IVIEW Therapeutics Inc. ("IVIEW"), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative ophthalmic therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 3 clinical trial for IVIEW-1701. IVIEW-1701 is an innovative drug candidate designed for the treatment of inflammation following cataract surgery, marking a critical step toward global commercialization.
Cataract surgery is one of the most common and routine ophthalmic surgical procedures worldwide. Success depends not only on surgical precision and advanced equipment but also on the effective management of post-operative inflammation. Proper anti-inflammatory treatment is essential for visual recovery, accelerating the healing process, and reducing the risk of complications, thereby ensuring long-term surgical stability and patient comfort.
IVIEW-1701 is a preservative-free, single-dose innovative eye drop containing a potent corticosteroid. It was developed using IVIEW's proprietary nanomicelle technology platform and in-situ gel delivery technology. These platforms significantly enhance the drug's ocular retention time and corneal penetration. Non-clinical studies have demonstrated that IVIEW-1701 possesses an excellent safety and efficacy profile.
The newly cleared Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of IVIEW-1701 in patients following cataract surgery.
"Receiving FDA clearance for the Phase 3 trial of IVIEW-1701 is a significant milestone in our company's mission to innovate ophthalmic surgery," said Dr. Bo Liang, CEO and Founder of IVIEW Therapeutics Inc. "There remains a substantial unmet need in the market for post-cataract inflammation management. Physicians and patients alike are seeking more efficient and convenient treatment options. We believe that with its differentiated technology, IVIEW-1701 has the potential to become a Best-in-class therapy in this field."
According to market analysis, the global market for anti-inflammatory drugs following cataract surgery continues to grow. Upon successful launch, IVIEW-1701 will further enrich IVIEW's product pipeline in the anterior segment disease space and solidify the company's leadership in innovative ophthalmic R&D.
About IVIEW Therapeutics Inc.
IVIEW Therapeutics Inc. is a clinical-stage biotechnology company focused on developing innovative ophthalmic therapies. We invest in novel mechanisms of action and differentiated drug delivery platforms 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