iView Therapeutics Receives FDA Clearance to Initiate Phase 3 Clinical Trial of IVIEW-1201D for Adenoviral Conjunctivitis

On November 13, iView Therapeutics (referred to as "iView Therapeutics") announced today that its self-developed ophthalmic innovative drug IVIEW-1201D has officially received the IND tacit approval from the U.S. FDA, intended for...Initiate the pivotal Phase 3 clinical trial for the treatment of adenoviral conjunctivitis, marking the official entry of the drug into the global pivotal clinical validation stage for the treatment of adenoviral conjunctivitis in the field of ophthalmology.

Acute Conjunctivitis (commonly known as "red eye") is one of the most common infectious eye infections globally, with pathogens including bacteria (both gram-positive and gram-negative), enteroviruses, and most frequently, various adenovirus serotypes. Approximately 80% of infectious conjunctivitis cases are caused by viruses, of which 65%-90% are attributed to adenoviruses. Viral conjunctivitis is highly contagious, not only leading to loss of work and study time but also increasing healthcare costs and posing a risk of unnecessary antibiotic misuse. In addition to the direct damage caused by the infection itself, the body's inherent immune response often excessively attacks the fragile tissues of the eye, resulting in secondary inflammatory damage, which is often irreversible.

iView Therapeutics' self-developed IVIEW-1201DThe main component, povidone-iodine, is a broad-spectrum antibacterial disinfectant that is also effective against viruses.The completed Phase 2 clinical study of IVIEW-1201, developed by the company, has shown that low-concentration (e.g., 1.0%) povidone-iodine ophthalmic preparations can significantly reduce the viral load on the ocular surface and alleviate symptoms. Based on the development foundation of IVIEW-1201, the company has upgraded and iteratively developed IVIEW-1201D.Composed of low-concentration povidone-iodine (PVP-I) and difluprednate (DFBA), used for the treatment of acute conjunctivitis.. This combination product fully leverages the broad-spectrum antibacterial, bactericidal, and antiviral properties of PVP-I, while incorporating the potent anti-inflammatory effects of difluprednate — a corticosteroid that surpasses dexamethasone in receptor binding ability and ocular penetration, offering a promising new treatment option for the broad-spectrum management of adenoviral conjunctivitis.

iView Therapeutics Receives FDA Approval for Phase 3 Clinical Trial of IVIEW-1201D, Which Will Further Validate the Drug's Safety and Efficacy. The Trial Is Planned to Enroll Approximately 500 Patients with Viral Conjunctivitis Across Multiple Countries and Regions Globally, Focusing on Evaluating the Efficacy and Safety of IVIEW-1201D Suspension Compared to IVIEW-1201 PVP-I Solution and Placebo.

References:
[1]iView Therapeutics' Innovative Ophthalmic Drug IVIEW-1201D for Adenoviral Conjunctivitis Receives U.S. FDA Phase III IND Clearance, Entering a New Stage of Global Pivotal Clinical Validation. From https://mp.weixin.qq.com/s/HoSYi8HGxlLE1n3FA5WqQw

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