IVW-1001 / IVIEW Therap - LARVOL DELTA

Phase 2b Controlled Study of Dosing Techniques - Part B (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: IVIEW Therapeutics Inc. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

Phase 2b Controlled Study (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: IVIEW Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

Phase 2b Controlled Study of Dosing Techniques - Part B (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: IVIEW Therapeutics Inc.

New P2 trial • Dry Eye Disease • Ophthalmology

Phase 2b Controlled Study of Dosing Techniques (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: IVIEW Therapeutics Inc.

New P2 trial • Dry Eye Disease • Ophthalmology

Delivery of TRPM8 Agonists to Ocular Margins for Treatment of Ocular Disorders (ARVO 2025) - "Methods In preclinical studies, New Zealand White rabbits were used to study the ocular and systemic pharmacokinetics (PK) of 0.2% solution of IVW-1001, a novel TRPM8 agonist, using either eyedrops or wiping on the upper eyelid margin with a wipe...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Dry Eye Disease • Ophthalmology • TRPM8

IVIEW Therapeutics Announces Topline Results from Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe for Dry Eye Disease (PRNewswire) - P1/2 | N=150 | NCT06400459 | Sponsor: IVIEW Therapeutics Inc. | "IVW-1001 was well-tolerated across all treatment groups, with the majority of adverse events (AEs) being mild or moderate in severity. Ocular irritation was the most commonly reported AE, observed slightly more frequently in the IVW-1001 treatment groups (3%) compared to vehicle (0%). Importantly, no serious adverse events (SAEs) related to the investigational product (IP) were reported, and no patients discontinued the study due to IP-related AEs...Total Corneal Fluorescein Staining (Zones 1-5): IVW-1001 0.2% reduced staining (-1.7 vs. -1.3 for vehicle, p=0.0097); Eye Dryness Score: IVW-1001 0.2% demonstrated a significant reduction (-22.8 vs. -18.3 for vehicle, p=0.0315); SANDE (Symptom Frequency): IVW-1001 0.2% significantly reduced symptom frequency (-14.4 vs. -9.0 for vehicle, p=0.0017)."

P1/2 data • Dry Eye Disease

IVW-1001-CS-101: IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P1/2 | N=150 | Completed | Sponsor: IVIEW Therapeutics Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Oct 2024 | Trial primary completion date: Jul 2025 ➔ Oct 2024

Trial completion • Trial completion date • Trial primary completion date • Dry Eye Disease • Ophthalmology

IVIEW Therapeutics Inc. Completes Patient Recruitment for Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe in Dry Eye Disease Patients (PRNewswire) - "IVIEW Therapeutics Inc...today announced the completion of patient recruitment for its Phase 1/2 clinical trial evaluating IVW-1001, a novel TRPM8 agonist delivered via ophthalmic eyelid wipe, for the treatment of signs and symptoms of dry eye disease. The company anticipates reporting topline data in the first quarter of 2025."

Enrollment closed • P1/2 data • Dry Eye Disease • Ophthalmology

IVW-1001-CS-101: IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: IVIEW Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dry Eye Disease • Ophthalmology

IVW-1001-CS-101: IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: IVIEW Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Ophthalmology

IVW-1001 Phase 1/2 in Subjects With Dry Eye Disease (clinicaltrials.gov) - P1/2 | N=150 | Not yet recruiting | Sponsor: IVIEW Therapeutics Inc.

New P1/2 trial • Dry Eye Disease • Ophthalmology

Nonclinical Development of a Novel Therapeutic Ophthalmic Eyelid Wipe to Treat Dry Eye Disease (ARVO 2024) - "Efficacy, ocular PK and toxicity studies of IVW-1001 OEW and OS demonstrated effective and safe ocular target concentrations when applied to the eyelid and/or ocular surface in rabbits and/or minipigs, which supported the Phase 1/2a clinical trial of ≤ 0.2% IVW-1001 OEW BID in DED patients."

Dry Eye Disease • Ophthalmology • TRPM8