IVIEW Therapeutics announces a successful pre-IND meeting with FDA and Received its Full Agreement on Development Plans for IVW-1001, a Novel Treatment for Dry Eye Disease

January 30, 2023 iVIEW Therapeutics Inc., a clinical stage biotechnology company focusing on innovative ophthalmic therapeutics, today announced that the company completed a successful pre-IND meeting with FDA and received the agency’s full agreement on all CMC, non-clinical and clinical development plans to develop IVW-1001 for the treatment of sign and symptoms of dry eye disease (DED). The company is targeting to initiate phase I/II clinical trials for dry eye patients in the end of 2023. Until recently, DED, also known as Dry Eye Syndrome (DES) and keratoconjunctivitis sicca (KCS) has been considered a multifactorial, progressive disorder of the ocular surface resulting from insufficient tear coverage of the cornea and conjunctiva accompanied by ocular surface inflammation. Global dry eye diseases market size is expected to reach US $8.21 billion by 2028 according to Business Wire. Currently available topical therapeutics for DED that target underlying pathophysiology generally do so through anti-inflammatory effects. However, these approaches deliver variable benefits since each drug impacts different steps in the inflammatory cascade, thus with limited fundamental therapeutic value. IVIEW Therapeutics is developing a new chemical entity (NCE), IVW-1001 to treat signs and symptoms of dry eye disease (DED). IVW-1001 is a TRPM8 receptor agonist which selectively activates TRPM8 receptors and their activation has the potential to reduce discomfort. Evidence from clinical studies showed that topical TRPM8 activation reduced eye discomfort and increased tear secretion in those with DED. “This successful Pre-IND meeting is a meaningful milestone for iVIEW that will advance IVW-1001 to the next stage of development” said George Ousler, Senior Vice President for Ora Inc., the premier ophthalmic development firm which aided in this achievement. Dr. Bo Liang, Co-founder, Chairman and CEO of IVIEW Therapeutics Inc. commented; “We are very pleased to have the Agency’s full agreement on our plans to develop this novel compound. This shows confidence in our team and our preclinical and clinical plans to advance IVW-1001 to treat dry eye disease. We are on track for Phase I/II IND filing in 2023 and plan to initiate trials to dose dry eye patients directly in the first-in-human (FIH) clinical trials.” About IVIEW Therapeutics Inc. iVIEW Therapeutics Inc. is a clinical stage biotechnology company focusing on innovative ophthalmic therapeutics. We are driven by the pursuit of innovative science that leads to differentiated products to fulfill unmet medical needs. We invest in novel mechanisms of action, and differentiated drug delivery technology platforms that allow us to bring forward assets with potentially superior target product profiles. The company's innovative portfolio of small molecules and gene therapy assets cover dry eye, myopia, conjunctivitis, glaucoma, and presbyopia. The U.S. headquarters are located in Cranbury, New Jersey near Princeton with 11,045 sq. fts. Laboratory and office space. For additional information, please visit the Company’s website at www.iviewtherapeutics.com.

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