IVIEW announces Completion of First Patient Treatment in Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis
2023-01-18 · IVIEW Therapeutics Inc. · original iviewtherapeutics.com ↗
January 18, 2023 Cranbury, New Jersey, USA: IVIEW Therapeutics Inc. announced today that the first 2 patients completed treatment on the multi-center, randomized, parallel, positive control with Ofloxacin Phase II Clinical Trial by lead principal investigators Drs. Weiyun Shi and Ting Wang at the Eye Hospital of Shandong First Medical University. This clinical trial has currently initiated 12 sites across China with enrollment of first patient on January 5th, 2023. Two patients have completed the treatment and finished all follow-up visits. The successful dosing of 2 patients in the trial encouraged the clinical development team to complete the clinical trial on time in 2023 across the country with high standards. Expert ophthalmologists in the eye hospital commented “Infectious conjunctivitis is a common and frequently occurring disease in ophthalmic clinics, and it mainly caused by viral or bacterial infections. At present, the conventional treatment is based on antibiotics or combination with other drugs. However, it is difficult to distinguish between bacterial and viral infections, there is an unmet clinical need for a drug that can treat any source of infections, such as viruses and bacteria, to treat the common acute conjunctivitis (“pink eye”)”. IVIEW-1201 is a sustained-release povidone-iodine gel-forming sterile ophthalmic solution developed with iVIEW’s proprietary i-Gelin-situ gel technology, a novel patented platform technology at IVIEW Therapeutics Inc. The active ingredient of this product, povidone iodine, gradually releases free iodine. The mechanism of action for its powerful antiseptic effect is for free iodine to oxidize the protoplasmic protein and denature it. This allows iodine to effectively kill viruses, bacteria, fungi and other pathogens in a rapid fashion with minimal drug resistance developing from repeated administrations. When IVIEW-1201 is instilled into the eye, sol-to-gel forms a weak in-situ gel on ocular surface due to ion strength increase in the tears. The in-situ gel forming mechanism makes drug retention on ocular surface much longer than traditional eye drops to avoid rapid drainage thus to achieve sustained release. Interestingly, the i-Gel in-situ gel system has a special thixotropy i.e. the external disturbance caused by eye blinking can turn the weak gel into a flowing liquid. This reversible sol-to-gel process not only minimized blurred vision in traditional gel dosage forms but also reduces local eye irritation after eye drop instillation. In addition to the Phase II clinical trial of IVIEW-1201 for the treatment of bacterial conjunctivitis in China, multi-center phase II trials of IVIEW-1201 for the treatment of viral conjunctivitis is currently underway in both India and China. The company previously conducted an exploratory phase II clinical study of 44 patients to treat viral conjunctivitis in India and demonstrated the safety and tolerability of IVIEW-1201 in viral conjunctivitis patients. Ms. Qingchun Song, President of Proswell Medical, a Beijing based leading CRO organization with extensive ophthalmology clinical research experience commented; “If this drug is marketed, it will significantly change the treatment choices of bacterial conjunctivitis which now can only be treated with antibiotics with drug resistance prevalence. While facing Covid-19 pandemics and strict pandemic control policies, which led to the low incidence of bacterial conjunctivitis, we overcame various challenges and supported the sponsor and researchers to quickly complete the enrollment of the first patient. We will continue to recruit patients quickly and conduct the trial with high quality, and we hope this drug can be launched as soon as possible." Dr. Bo Liang, Co-founder, Chairman and CEO of iVIEW Therapeutics Inc. commented; “Currently, FDA has not approved any drug for the treatment of viral conjunctivitis. IVIEW-1201 is a broad-spectrum non-antibiotic innovative eye drop, which can potentially treat both viral and bacterial conjunctivitis without potential drug resistance. If IVIEW-1201 is successfully developed to treat viral conjunctivitis and bacterial conjunctivitis, it will provide an innovative and ideal solution for eye infections and fill up the significant unmet medical need that many multinational pharmaceutical companies including numerous biotechnology companies have been working hard for years and failed." In the mean time, Dr. Liang expressed his gratitude to the Eye Hospital of Shandong First Medical University, Proswell Medical and all colleagues and researchers involving in the trial. It is expected that 2023 will be a prosperous year, and patients will be enrolled as soon as possible to complete the Phase II clinical trials with high quality and standards. About iVIEW Therapeutics Inc. iVIEW Therapeutics Inc. is a clinical stage biotechnology company focusing on innovative ophthalmic therapeutics.. We are driven by the pursuit of innovative science that leads to differentiated products to fulfill unmet medical needs. We invest in novel mechanisms of action, and differentiated drug delivery technology platforms that allow us to bring forward assets with potentially superior target product profiles. The company's innovative eye drugs cover dry eye, myopia, conjunctivitis, presbyopia, and innovative gene therapy.The U.S. headquarters is located in Cranbury, Princeton, New Jersey with 11,045 sq. fts. Laboratory and office space in the Princeton area. The company adheres to the vision: Bright Science, Clear Vision! For details, please refer to the company websites: www.iVIEWtherapeutics.com
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