Can Stem Cells Help With Dry Eye Disease?

What This Article Covers

Dry eye disease affects tens of millions of people and remains frustratingly hard to manage with drops, punctal plugs, or anti-inflammatory medications alone once it becomes chronic or severe. In recent years, researchers have begun testing whether mesenchymal stem cells (MSCs) and MSC-derived exosomes — delivered as eye drops or injected near the lacrimal gland — can calm the underlying inflammation and restore tear production. The early data are genuinely encouraging in small trials, but no stem cell or exosome product is FDA-approved for dry eye disease, and this article lays out exactly what has (and hasn't) been shown so far.

Overview

Dry eye disease is a chronic condition in which the eye fails to produce enough tears (aqueous-deficient dry eye) or the tears evaporate too quickly because of unstable oil film (evaporative dry eye, often tied to meibomian gland dysfunction). Many people have a mix of both. Causes range from aging and screen use to autoimmune conditions — Sjögren's syndrome being the best-known, though it accounts for only a subset of cases and is covered in its own dedicated article on this site. A widely cited U.S. analysis estimated that about 6.8% of American adults — roughly 16.4 million people — have diagnosed dry eye disease, with prevalence rising sharply with age (Farrand et al., American Journal of Ophthalmology, 2017). Left untreated, chronic dry eye can cause persistent discomfort, blurred vision, and in severe cases, corneal damage.

How It's Thought to Work

Conventional dry eye treatments mostly lubricate the surface or dampen inflammation. Stem cell approaches aim at something more upstream: MSCs are thought to act largely through paracrine signaling rather than by physically replacing damaged tissue. When MSCs or their secreted exosomes reach the ocular surface or lacrimal gland, they appear to release anti-inflammatory and trophic factors that can suppress Th17-driven inflammatory pathways, lower pro-inflammatory cytokines such as IL-6 and IL-17A, and support the gland's own tear-producing and mucin-secreting cells. In principle, this could address the inflammatory cycle that perpetuates dry eye rather than just masking symptoms — which is why researchers have been exploring both injected MSCs (aimed at lacrimal gland function) and topical MSC-exosome eye drops (aimed at the ocular surface directly).

What the Evidence Shows

The most rigorous data so far come from a randomized, double-blind clinical trial in patients with Sjögren's syndrome-associated dry eye disease. Møller-Hansen and colleagues injected allogeneic adipose-derived MSCs into the lacrimal gland of one eye in 20 patients, compared against a vehicle-injection group (n=20) and a non-randomized observation group (n=14). At 12 months, the MSC group showed roughly a 40% reduction in Ocular Surface Disease Index (OSDI) symptom scores and improved tear film stability compared with the observation group, though both intervention arms improved relative to observation, raising questions about how much benefit came from the injection itself versus the MSCs (Ocular Surface, 2024;31:1-8; registered as ClinicalTrials.gov NCT04615455).

A separate first-in-human pilot study tested topical MSC eye drops rather than injections: 16 patients with refractory dry eye (11 without Sjögren's, 5 with it) received twice-daily umbilical cord-derived MSC eye drops for two weeks. Researchers reported significant improvements in tear production and ocular surface damage at four weeks, with benefits sustained at one year in the non-Sjögren's group, alongside reductions in inflammatory markers. No serious adverse events occurred — only mild, transient eye discomfort (Zhang et al., Stem Cell Research & Therapy, 2025;16(1):202; ClinicalTrials.gov NCT05784519). This trial was open-label with no control arm, so placebo and natural-fluctuation effects cannot be ruled out.

Exosome-specific research is at an earlier stage: a registered Phase 1/2 trial is testing pluripotent stem cell-derived MSC exosome (PSC-MSC-Exo) eye drops in a small cohort of patients with dry eye following refractive surgery or associated with blepharospasm (ClinicalTrials.gov NCT05738629), but results are not yet available.

Who Might Be a Candidate

Based strictly on where research currently stands, people most likely to be enrolled in or considered for ongoing clinical trials include:

• Adults with moderate-to-severe dry eye disease that has not responded adequately to standard therapies (artificial tears, cyclosporine, lifitegrast, punctal plugs)
• Patients with Sjögren's syndrome-associated dry eye, where several trials have concentrated
• Patients with refractory dry eye following refractive surgery, in early-stage exosome trials
• Anyone considering this route should do so only through an IRB-approved clinical trial, not a commercial clinic offering unregulated injections or drops

Bottom Line

Early trial data on MSC-based approaches to dry eye disease — both injected near the lacrimal gland and formulated as topical exosome-rich eye drops — show real, measurable improvements in validated symptom and tear-function scores, with good short-term safety in the handful of studies conducted so far. That is meaningfully promising for a condition with limited treatment options. But the evidence base remains small, often uncontrolled or only partially controlled, and short in follow-up duration. No MSC or exosome therapy is FDA-approved for dry eye disease, and people should be wary of any clinic marketing such treatments outside a registered clinical trial.