reporting: "Sight Sciences, Inc. announced the results of a Budget Impact Analysis ("BIA") of the TearCare® System ("TearCare") for the treatment of MGD-associated dry eye disease ("DED") in the United States."
Currently, Sight Sciences has one therapy (TearCare System) targeting the following condition: Meibomian Gland Dysfunction (MGD).
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SGHT) was last updated on 7/10/2025 by MarketBeat.com Staff
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