IVIEW Therapeutics Announces FDA Clearance of IND for IVW-1001, a First-in-Class TRPM8 Agonist for Dry Eye Disease

Mar 09, 2024 08:27 CST Updated 08:27

iView Therapeutics

Ophthalmic Innovative Drug Developer

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On March 8, iView Therapeutics announced that the FDA had approved the company's Class 1 new drug IVW-1001 for treatment.Dry EyeClinical IND Application. This trial will evaluateA TRPM8 AgonistIVW-1001 inTreatmentSigns and Symptoms of Dry EyeSafety, Tolerability, and Efficacy.iView TherapeuticsExpected to launch a Phase 1/2 clinical trial in the United States in the second quarter of 2024.

iView Therapeutics is an ophthalmic innovative drug research and development company at the clinical development stage. The company is developing small molecule and gene therapy products based on innovative science, novel mechanisms of action, and differentiated drug delivery technology platforms for the treatment of infectious conjunctivitis, dry eye, myopia, presbyopia, glaucoma, and other diseases.

IVW-1001 is a product developed by iView Therapeutics.TRPM8 Receptor Agonist。iView Therapeutics Co-Founder, Chairman and Chief Executive OfficerDr. Liang BoPreviously accepted by the WuXi AppTec content teamInterviewOnce said: "TRPM8 (Transient Receptor Potential M8) is a cold-sensitive receptor that can detect corneal temperature decreases caused by tear evaporation. Enhancing the activity of this receptor can increase baseline tear secretion and the frequency of blinking.Developing agonists for this target can promote tear secretion and rapidly improve the symptoms of dry eye disease.This is different from existing anti-inflammatory, antioxidant products and artificial tears, and also represents an innovative mechanism for treating dry eye syndrome."

▲WuXi AppTec Content TeamExclusive InterviewDr. Liang Bo

According to the public data from iView Therapeutics, the Proof of Concept (POC) clinical trial results show that IVW-1001 takes effect within one week of administration, rapidly promoting tear secretion from the lacrimal glands, thereby directly treating the symptoms and significantly improving patient conditions.

Chief Medical Advisor Responsible for the Clinical Development of IVW-1001 ProjectDr. Houman HemmatiDry eye is a condition that affects millions of people worldwide, and TRPM8 agonists represent an innovative approach to treating dry eye disease. We look forward to the possibility of advancing innovative products in this important field.

Co-founder, Chairman and CEO of iView TherapeuticsDr. Liang BoWe are delighted that the FDA has approved our clinical IND application on time to initiate the clinical development of this novel compound.Novel Mechanism of TRPM8 AgonistsAndInnovative Drug Delivery Method via Eyelid Wipes, which can simultaneously treat the symptoms and signs of dry eye disease, providing a potentially differentiated product for the global treatment of dry eye disease. We will conduct the first-in-human (FIH) clinical Phase 1/2 trial directly in patients with dry eye disease in the second quarter of 2024."

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