NexEos Bio Announces FDA Clearance of IND Application to Proceed to Phase II/III Trial of NTX-1024 in Vernal Keratoconjunctivitis

MALVERN, Pa.–(BUSINESS WIRE)–NexEos Bio Vision Health (“NexEos”), a clinical-stage biopharmaceutical company developing novel therapies and diagnostics targeting eosinophil-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared NexEos’s Investigational New Drug (IND) 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.

This is on the heels of the positive results reported 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. These results reinforce the therapeutic potential of NTX-1024 in VKC and have prompted NexEos to pursue further clinical development.

In addition, on January 16, 2026, the FDA granted Orphan Drug Designation to NTX-1024 for VKC.

“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,” said Steve Tullman, CEO and Chairman of NexEos. “We are excited to advance clinical development of NTX-1024, which would be the first, ophthalmic therapeutic to neutralizes eosinophil cationic protein to reduce inflammation in rare forms of Allergic Conjunctivitis – Vernal Keratoconjunctivitis (VKC) and Atopic Keratoconjunctivitis (AKC). We are on track to initiate our Phase II/III clinical trial by the second half of this year, taking us closer to our objective of delivering a best-in-class therapeutic option to patients with VKC.”

About Vernal Keratoconjunctivitis (VKC)

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 (Sacchetti, et al. 2021). VKC primarily affects children although approximately 10% of cases persist into adulthood (Di Zazzo A 2024). Uncontrolled VKC can result in severe ocular damage and permanent vision loss (Vichyanond, et al. 2014).

About NTX-1024 (gleceparin sodium)

NTX-1024 is a novel, topical ophthalmic solution targeting eosinophil cationic protein mediated inflammation in rare forms of allergic conjunctivitis, including VKC and AKC. NTX-1024 has completed proof of concept in VKC, received ODD approval, and now has FDA clearance of its IND application to advance to a Phase II/III clinical trial in VKC. NTX-1024 is the first therapeutic successfully targeting neutralization of eosinophil cationic proteins. Finally, NTX-1024 has the potential to be the first drug to be disease-modifying and steroid-sparing in VKC and AKC.

About NexEos Bio

NexEos Bio (www.nexeosbio.com) is a privately held medical diagnostics and therapeutics company based in Malvern, Pennsylvania, dedicated to improving the detection, diagnosis, treatment and life-long management of patients living with chronic, eosinophil-related inflammatory diseases. Through the licensing, development and commercialization of novel technologies, NexEos Bio is bringing new tools and therapies to market that address the unmet needs of patients suffering from eosinophil-related diseases.

Contacts

For more Information, please send inquiries to: Info@nexeosdx.com