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, OMNI, and OMNI. 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.
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:
- August 19, 2026
- Indication:
- Meibomian Gland Dysfunction (MGD)
Announcement
Sight Sciences, Inc announced that, effective August 18, 2026, the U.S. Food and Drug Administration (FDA) updated the TearCare® System (TearCare) Indications for Use to state: "The Sight Sciences TearCare System is a thermal-activated gland expression therapy that improves meibomian gland function in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands."
Read Announcement- Drug:
- TearCare System
- Announced Date:
- July 29, 2025
- Indication:
- Meibomian Gland Dysfunction (MGD)
Announcement
Sight Sciences, Inc. announced that the manuscript detailing 24-month results from Stage 3 of the SAHARA randomized controlled trial (RCT) has been published ahead of print (PAP) by Optometry and Vision Science (Official Journal of the American Academy of Optometry) and is available online in pre-publication format.
AI Summary
Sight Sciences announced that the manuscript detailing the 24-month results from Stage 3 of the SAHARA randomized controlled trial has been published ahead of print by Optometry and Vision Science. The paper is available online in pre-publication format. In the study, all signs and symptoms remained significantly better than baseline at every follow-up through 24 months. Two TearCare® treatments at baseline and Month 5 provided durable relief, and 66% of participants required no further treatment.
Study leaders noted the durability, repeatability, and clinical benefits of the TearCare System. Lead author Dr. John Hovanesian highlighted that just two treatments within five months led to meaningful, lasting relief for up to two years. Improvements in key eye-health measures and patient feedback remained significant at every follow-up. This publication adds to a growing body of evidence supporting TearCare’s long-term effectiveness for dry eye.
Read Announcement- 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.
Read Announcement
OMNI Device FDA Regulatory Events
OMNI Device is a drug developed by Sight Sciences for the following indication: Canal Viscodilation in Combination with Cataract Surgery in Adults with Primary Open-Angle Glaucoma (POAG).
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:
- OMNI Device
- Announced Date:
- November 11, 2025
- Indication:
- Canal Viscodilation in Combination with Cataract Surgery in Adults with Primary Open-Angle Glaucoma (POAG)
Announcement
Sight Sciences, Inc. announced today the results from three key published manuscripts that further demonstrate the value of an interventional mindset in treating glaucoma.
AI Summary
Sight Sciences announced results from three published studies showing that an interventional approach to glaucoma care can lower eye pressure and reduce medication use. In a 24-month prospective study of 18 eyes treated with standalone OMNI, average intraocular pressure (IOP) fell from 26.1 mmHg by about 9.7 mmHg at 12 months and 10.6 mmHg at 24 months, with medications dropping from 1.8 to 0.9 and then 0.5; two-thirds were medication-free at month 24. A large retrospective analysis of nearly 13,000 African American eyes found greater IOP reductions when minimally invasive glaucoma surgery (MIGS) was combined with cataract surgery than with cataract surgery alone, with OMNI showing the highest share of patients achieving ≥20% IOP reduction. A subgroup analysis of 220 eyes showed standalone OMNI lowered IOP for up to three years regardless of lens status or disease severity.
Company leaders and investigators said these findings support using effective interventional tools like OMNI to reduce IOP and dependency on drugs, and to help patient groups at higher risk, including African American patients.
Read Announcement- Drug:
- OMNI Device
- Announced Date:
- September 9, 2025
- Indication:
- Canal Viscodilation in Combination with Cataract Surgery in Adults with Primary Open-Angle Glaucoma (POAG)
Announcement
Sight Sciences, Inc. announced that UnitedHealthcare (UHC) has updated its Glaucoma Surgical Treatments policy to cover goniotomy, trabeculotomy, canaloplasty (ab interno), and combined canaloplasty (ab interno) and trabeculotomy procedures for adults (age 19 years or more), when deemed medically necessary for treating mild to moderate open-angle glaucoma (OAG) and cataract in adults currently being treated with ocular hypotensive medication.
AI Summary
Sight Sciences, Inc. announced that UnitedHealthcare (UHC) has revised its Glaucoma Surgical Treatments policy to cover goniotomy, trabeculotomy, ab interno canaloplasty, and combined ab interno canaloplasty and trabeculotomy for adults aged 19 and older. These procedures will be covered when they are deemed medically necessary for treating mild to moderate open-angle glaucoma (OAG) and cataract in patients already using ocular hypotensive medication.
The updated policy takes effect October 1, 2025, and applies to UHC’s commercial and individual exchange plans. UHC, one of the nation’s largest insurers, covers more than 50 million lives in total, with approximately 30 million under its commercial and individual exchange benefits.
Paul Badawi, Co-Founder and CEO of Sight Sciences, noted that the policy expansion gives UHC members improved access to implant-free, minimally invasive glaucoma surgery (MIGS) technologies, including the FDA-cleared OMNI Surgical System, when their ophthalmologist determines it is medically necessary.
Read Announcement
OMNI Surgical System FDA Regulatory Events
OMNI Surgical System is a drug developed by Sight Sciences for the following indication: Pseudophakic Eyes with Open-Angle Glaucoma.
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:
- OMNI Surgical System
- Announced Date:
- September 17, 2025
- Indication:
- Pseudophakic Eyes with Open-Angle Glaucoma
Announcement
Sight Sciences, Inc. announced the results as published in the European Journal of Ophthalmology of a systematic review and meta-analysis of the clinical effectiveness, safety, humanistic and economic impact of the OMNI Surgical System (OMNI).
AI Summary
Sight Sciences announced results published in the European Journal of Ophthalmology of a systematic review and meta-analysis examining the OMNI Surgical System and its predecessors, Visco360 and Trab360, for treating open-angle glaucoma.
The analysis included 29 publications covering 2,379 eyes. It found that about 89% of patients reached a ≥20% drop in intraocular pressure (IOP) at 6, 12, and 24 months. Around 66–68% of patients were medication-free at those milestones.
Combined with cataract surgery or as a standalone procedure, OMNI lowered IOP to below 18 mmHg at 12 and 24 months. Average medication use fell from 0.9–3.4 drugs at baseline to 0.1–2.2 drugs at one year. Adverse events were mild and short-lived.
Economic data showed OMNI is cost-effective compared to iStent inject®, offering slightly higher quality-adjusted life years due to its favorable safety profile.
Read Announcement
