IVIEW Therapeutics Announces Positive Phase 2 Topline Results for IVIEW-1201 in Acute Bacterial Conjunctivitis

Nov 11, 2023 08:28 CST Updated 08:28

iView Therapeutics

Ophthalmic Innovative Drug Developer

▎WuXi AppTec Content Team Report

On November 9, IVIEW Therapeutics (US) and iView Therapeutics, Inc. (Zhuhai) (hereinafter referred to as "iView Therapeutics") launched their innovative drug globally for the first time.IVIEW-1201 (1.0% Povidone-Iodine Ophthalmic Gel Sterile Solution)Conducted in ChinaPhase 2 Clinical Trial of Acute Bacterial ConjunctivitisPositive Top-Line Clinical Trial Results.

The positive results announced this time are fromOneA multicenter, randomized, parallel-group, Phase 2 clinical trial with levofloxacin eye drops as the positive control,EvaluationIVIEW-1201Efficacy and Safety of Treating Acute Bacterial Conjunctivitis. The trial has been approved by both the U.S. FDA and China NMPA, and was launched in December 2022.The group leader unit is the Affiliated Eye Hospital of Shandong First Medical University. The principal investigator of the trial isProfessor Shi Wei YunAndProfessor Wang Ting, conducted at 12 research centers in China, with a total of 129 subjects enrolled.

The StudyReached the pre-set primary endpoint: The clinical cure rate was the same between the experimental group and the positive control group, but the clinical cure rate of the experimental group showed a trend of being 9.4% higher than that of the control group.。Based on the central laboratory bacteriological analysis, IVIEW-1201 showed a significant bacterial clearance rate similar to that of the control drug.On the 8±1 day of medication, IVIEW-1201 andControl DrugThe clearance rate for target Gram-positive pathogenic bacteria is the same; the clearance rate for Gram-negative pathogenic bacteria is also the same.In terms of safety,IVIEW-1201 GroupIt has good safety and tolerability, with no drug-related incidents occurring.Serious Adverse Event (SAE)And secondary and aboveAdverse Event (AE). In addition,Although this clinical trial observed ocular adverse events similar to those of comparable drugs, all were mild and transient symptoms of ocular irritation.

Infectious conjunctivitis is a common condition seen in ophthalmology clinics.Multiple diseases,Common diseases, mainly caused by viral or bacterial infections.In clinical practice, the judgment of infectious pathogens is often based on the doctor's clinical experience. Conventional treatment mainly involves antibiotics, either alone or in combination with other drugs.However, due to the difficulty in distinguishing between bacterial and viral infections, there is an urgent need for a broad-spectrum drug capable of eliminating any infectious agents (including viruses and bacteria) in the clinical treatment of conjunctivitis. It is reported that, following the completion of Phase 2 clinical trials in China for treating bacterial conjunctivitis,iView TherapeuticsThe IVIEW-1201 treatment conducted in India and China is expected to be completed by the end of 2023.Viral ConjunctivitisPhase 2 international multicenter clinical trial.

Shandong Provincial Eye HospitalProfessor Wang TingSaid,Consistent with the mechanism of action supported by preclinical evidence,Phase 2 disclosed this timeThe trial demonstratedIVIEW-1201'sProof-of-Concept Clinical Results.Looking forward to discussing with regulatory authorities the initiation of future pivotal Phase 3 clinical trials.

Co-founder, Chairman and Chief Executive Officer of iView TherapeuticsDr. Liang BoCurrently, the FDA has not approved any drugs for the treatment of viral conjunctivitis.IVIEW-1201 is aSustained-Release Povidone-Iodine Eye Drops,Developed by iView Therapeutics' formulation platform technology i-Gel in-situ gel technology。Preclinical data suggest that this productBroad-spectrum antiviral and antibacterial effects, no drug resistance, sustained drug release, and a non-antibiotic innovative eye drop.. The product isClinical development for the two indications of viral conjunctivitis and bacterial conjunctivitis is expected to provide an innovative solution for ocular infectious diseases.Based on the encouraging results of this Phase 2 clinical trial, they will advance IVIEW-1201 to the next stage of development.

▲WuXi AppTec Content TeamExclusive Interview with Liang BoPh.D.

According to Dr. Liang Bo's introduction during a previous interview with the WuXi AppTec content team,The in-situ gel sustained-release technology is a proprietary technology of the company.An innovative delivery platform developed，“It can make the product drop on the ocular surface after,Due to the change in ionic strength of tearsForms a weak gel adhering to the surface of the eyeball, which allows the product to avoid being washed away by tears and thereby achieve a sustained-release effect. Meanwhile, it also has a special property - thixotropy, meaning that the external force from blinking can hydrate the weak gel. This reversible phase change process avoids the blurred vision issue associated with traditional formulations and reduces local irritation to the eye.”

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