IVIEW Therapeutics Announces Topline Results from Phase 1/2 Trial of IVW-1001 Ophthalmic Eyelid Wipe for Dry Eye Disease

CRANBURY, N.J., Feb. 10, 2025 /PRNewswire/ -- IVIEW Therapeutics Inc., a clinical-stage biotechnology company dedicated to advancing innovative treatments for ocular diseases, today announced positive topline data from its Phase 1/2 clinical trial evaluating 2 concentrations of IVW-1001, a novel TRPM8 agonist delivered via an ophthalmic eyelid wipe, for the treatment of dry eye disease. The trial enrolled 150 patients in 10 sites in the United States (NCT06400459).

Given the novel compound and novel delivery method, the purpose of the trial was to assess tolerability/safety, determine appropriate dose, and identify potential efficacy endpoints for future trials.

Safety Results Confirm Favorable Tolerability Profile
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. These findings reinforce the safety of IVW-1001 and its suitability for further clinical development.

Preliminary Efficacy Results Identify Potential Endpoints For Future Trials

The trial achieved statistically significant and clinically meaningful improvements in key signs and symptoms of dry eye patients at the final timepoint (Week 4), including reductions in corneal fluorescein staining (total and inferior zones) and significant reductions in symptom scores, including Eye Dryness Score and SANDE (frequency and severity). There were also positive trends in both basal (anesthetized) and reflex (unanesthetized) tear production. Moreover, the data demonstrated a dose-response relationship, with the higher dose (0.2%) consistently showing greater efficacy across multiple endpoints.

Key Data Highlights at Week 4:

• 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)

Advancing Toward Larger Pivotal Trials

"We are thrilled to have reached this key milestone in our clinical development program for IVW-1001," said Houman Hemmati, MD, PhD, Board Director, Chief Medical Advisor at IVIEW Therapeutics Inc. "The data from this Phase 1/2 trial underscore the potential of IVW-1001 to address both the signs and symptoms of dry eye disease. These results provide a strong foundation for advancing into pivotal trials with confidence, further exploring IVW-1001's efficacy and safety in a larger patient population."

A Step Forward in Innovative Ophthalmic Treatments

Bo Liang, PhD, MBA, Co-founder, Chairman, and CEO of IVIEW Therapeutics Inc., commented, "Both the statistically significant and clinically meaningful improvements observed across both signs and symptoms reaffirm the potential of our TRPM8 agonist program to address the unmet needs of patients with dry eye disease. IVW-1001's novel mechanism of action and unique delivery via an ophthalmic eyelid wipe offer a differentiated approach to treatment. We are committed to advancing this program rapidly to bring a new, effective therapeutic option to patients worldwide."

About IVIEW Therapeutics Inc.

IVIEW Therapeutics Inc. is a clinical-stage biotechnology company focusing on innovative ophthalmic therapeutics. Driven by the pursuit of cutting-edge science, we aim to develop differentiated products that fulfill unmet medical needs. We invest in novel mechanisms of action and advanced drug delivery technology platforms to bring forward assets with potentially superior target product profiles. Our innovative portfolio of small molecules and gene therapy assets covers dry eye, myopia, conjunctivitis, glaucoma, and presbyopia.

Located in Cranbury, New Jersey, IVIEW operates a state-of-the-art 11,045 sq. ft. laboratory and office space in the Princeton area. For additional information, please visit our website at  www.iviewtherapeutics.com. For further inquiries or media contacts, please reach out to our team at  [email protected].

SOURCE IVIEW Therapeutics Inc.