FDA Clears NexEos Bio IND for NTX-1024 Phase II/III Trial in Vernal Keratoconjunctivitis
The FDA cleared NexEos Bio's IND application to proceed with a Phase II/III trial of NTX-1024 ophthalmic solution for vernal keratoconjunctivitis, following positive results from a 15-patient study in Mexico.
The U.S. Food and Drug Administration has cleared NexEos Bio's Investigational New Drug Application to proceed to a Phase II/III clinical trial of NTX-1024 for the treatment of patients with the rare disease, vernal keratoconjunctivitis (VKC). The planned Phase II/III trial is a single, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of NTX-1024 ophthalmic solution in patients with VKC.
The clearance follows positive results from an open-label, investigator-initiated study evaluating the efficacy, safety, and tolerability of NTX-1024 eye drops in adults with VKC. The study was conducted in Mexico and enrolled 15 patients with mild to moderate VKC who received NTX-1024 four times daily over a four-week period. Treatment led to significant improvement in patient-reported symptoms such as itching and quality of life, along with reductions in clinical signs of inflammation, including hyperemia and corneal fluorescein staining. NTX-1024 was also found to be safe and well-tolerated.
This marks the first clinical study to evaluate NTX-1024 in VKC, a rare and severe eosinophil-driven ocular condition that can lead to irreversible ocular damage, including vision loss, if left untreated. NTX-1024 neutralizes the eosinophil cationic protein-mediated inflammation that is involved in vernal keratoconjunctivitis and atopic keratoconjunctivitis.
NTX-1024 would be the first ophthalmic therapeutic to neutralize eosinophil cationic protein to reduce inflammation in rare forms of allergic conjunctivitis, including VKC and AKC. The solution would be positioned as a first-line non-systemic therapy for eosinophilic inflammation in vernal keratoconjunctivitis and is expected to be steroid sparing. Its mechanism is not associated with the long-term safety risks associated with chronic use of corticosteroid eye drops, which increases risk of glaucoma, eye infections and corneal degeneration.
On January 16, 2026, the FDA granted Orphan Drug Designation to NTX-1024 for VKC. NexEos is on track to initiate the Phase II/III clinical trial by the second half of this year.
VKC is a rare, chronic, and vision-threatening ocular inflammatory disease that is predominantly eosinophil-mediated. Activated eosinophils release toxic granule proteins, including eosinophil major basic protein-1 (eMBP1), resulting in damage to the ocular surface. VKC primarily affects children although approximately 10% of cases persist into adulthood. Uncontrolled VKC can result in severe ocular damage and permanent vision loss.