iView Therapeutics completes enrollment in phase 1/2 trial for ophthalmic eyelid wipe for the treatment of dry eye disease

(Image Credit: AdobeStock/Kabardins photo)

iView Therapeutics Inc has completed patient recruitment for its Phase 1/2 clinical trial (NCT06400459) evaluating IVW-1001 for the signs and symptoms of dry eye disease (DED).

The Phase 1/2 trial will be a randomized (1:1:1), multicenter, parallel, vehicle-controlled, double-masked study to evaluate the safety, tolerability, and efficacy of IVW-1001. Treatments will be IVW-1001 Ophthalmic Eyelid Wipe 0.2% (high dose), IVW 1001 0.1% (low dose), or IVW-1001 Ophthalmic Eyelid Wipe Placebo (vehicle).²

IVW-1001 is a novel TRPM8 agonist delivered via ophthalmic eyelid wipe, being developed to treat DED.^1,2 IVW-1001 is intended to increase tear secretion and improve pain symptoms by acting on the TRPM8, or transient receptor potential cation channel subfamily M member 8. TRPM8 is a member of the melastatin-related TRP channel subfamily and is expressed on sensory neurons in the cornea and eyelid.³

Earlier in March of 2024, the US Food and Drug Administration (FDA) cleared iView’s Investigational New Drug (IND) application for the initiation of the Phase 1/2 clinical trial.

IVW-1001 has previously shown a short duration of action and improvement in key signs and symptom relief in an Investigator Sponsored Clinical Trial. It was able to increase tear production within 5-20 minutes of administration and longer lasting effects after 2 weeks of administration. This benefit was not accompanied by any adverse events.⁴

Bo Liang, PhD, MBA, co-founder, chairman, and CEO of iView Therapeutics Inc. commented on the recruitment in a press release from the company: "The completion of patient recruitment ahead of schedule is a testament to the dedication of our clinical team and the interest from the ophthalmic community. IVW-1001's novel mechanism of TRPM8 activation and its innovative delivery through an ophthalmic eyelid wipe could offer a differentiated treatment for dry eye disease worldwide. We look forward to sharing our findings as soon as they are available."

iView Therapeutics anticipates reporting topline data from the trial in the first quarter of 2025.

References:

1. IVIEW Therapeutics Inc. Completes Patient Recruitment for Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe in Dry Eye Disease Patients. Press Release; September 17, 2024. Accessed September 18, 2024. https://www.prnewswire.com/news-releases/iview-therapeutics-inc-completes-patient-recruitment-for-phase-12-trial-of-ivw-1001-ophthalmic-eyelid-wipe-in-dry-eye-disease-patients-302250696.html

2. IVW-1001 Phase 1/​2 in Subjects With Dry Eye Disease. NCT06400459. https://clinicaltrials.gov/study/NCT06400459

3. A Novel TRPM8 Agonist for the Treatment of Dry Eye Disease. Protheragen Inc. https://www.protheragen.com/pdf-down/a-novel-trpm8-agonist-for-the-treatment-of-dry-eye-disease/

4. Dry Eye. iView Therapeutics. Accessed September 18, 2024. https://www.iviewtherapeutics.com/researchAndDevelopment/IVW-1001