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FDA Clears Expanded Indication for TearCare System to Improve Meibomian Gland Function in Evaporative Dry Eye Disease

The US Food and Drug Administration (FDA) has cleared an expanded label for the TearCare heat therapy system (Sight Sciences) specifically targeting the restoration of meibomian gland function. According to the manufacturer, the device is indicated to:

Emphasizing the clinical shift toward earlier therapeutic intervention, Matt Gibson, senior director of marketing, interventional dry eye, at Sight Sciences, remarked:

Gibson further noted that the regulatory label:

Regulatory Differentiation and Comparative Indications

While other pharmacologic and device-based interventions have documented functional improvements in the meibomian glands, they do not carry this specific clearance from the FDA.

Table 1. Comparative Analysis of FDA Indications for Selected Dry Eye Therapies

Clinical Trial Evidence

The regulatory expansion was supported by clinical outcomes from two comparative trials: the OLYMPIA study (evaluating TearCare vs LipiFlow) and the SAHARA study (evaluating TearCare vs Restasis). Across both trials, investigators assessed primary and secondary functional endpoints alongside patient-reported symptom scores.

Table 2. Supporting Clinical Trial Framework and Evaluated Endpoints

Regarding these outcome parameters, Gibson stated:

Pathophysiologic Considerations and Clinical Goals

Meibomian gland dysfunction represents a chronic condition requiring targeted therapeutic strategies to prevent terminal anatomical loss. Gibson underscored the urgency of physiological preservation:

He concluded that this disease progression:

Conflict of Interest Disclosures

Matt Gibson reports being senior director of marketing, interventional dry eye, at Sight Sciences.

Incidence of New-Onset Metabolic Syndrome and Related Comorbidities in Men With Prostate Cancer Receiving Concurrent ADT and ARPIs

Based on findings reported by Shaver AL, et al. JAMA Oncol. 2026;doi:10.1001/jamaoncol.2026.2790.

Background and Rationale

Metabolic syndrome—clinically characterized by central adiposity, hypertriglyceridemia, hypertension, insulin resistance, and decreased high-density lipoprotein levels—affects more than one-third of the US adult population, with higher prevalence observed among older demographics. Although oncology practice guidelines recommend combining androgen receptor pathway inhibitors (ARPIs) with androgen deprivation therapy (ADT) for advanced prostate cancer, the exact metabolic liability of this dual regimen remained insufficiently defined.

Dr. Amy L. Shaver, principal biostatistician at Thomas Jefferson University, underscored the clinical trade-off between survival benefits and adverse systemic effects:

“Patients who receive ARPI and ADT have immense benefits to overall survival. However, monitoring for metabolic abnormality needs to happen early and systematically in treatment. It should happen before treatment begins, and then it needs to be watched.”

Shaver also highlighted the inherent risks of therapeutic escalation:

“If you’re adding regimens, that’s something you should know. Every time you put a drug on board with somebody, things can happen.”

Methods and Study Cohort

A retrospective cohort analysis was executed using the Epic Cosmos database, capturing clinical documentation across more than 1,800 hospitals and 41,000 outpatient centers. The cohort comprised 16,924 male patients diagnosed with prostate cancer between January 2014 and September 2025 who initiated combination therapy with ADT and ARPIs and possessed no prior history or clinical indicators of metabolic syndrome or its discrete components. The primary study endpoint was the development of new-onset metabolic syndrome within 12 months of starting concurrent therapy.

Table 1. Baseline Characteristics of the Study Population ($N = 16,924$)

Primary Results and Onset Dynamics

Across 152,905.7 patient-months of accumulated follow-up, 39.1% of patients developed metabolic syndrome within 12 months. Overall, 86.9% developed at least one metabolic dysfunction, corresponding to an event rate of 245.5 per 1,000 person-months.

The median time to the presentation of the first metabolic aberration was 1.0 month (most frequently hypertension), with a median duration of 2.6 months to fulfillment of complete metabolic syndrome criteria.

Regarding the unexpectedly rapid clinical onset, Shaver stated:

“We fully expected that we would see a decent amount of people who developed metabolic syndrome, or had one of the components of metabolic syndrome, but what was surprising was how frequent it was, and how early it happened. I remember when we first had the results, the oncologist who was working with us, he was like, ‘Wow. I know this happens, but to actually see it black and white, this is a lot of people, and it’s quick.’”

Table 2. Cumulative 1-Year Incidence and Rates of Metabolic Comorbidities

Age Stratification

Patients aged 70 to 79 years exhibited the highest 1-year cumulative rate of metabolic syndrome (41.7%), compared with 37.8% among patients aged 80 years and older and 37.2% among those aged 18 to 69 years. Conversely, obesity risk showed an inverse relationship with increasing age.

Table 3. Risk of Metabolic Dysfunctions: Ages 70–79 Years vs 18–69 Years

Comparative ARPI Analysis

An exploratory analysis evaluated the differential risk profiles of individual ARPI agents (enzalutamide and apalutamide) relative to abiraterone acetate.

Shaver emphasized the hypothesis-generating nature of these findings:

“It was exploratory. It’s not what we were specifically looking at. We were trying to see, is there a signal there? Is it something worth looking at? I think so.”

Table 4. Hazard Ratios for Enzalutamide and Apalutamide vs Abiraterone

Discussion and Clinical Implications

The primary limitation acknowledged by investigators was the lack of an ADT-alone control cohort. Shaver observed:

“How much of that burden, how much of that risk can be attributed just to ADT? Just to the addition of the ARPI?”

Dr. Grace Lu-Yao, professor of medical oncology at Sidney Kimmel Medical College, stressed that oncologists and primary care teams must collaborate to prevent non-oncologic morbidity:

“A lot of patients, when they have cancer, they just single-minded focus on cancer and do not think about other potential health issues. Close monitoring plus coordinated care is truly important, because not only do patients have to deal with cancer, but there are other issues related to cancer therapy that could have significant impact on overall health.”

Shaver reinforced the preventive role of targeted surveillance:

“Ideally, after doing studies like this, we can identify who’s at most risk and test interventions that help reduce complications, so that you don’t have somebody who is surviving their prostate cancer but dies of a heart attack.”

As ARPI-based therapies migrate to earlier disease stages where extended survival is common, longitudinal cardiometabolic surveillance becomes critical. As Lu-Yao concluded:

“Some high-risk patients are already using this regimen. Those patients could potentially have 15, 20 years to live. Because of that, it’s even more important to monitor the potential impact of the therapy on their metabolic health.”

The US Department of Health and Human Services (HHS) released a notice of proposed rulemaking intended to rescind and replace existing Head Start Program Performance Standards with a “streamlined” regulatory framework.¹ Characterized by HHS as a “sweeping reform,” the initiative aims to curb administrative expenditures, broaden program participation, and devolve programmatic oversight to state and municipal levels.¹ A key provision of the proposed policy eliminates federal regulatory requirements mandating that enrolled children undergo standardized vision and hearing screenings within 45 days of enrollment, raising concern among pediatric vision health specialists.¹

Policy Framework and Administrative Rationale

The federal proposal seeks to dismantle existing administrative mandates, framing the shift as a reduction in regulatory burden while expanding service capacity.¹

Explaining the intent behind the overhaul, HHS Secretary Robert F. Kennedy Jr. stated:

“We are removing unnecessary bureaucracy, strengthening nutrition and physical health, trusting parents and local communities, and opening Head Start to hundreds of thousands more children.”¹

Under current Head Start Program Performance Standards, operating programs are required to administer “evidence-based vision and hearing screenings” within 45 days of an infant or child entering the program.¹ The proposed rule would formally eliminate this specific timeline and regulatory directive from the administrative code to prevent statutory redundancy with the overarching Head Start Act.¹

Regarding statutory continuity and grantee flexibility, the administrative notice clarified:

“While the proposed regulations would no longer specify that programs must conduct hearing and vision screenings, this requirement will still apply due to statutory requirements. However, programs would have more flexibility on timeline and process for ensuring screenings are completed.”¹

Comparison of Regulatory Standards

The proposed rule shifts programmatic requirements from standardized federal directives to decentralized local administration.¹

Pediatric Advocacy and Legal Considerations

Pediatric eye health specialists raised substantive concerns regarding the downstream clinical and developmental ramifications of removing explicit screening deadlines and protocols.¹

Donna Fishman, MPH, director of the National Center for Children’s Vision and Eye Health at Prevent Blindness, argued that eliminating standardized enforcement mechanisms without structural clarity poses substantial risks:

“without clarity about how the underlying requirement should still be met will inherently reduce the quality, scope and type of services required. Head Start programs may cease conducting vision screenings altogether or may conduct those screenings later in the year, after a child with a vision disorder or vision loss has lost learning opportunities due to poor vision. Additionally, programs may utilize tools and methods that are not evidence based … or age appropriate.”¹

Fishman also questioned the statutory legality of the proposed regulatory rescission under federal law:

“With respect to vision screenings, we believe that rescission of these requirements may potentially violate the Head Start Act, which prohibits (as stated in § 641A(a)(2)(C)(ii) of the Act) any reduction of the ‘quality, scope or type’ of services required to be provided.”¹

Public comment on the proposed rule remains open through October 6, 2026.¹

References

1. Healio. Proposed Head Start rule would remove hearing, vision screening requirements. Published September 10, 2026.