IVIEW’s IVW-1001-CS-202 Trial Kicks Off with Strong Clinical Leadership and Strategic Oversight
2025-07-28 · IVIEW Therapeutics Inc. · original iviewtherapeutics.com ↗
[Cranbury, New Jersey, USA, July 28, 2025] — iView Therapeutics officially launched its IVW-1001-CS-202 clinical trial with a kickoff meeting that brought together key leaders from its clinical team and contracted CRO, PRN Pharmaceutical Research Network. The meeting highlighted the trial’s strategic direction and operational readiness. Dr. Kenneth Sall, a seasoned ophthalmologist and iView’s Medical Monitor, shared his perspective on the trial’s scientific rigor and endpoint strategy. With over 100 clinical trials to his credit, Dr. Sall emphasized the importance of reducing variability in testing, particularly with the Schirmer Tear Test which is central to evaluating IVW-1001’s efficacy. The Schirmer Tear Test is known to have inherent variability due to factors such as patient characteristics, environmental conditions, as well as technique-related inconsistencies. Proper administration and oversight are therefore essential to ensure reliable and reproducible results. Dr. Sall noted, “We now need to determine what is the best time to measure peak efficacy… does it work best at 3 minutes, 5 minutes, 10 minutes? At this stage, the peak efficacy time point for the study drug remains undetermined, and expanding our understanding of the time to peak efficacy is a key focus of the ongoing investigation.” He further stressed that minimizing variability in endpoint assessment is critical to achieving robust and interpretable trial outcomes. He also stressed the importance of combining objectivesigns like tear production and corneal staining with patient-reported outcomes such as SANDE and ODS scores. “We want to drive a productthat makes the condition better and the patient feel better,” he noted. On the safety front, Dr. Sall outlined a robust monitoring plan, focusing on adverse events and ocular assessments. He emphasized the importance of clear communication between sites and the sponsor team: “The answer is open communications. The site should feel comfortable reaching out.” Jeanette Stewart, iView’s Clinical Operations Director, described the operational framework supporting the trial. PRN successfully executed the first- in-human IVW-1001-CS-101 trial, is again leading the clinical execution for CS-202. “PRN has a complete team of professionals managing clinical operations. The team reports to me weekly in my role as iView’s Clinical Operations Director,” Ms. Stewart explained. To ensure accurate protocol execution, PRN conducted a formal Site Initiation Visit led by its Senior CRA and Medical Monitor. Ms. Stewart also highlighted PRN’s proprietary processes and the experience of the selected site: “We have great confidence in their abilityto execute the trial correctly. Our Senior CRA willvisit frequently, and a SeniorPM [Project Manager] is overseeing the project team." As IVW-1001-CS-202 progresses into clinical activity and enrollment, both Dr. Sall and Ms. Stewart emphasized the importance of collaboration, consistency, and responsiveness. With a strong operational framework, experienced site partners, and a shared commitment to scientific rigor, the team is well-positioned to generate high- quality data and advance a promising new treatment for patients living with dry eye disease. About IVIEW Therapeutics Inc. 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 located in Cranbury, New Jersey, with 11,045 square feet of combined laboratory and office space in the Princeton area. For additional information, please visit www.iviewtherapeutics.com Media Contact: Email: [email protected]
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