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On February 10, IVIEW Therapeutics announced itsClass 1 Innovative Drug IVW-1001 for the Treatment of Dry Eye DiseasePositive Topline Data from Phase 1/2 Clinical Trial. The trial evaluated two different concentrations of IVW-1001, which isA Novel TRPM8 Agonist Delivered via Eyelid Wipes for the Treatment of Dry Eye Disease. This trial recruited a total of 150 patients (NCT06400459) across 10 clinical centers in the United States.Given the innovativeness of this novel compound and its delivery method, the primary objectives of this trial are to evaluate its tolerability and safety, determine the appropriate dosage, and identify potential efficacy endpoints for future pivotal clinical trials, in order to bring the new drug to market as soon as possible.
Clinical results confirm good tolerability and safety.IVW-1001 Demonstrates Good Tolerability Across All Treatment Groups, with Most Adverse Events (AEs) Being Mild or Moderate. Ocular Irritation Was the Most Common AE, Occurring at a Slightly Higher Rate in the IVW-1001 Group (3%) Compared to the Control Group (0%). Notably, No Serious Adverse Events (SAEs) Related to the Investigational Product (IP) Were Reported, and No Patients Withdrew from the Study Due to IP-Related AEs. These Results Further Validate the Safety of IVW-1001 and Its Suitability for Future Clinical Development.Preliminary efficacy results identify potential endpoints for future trialsThe test results showed that at the final clinical evaluation time point (Week 4) of this clinical trial,Key signs and symptoms in patients with dry eye disease showed statistically significant and clinically meaningful improvements.Including the reduction of corneal fluorescein staining (overall and inferior zone), as well as a significant decrease in ocular dryness score and SANDE score (frequency and severity). Additionally, both basal tear (anesthetized) and reflex tear (non-anesthetized) secretion showed a positive increasing trend. Moreover, the data also indicated that IVW-1001 demonstrated a clear dose-response relationship, with the higher dose (0.2%) showing better therapeutic effects across multiple efficacy endpoints.Highlights of Key Data for Week 4:- Total Corneal Fluorescein Staining (Regions 1-5): IVW-1001 0.2% group showed reduced staining (-1.7) compared to the control group (-1.3), p=0.0097;
- Ocular Dryness Score:IVW-1001 0.2% group significantly reduced (-22.8), compared to the control group (-18.3), p=0.0315;
- SANDE (Symptom Frequency):IVW-1001 0.2% group significantly reduced (-14.4) compared to the control group (-9.0), p=0.0017
Moving Towards Larger-Scale Pivotal Clinical Trials"We are thrilled to reach this pivotal milestone in the clinical development program of IVW-1001," said Houman Hemmati, M.D., Board Member and Chief Medical Advisor of iVIEW Therapeutics. "The data from this Phase 1/2 clinical trial highlight the potential of IVW-1001 in improving the signs and symptoms of dry eye disease. These results provide a solid foundation as we advance into pivotal clinical trials, allowing us to further explore the efficacy and safety of IVW-1001 in a larger patient population."Another Advance in Ophthalmic Innovative TreatmentsBo Liang, Ph.D., Co-founder, Chairman, and CEO of iVIEW Therapeutics, Inc., stated: "The statistically significant and clinically meaningful improvements observed in this First-in-human (FIH) clinical trial for both signs and symptoms of dry eye disease once again confirm the potential of our TRPM8 agonist program to address unmet needs for patients with dry eye. IVW-1001 has a unique mechanism of action and offers a differentiated treatment approach through an innovative delivery method using eyelid wipes. We are committed to accelerating the progress of this program to bring a new and effective treatment option to patients worldwide as soon as possible."
[1]iVIEW Therapeutics Announces Top-Line Results from Phase I/II Clinical Trial of IVW-1001 Eyelid Wipes for the Treatment of Dry Eye Disease.Retrieved Feb 10, 2025, from https://mp.weixin.qq.com/s/nu0kRDjcnpbUVD7rohbVYgThis article was compiled and edited by the WuXi AppTec content team based on publicly available information. Feel free to share it on your personal social media feed. For authorization to repost or other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
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