An In-situ Gel-forming Solution for the Treatment of Conjunctivitis

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1.0% Povidone-iodine Ophthalmic Solution

IVIEW-1201 is a broad-spectrum non-antibiotic ophthalmic topical formulation developed based on a novel proprietary in-situ gel technology. In-situ gel technology is a promising drug delivery strategy that undergoes a ‘sol to gel’ transition upon administration, providing controlled and prolonged drug release. Before administration into the ocular surface, IVIEW-1201 is in solution form, and after administration, gelation can be triggered by the increase of cationic strength in tears. In addition, because of the thixotropic property of gel, the external force generated by blinking can cause the hydration of the weak gel, reducing local irritation to eyes. The in-situ gel formulation of IVIEW-1201 offers many remarkable advantages, including increased compliance among patients, prolonged drug residence time at the intended site, less frequent drug administration, lower dose required for treatment, and reduced local side effects.

Conjunctivitis

Conjunctivitis, also known as pink eye, is a common eye disorder that occurs worldwide and affects all ages and social strata. It is caused by a variety of bacteria or viruses and may also be caused by allergies, irritants or medications. Symptoms of conjunctivitis include redness, itchiness, and a discharge in one or both eyes, as well as tearing and sensitivity to light. Most conjunctivitis is self-limiting, but some may progress and cause serious complications. The etiology of most infectious conjunctivitis cases is viral, with 65% to 90% caused by adenoviruses. Viral conjunctivitis is highly infectious and transmissible, causing lost work and school days as well as increased healthcare costs.

Conjunctivitis affects more than 2 percent of the population and imposes economic and social burdens. It is estimated that about 1% of all primary care office visits in the United States are related to conjunctivitis, affecting 6 million people annually. The cost of treating bacterial conjunctivitis alone was estimated to be $377 million to $857 million per year. Only about 30% of primary care patients with conjunctivitis are diagnosed with bacterial infection, but 80% are treated with antibiotics, meaning the risk of antibiotic resistance is increasing.

Releasing Free Iodine to Destroy Microorganisms

IVIEW-1201 is an in-situ gel-forming povidone iodine (PVP-I) composition with long-lasting antiviral and antimicrobial efficacy. PVP-I is a complex of the potent bactericidal agent iodine with the carrier molecule povidone, which has been used for many years for infection control and prevention. The complex slowly releases free iodine near the cell membrane of target microorganisms, which quickly destroys microorganisms by destabilizing membrane integrity, denaturing nucleic acids, and inhibiting key cellular processes such as electron transport, cellular respiration, and protein synthesis.

PVP-I is used as the active ingredient of IVIEW-1201 due to its broad spectrum of activity and strong effectiveness against gram-positive and gram-negative bacteria, fungi, and viruses. Based on the patented in-situ gel technology, IVIEW-1201 can maintain the effective concentration of PVP-I by the transition between solution and gel forms, thereby achieving long-lasting antiviral and antibacterial effects while reducing irritation.

The Status of IVIEW-1201

IVIEW-1201 is currently undergoing phase II trials for the treatment of adenoviral conjunctivitis in India and China and phase II trials for the treatment of bacterial conjunctivitis in China. Results from an earlier clinical trial in India showed IVIEW-1201 was safe and well tolerated in patients.