MALVERN, PA — NexEos Bio Vision Health said that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to begin a Phase II/III clinical trial of NTX-1024 for the treatment of vernal keratoconjunctivitis, a rare inflammatory eye disease.
The Malvern-based, privately held biopharmaceutical company said the planned trial will be a single, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of NTX-1024 ophthalmic solution in patients with VKC.
The FDA’s clearance follows results from an open-label, investigator-initiated study conducted in Mexico involving 15 adults with mild to moderate VKC. Participants received NTX-1024 eye drops four times daily for four weeks.
According to the company, the study showed improvements in patient-reported symptoms, including itching and quality of life, and reductions in clinical signs of inflammation such as hyperemia and corneal fluorescein staining. NexEos said the treatment was found to be safe and well-tolerated.
On January 16, 2026, the FDA granted Orphan Drug Designation to NTX-1024 for VKC, a status intended to encourage development of treatments for rare diseases.
“Clearance of our IND application, which included data from our open-label investigator-initiated study in Mexico, is an important and meaningful step for the program,” Steve Tullman, CEO and chairman of NexEos, said in a statement. He added that the company plans to initiate the Phase II/III trial in the second half of this year.
VKC is a chronic, eosinophil-driven ocular inflammatory disease that primarily affects children, though about 10% of cases persist into adulthood. If uncontrolled, it can lead to severe eye damage and permanent vision loss.
Activated eosinophils release toxic granule proteins that can damage the ocular surface, according to published research cited in the company’s announcement.
NTX-1024 is a topical ophthalmic solution designed to target inflammation mediated by eosinophil cationic proteins in rare forms of allergic conjunctivitis, including VKC and atopic keratoconjunctivitis.
NexEos Bio Vision Health said it is developing therapies and diagnostics for eosinophil-mediated diseases and is based in Malvern, Pennsylvania.
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