FDA Clears Immunoglobulin Eye Drops for Phase II Dry Eye Trial

Biologic therapy enters clinical study to assess broad anti-inflammatory potential

The U.S. FDA has granted IND clearance for a new immunoglobulin (IG) eye drop therapy to treat dry eye disease (DED), enabling Phase II trials led by Selagine, Inc. (Chicago, IL). GRF312 Ophthalmic Solution, developed in partnership with Grifols (Barcelona, Spain), is a plasma-derived biologic designed to reduce ocular surface inflammation across multiple immune pathways.¹

In a first-in-human pilot study conducted at the University of Illinois College of Medicine, GRF312 significantly improved signs and symptoms of DED, and it did so with no red flags on safety or tolerability. The new trial will further evaluate safety and efficacy in a broader patient population.

Addressing inflammation on multiple fronts

GRF312 Ophthalmic Solution, Selagine’s investigational therapy, is designed to address the complex immunopathology of chronic dry eye disease using a plasma-derived therapy that works on multiple immune pathways. Instead of playing whack-a-mole with single immune triggers, this therapy aims to shut down the whole dysfunctional party.

Unlike current therapies that primarily suppress T-cell–driven inflammation, GRF312 works through a broader mechanism of action by leveraging pooled human immunoglobulin (IG) derived from thousands of healthy donors.

The drug is engineered to neutralize pro-inflammatory cytokines, modulate key immune cells including neutrophils, dendritic cells and T-cells, and inhibit the complement system. These pathways are all known to be active in moderate to severe ocular surface inflammation, a hallmark of dry eye disease—especially in patients with autoimmune disorders.

This broad-spectrum immunomodulation may allow GRF312 to provide therapeutic benefit in patients with severe or chronic dry eye, especially those unresponsive to anti-inflammatory eye drops or narrow-acting treatments such as cyclosporine or lifitegrast.¹

“We believe our immunoglobulin eye drops have the potential to make a qualitative leap in how dry eye disease is treated,” said Dr. Jörg Schüttrumpf, Chief Scientific Innovation Officer at Grifols. “We are using our extensive and deep knowledge of immunoglobulins to benefit the millions of patients globally who aren’t receiving sufficient relief.”

In a first-in-human pilot study conducted at the University of Illinois College of Medicine, GRF312 showed a significant reduction in both signs and symptoms of dry eye disease, with no difference in tolerability or adverse events compared to standard treatments. The upcoming Phase II trial will evaluate these outcomes in a larger, multi-center cohort.

[Dry Eye Disease video: https://eyetube.net/spotlight/lumibird-medical/management-of-dry-eye]

Why it matters for dry eye care

DED remains one of the most common and complex ocular conditions seen in clinical practice. It affects an estimated 16 million people in the United States and accounts for up to one-third of all visits to eye care providers. Patients with severe or chronic DED, particularly those with autoimmune disorders like Sjögren’s syndrome, ocular graft-versus-host disease, or Stevens-Johnson syndrome, often report inadequate relief from currently approved therapies.

Inflammation plays a central role in the pathogenesis of dry eye. Yet most available treatments focus on limited targets, such as T-cell inhibition. GRF312 aims to address this treatment gap by offering a multi-pronged anti-inflammatory effect through plasma-derived immunoglobulin.

The therapy’s entry into clinical trials also reflects growing demand for innovation in a category that is both medically significant and commercially sizable. The global dry eye therapeutics market is projected to exceed USD 6.5 billion by 2027, driven by aging populations, increased screen use and rising autoimmune comorbidity rates.

If successful in Phase II, GRF312 could offer an option for patients who are unresponsive to narrow-spectrum agents, while helping expand the clinical toolkit for managing immune-mediated ocular surface disease.

What’s next in the research pipeline

With FDA IND clearance secured, Selagine will initiate a multicenter Phase II clinical trial for dry eye to further assess the safety and efficacy of GRF312 in patients with moderate to severe dry eye disease. Trial enrollment is expected to begin in the third quarter of 2025, with approximately 100 patients participating.¹

The drug is one of eight investigational therapies currently advancing through Phase II trials from the University of Illinois Chicago’s clinical pipeline. GRF312 stands out as the only ophthalmic product among them and reflects the university’s broader push to translate academic research into targeted therapeutic solutions.

If Phase II results support the initial pilot data, Selagine and Grifols plan to pursue pivotal studies and explore expanded ophthalmic indications, including applications in acute ocular injury. If successful, this innovative dry eye treatment could broaden the biologics pipeline in ophthalmology and fill a major gap in care for inflammation-driven ocular conditions.

Editor’s Note: Read the full press release from Selagine and Grifols here.