Health Canada Issues “No Objection Letter” for Clinical Trial Application Evaluating Povidone Iodine-Budesonide Gel Forming Suspension in Patients Undergoing Endoscopic Sinus Surgery
2025-10-13 · IVIEW Therapeutics Inc. · original iviewtherapeutics.com ↗
[Cranbury, New Jersey – October 13, 2025] – IVIEW Therapeutics today announced that Health Canada has issued a No Objection Letter (NOL) for the proposed clinical trial titled “Evaluation of Povidone Iodine (PVP-I) + Budesonide Gel Forming Suspension Following Endoscopic Sinus Surgery (ESS).” The letter was addressed to Principal Investigator Dr. Amin Javer at St. Paul’s Hospital, Vancouver, British Columbia, confirming that Health Canada has completed its review of the clinical trial application (Control Number 300965) and has no objection to the study proceeding. Endoscopic sinus surgery (ESS) is a common otolaryngologic procedure used to treat patients with chronic rhinosinusitis (CRS) who fail to respond to medical therapy. While most patients recover well, approximately 15–20% continue to experience persistent sinus symptoms. Bacterial biofilms within the sinus cavities are a major factor contributing to treatment resistance and symptom recurrence, yet there are currently no standardized treatments to effectively eradicate them. Povidone iodine (PVP-I), a well-established antiseptic, has demonstrated strong antimicrobial and antiviral properties, including the ability to disrupt bacterial biofilms in vitro. When combined with budesonide, a corticosteroid with potent anti-inflammatory effects, this fixed combination formulation IVIEW-1502 (0.8%PVP-I/0.02% Budesonide gel forming suspension) aims to provide both antimicrobial and anti-inflammatory benefits within the postoperative sinus cavity through nasal irrigation with a drug pre-loaded syringe. The primary objective of this clinical study is to determine whether the intra-sinus application of PVP-I + budesonide gel immediately following ESS leads to a reduction in the endoscopic MLK score at 12 weeks post-operation compared with vehicle control. “We are pleased to receive Health Canada’s No Objection Letter for this important clinical investigation,” said Amin Javer, MD, FRCSC, FARS, Director, St. Paul’s Sinus Centre. “This study represents a significant milestone in our mission to advance innovative, locally delivered therapies that address unmet medical needs in chronic rhinosinusitis and related inflammatory airway diseases.” The study will be conducted at St. Paul’s Hospital in Vancouver, British Columbia, under the supervision of Dr. Amin Javer’s team, who specialize in rhinology and sinus disease treatment. About St. Paul’s Hospital and Principal Investigator: Dr. Amin Javer St. Paul's Hospital is an acute care hospital located in downtown Vancouver, British Columbia, Canada. It is the oldest of the 18 health care facilities operated by Providence Health Care, a Roman Catholic faith-based care provider. Dr. Amin Javer is a currently a clinical professor in the department of surgery at the University of British Columbia (UBC), the director of rhinologic and fellowship training at UBC, co-director of research in the division of Otolaryngology at UBC, and director of the St. Paul’s Sinus Centre. Dr. Javer specializes in otolaryngology, with a focus on advanced rhinology, sinus, and skull base surgery. About IVIEW Therapeutics IVIEW Therapeutics Inc. is a clinical-stage biotechnology company focused on developing innovative ophthalmic therapies. We invest in novel mechanisms of action and differentiated drug delivery platforms to create therapies with superior clinical profiles that address significant unmet medical needs. Our pipeline includes small molecules and gene therapies for dry eye, myopia, conjunctivitis, glaucoma, and presbyopia. The U.S. headquarters is in Cranbury, New Jersey, with 11,045 square feet of combined laboratory and office space in the Princeton area. IVIEW Therapeutics has developed novel drug delivery solutions for ocular and upper-airway inflammatory diseases. The company’s proprietary in-situ gel-forming technology enables targeted, sustained, and patient-friendly delivery of therapeutics for local treatment of mucosal inflammatory disorders. Forward-Looking Statement This press release contains forward-looking statements, including statements regarding the expected progression, scope, and impact of clinical studies and product candidates. These statements are based on current expectations and assumptions that are subject to risks and uncertainties, which could cause actual outcomes to differ materially. IVIEW Therapeutics undertakes no obligation to update or revise any forward-looking statements except as required by law. For additional information, please visit www.iviewtherapeutics.com Media Contact: Email: [email protected]
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