iView Therapeutics Launches IVW-1001-CS-202 Clinical Trial for Dry Eye Disease

iView Therapeutics recently announced the official launch of the IVW-1001-CS-202 clinical trial and held a kick-off meeting.IVW-1001 is a novel TRPM8 agonist delivered via eyelid wipes, intended for the treatment of dry eye disease.。

Dr. Kenneth Sall, Medical Monitor at iView Therapeutics and senior ophthalmologist, shared his insights on the scientific rigor of the trial and endpoint strategy. He emphasized the importance of reducing variability in testing, particularly regarding the Schirmer Tear Test, which is central to assessing the efficacy of IVW-1001. This test is inherently susceptible to variability due to factors such as patient characteristics, environmental conditions, and procedural techniques. Therefore, ensuring standardized execution and strict oversight is crucial for obtaining reliable and reproducible results.

Dr. Sall pointed out, "We now need to determine the optimal time to measure peak efficacy… Is it at 3 minutes, 5 minutes, or 10 minutes when the effect is the strongest? Currently, the time to reach peak efficacy for the study drug has not been established, and a deeper understanding of the time required to achieve peak efficacy is one of the key focuses of this research." He further emphasized that minimizing variability in endpoint assessments is crucial to obtaining robust and interpretable study results.

In addition, he emphasized that objective indicators (such as tear secretion volume and corneal staining) should be combined with patient subjective feedback (such as SANDE scores and ODS scores). "Our goal is to develop a product that not only improves the condition of the disease but also makes patients feel better," he said.

In terms of safety, Dr. Sall introduced a comprehensive monitoring plan, focusing on adverse events and eye examinations, and emphasized the importance of maintaining open communication between the research centers and the sponsor team: "The key is to keep communication open. Research centers should feel completely at ease contacting us."

As IVW-1001-CS-202 moves into the clinical implementation and participant recruitment phase, Dr. Sall and Ms. Stewart both emphasized the importance of collaboration, stability, and high responsiveness. With a solid operational framework, experienced research center partners, and a shared commitment to scientific rigor, the team is expected to generate high-quality data to advance this promising new therapy for the benefit of patients with dry eye disease.

IVIEW Therapeutics is a clinical-stage ophthalmic innovative drug development company. iView Therapeutics (Hengqin, Zhuhai) Co., Ltd. is the wholly-owned subsidiary of IVIEW Therapeutics in China. The company is committed to developing clinically differentiated products to address unmet medical needs. Focusing on innovative science, novel mechanisms of action, and differentiated drug delivery technology platforms, the company develops a pipeline of products with potential commercial advantages. Its innovative portfolio of small molecules and gene therapies covers disease areas such as infectious conjunctivitis, dry eye syndrome, myopia, presbyopia, and glaucoma.

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