IVIEW Therapeutics Releases Phase 1/2 Trial Results for IVW-1001 Eyelid Wipe in Dry Eye Treatment

CRANBURY, N.J., Feb. 10, 2025 - IVIEW Therapeutics Inc., a company committed to developing innovative treatments for eye diseases, has released promising results from its Phase 1/2 clinical trial. This trial focused on evaluating two concentrations of IVW-1001, a new TRPM8 agonist, delivered through an ophthalmic eyelid wipe, aimed at treating dry eye disease. A total of 150 patients across 10 sites in the United States participated in the study (NCT06400459).

The primary goals of the trial were to evaluate the safety and tolerability of the compound, determine the appropriate dosage, and identify potential efficacy endpoints for future research.

The safety profile of IVW-1001 was favorable, with participants experiencing mainly mild or moderate adverse events. The most common adverse event was ocular irritation, slightly more prevalent in the IVW-1001 groups (3%) compared to the placebo group (0%). Importantly, no serious adverse events related to the investigational product were observed, and no participants withdrew from the trial due to such events. These results support the continued clinical development of IVW-1001.

In terms of efficacy, the trial demonstrated statistically significant and clinically meaningful improvements in dry eye symptoms by the end of the study at Week 4. Patients showed reductions in corneal fluorescein staining and improvements in symptom scores such as the Eye Dryness Score and SANDE, which measures symptom frequency and severity. There were also encouraging signs in tear production, both basal and reflex. The trial exhibited a dose-response relationship, with the higher dose of 0.2% yielding greater efficacy across multiple metrics.

Key findings at Week 4 included a significant reduction in total corneal fluorescein staining in the 0.2% IVW-1001 group compared to the vehicle group (-1.7 vs. -1.3, respectively, with a p-value of 0.0097). There was also a noteworthy decrease in the Eye Dryness Score for the higher dose (-22.8 vs. -18.3 for the vehicle, with a p-value of 0.0315) and a significant reduction in the frequency of symptoms as measured by SANDE (-14.4 vs. -9.0 for the vehicle, with a p-value of 0.0017).

Commenting on these findings, Dr. Houman Hemmati, Board Director and Chief Medical Advisor at IVIEW Therapeutics, expressed excitement about reaching this critical milestone. He emphasized that the data highlights IVW-1001's potential to address both signs and symptoms of dry eye disease, paving the way for larger pivotal trials to further investigate its efficacy and safety in a broader patient population.

Dr. Bo Liang, Co-founder, Chairman, and CEO of IVIEW Therapeutics, highlighted the significance of the trial's results. He noted that the improvements across various signs and symptoms indicate the potential of the TRPM8 agonist program to meet the unmet needs of dry eye disease patients. The unique mechanism of action of IVW-1001 and its innovative delivery method offer a distinct treatment approach, and the company is keen to advance this program rapidly to provide an effective therapeutic option to patients globally.

IVIEW Therapeutics Inc. is a biotechnology company at the clinical-stage, focusing on pioneering ophthalmic treatments. The company, based in Cranbury, New Jersey, is dedicated to developing unique products that address unmet medical needs, investing in novel mechanisms of action and advanced drug delivery technologies. Their portfolio includes solutions for dry eye, myopia, conjunctivitis, glaucoma, and presbyopia.