IVIEW Therapeutics (“IVIEW”) today announced that its investigational ophthalmic drug, IVIEW-1201D, has received U.S. Food and Drug Administration (FDA) Phase III IND clearance for the treatment of adenoviral conjunctivitis. This important milestone marks the program’s entry into a new phase of global, pivotal clinical development and represents a major step toward addressing a long-standing unmet medical need.
Addressing an Unmet Need: Innovative Therapy Targeting a Global Treatment Gap
The global market for ocular infection therapeutics was approximately $8.1 billion in 2025 and is expected to grow to $11.9 billion by 2035, representing a compound annual growth rate (CAGR) of 3.9%. The global acute conjunctivitis market reached $4.2 billion in 2024 and is projected to exceed $6 billion by 2031, driven by rising disease awareness and therapeutic innovation, particularly in viral conjunctivitis.
Acute conjunctivitis (“pink eye”) remains one of the most common infectious ocular diseases worldwide, across major global regions, including the U.S., Japan, and Europe. Among infectious cases, approximately 80% are viral, and 65–90% of those are caused by various adenovirus serotypes. The condition is highly contagious, leading to productivity loss, unnecessary healthcare utilization, and frequent misuse of antibiotics. Beyond direct viral injury, the body’s immune response can damage ocular surface tissues, leading to secondary inflammatory injury that is often irreversible.
Currently, no FDA-approved treatments exist for viral conjunctivitis, including adenoviral conjunctivitis.
IVIEW’s candidate IVIEW-1201D builds upon the company’s prior development of IVIEW-1201, which contains low-concentration povidone-iodine (PVP-I) (a broad-spectrum antimicrobial that also exhibits antiviral activity).
To advance the therapeutic potential of this approach, IVIEW has developed IVIEW-1201D, a formulation combining low-dose PVP-I with difluprednate (DFBA), a potent corticosteroid with superior receptor affinity and ocular penetration compared with dexamethasone. The combination aims to leverage PVP-I’s broad antiviral and antimicrobial activity together with DFBA’s strong anti-inflammatory properties, offering a comprehensive therapy for adenoviral conjunctivitis. If successful, IVIEW-1201D could become the first broad-spectrum treatment for this highly prevalent viral eye disease.
Phase III Clinical Program: A Global, Multicenter Pivotal Study
With the FDA’s allowance to proceed, IVIEW will initiate a global Phase III clinical trial enrolling approximately 500 patients with viral conjunctivitis across multiple countries and regions. The study will evaluate the efficacy and safety of the IVIEW-1201D suspension compared with the IVIEW-1201 PVP-I solution and placebo.
Advancing Our Mission
“From the earliest discovery formulation studies in the lab to our dual U.S.–China clinical development efforts and now the FDA’s Phase III IND allowance, we have remained committed to our mission of bringing a broad-spectrum treatment to ocular infection worldwide,” said Bo Liang, PhD, MBA, Co-Founder, Chairman, and Chief Executive Officer, IVIEW Therapeutics. “There are currently no FDA-approved treatments for adenoviral conjunctivitis. We look forward to advancing this study and patients with a much-needed therapeutic option.”
About IVIEW Therapeutics Inc.
IVIEW Therapeutics Inc. is a clinical-stage biotechnology delivery platform to create therapies with superior clinical profiles that address significant unmet medical needs. Our pipeline includes small molecules and gene therapies for dry eye, myopia, conjunctivitis, glaucoma, and presbyopia. The U.S. headquarters is in Cranbury, New Jersey, with 11,045 square feet of combined laboratory and office space in the Princeton area.
For additional information, please visit www.iviewtherapeutics.com
Media Contact:
Wei Wang, PhD; VP of Translational Research and Head of Operations
Email: weiwang@iviewinc.com