NEXT BIOMEDICAL and NexEos Bio Reach FDA Milestones

NEXT BIOMEDICAL completed the U.S. FDA’s pre-submission process for its vascular embolization device Nexsphere-F under the Total Product Lifecycle Advisory Program (TAP), the company announced Monday. In a separate regulatory development, NexEos Bio received FDA clearance of its Investigational New Drug (IND) application to proceed to a Phase II/III clinical trial of NTX-1024 for the treatment of vernal keratoconjunctivitis (VKC).

For NEXT BIOMEDICAL, the pre-submission review involved submitting key technical documentation, excluding clinical trial results, for FDA evaluation. The agency assessed major nonclinical and quality data, including biocompatibility assessments, animal studies, and sterilization validation. Completing the review allowed the company to confirm that its documentation meets FDA regulatory expectations before filing for marketing approval, reducing uncertainty during the formal review process. NEXT BIOMEDICAL plans to complete its ongoing U.S. clinical trial as scheduled and then submit a final marketing application with clinical data. The randomized controlled study compares genicular artery embolization (GAE) using Nexsphere-F with steroid injection therapy for patients with knee osteoarthritis.

Recently, results from a large prospective clinical study conducted at Charité Hospital in Germany were published in Radiology (Impact Factor 17.6). The study reported that GAE with Nexsphere-F reduced pain and improved knee function and quality of life. Numeric Rating Scale (NRS) pain scores decreased from 7 pre-treatment to 3 at 12-month follow-up, with no serious procedure-related adverse events. The company indicated these findings will support its U.S. regulatory submission.

NexEos Bio’s IND clearance for NTX-1024 follows positive results from an open-label, investigator-initiated study in Mexico. That study enrolled 15 patients with mild to moderate VKC who received NTX-1024 eye drops four times daily for four weeks. 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, and was safe and well-tolerated. The planned Phase II/III trial is a single, randomized, double-masked, vehicle-controlled study to evaluate safety and efficacy of NTX-1024 ophthalmic solution in VKC patients.

In addition, on January 16, 2026, the FDA granted Orphan Drug Designation to NTX-1024 for VKC. The company’s CEO stated that clearance of the IND is an important step for the program and that they plan to initiate the Phase II/III trial by the second half of this year. NTX-1024 is designed to neutralize eosinophil cationic protein to reduce inflammation in rare forms of allergic conjunctivitis. VKC is a rare, chronic, vision-threatening eosinophil-driven condition that can cause permanent vision loss if untreated.