The results of Phase II clinical trial of VVN001, an innovative drug for dry eye disease of Vimbi Biosciences in the United States, are positive

VivaVision, a clinical-stage biotechnology company focusing on ophthalmology, is pleased to announce that its self-developed innovative drug VVN001 has achieved positive results in the US Phase II clinical trial for dry eye disease
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This randomized, double-blind, vehicle-controlled Phase II clinical trial was designed to evaluate the safety and efficacy of VVN001 in patients with moderate to severe dry eye
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A total of 170 patients were enrolled in 14 clinical trial centers in the United States and randomly assigned to VVN001 (5%), VVN001 (1%) and vehicle group
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During the 84-day treatment period, patients received eye drops twice daily and were assessed on days 1, 14, 28, 56, and 84
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The primary efficacy endpoint of this study was improvement from baseline in fluoroscopic staining of the inferior cornea
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After completing the 84-day treatment period, this endpoint demonstrated a favorable treatment effect of VVN001, with the 5% treatment group improving significantly more than the control group
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In total corneal fluorescence staining, compared with the vehicle group, the VVN001 treatment group had obvious clinical significance and statistical significance, and showed a good dose-effect and time-effect relationship
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Similar improvements were seen in Schirmer scores for tear secretion
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In addition, the prespecified clinical secondary endpoint, the Dry Eye Frequency and Severity Score (SANDE), was significantly improved compared to baseline and the control group
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In terms of safety, no significant treatment-related adverse events were observed in the study, indicating that the two dose groups of VVN001 were safe and well tolerated
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Minor irritation at the administration site was the only treatment-related adverse event with an incidence greater than 3%
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It occurred in 3.
5% and 3.
6% of the VVN001-treated and vehicle groups, respectively
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Joseph Tauber, MD, an internationally renowned dry eye treatment expert and Tauber Eye Center in the United States, said: "A large number of patients suffer from dry eye problems, and we urgently need new treatments to help doctors and patients better control dry eye.

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The results of this phase II clinical trial demonstrated that VVN001 had a statistically significant reduction in total cornea and corneal subregional fluorescence staining scores compared to the vehicle group
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"We are very pleased to see that VVN001 significantly improved dry eye symptoms and signs in patients in this first-in-human clinical study," commented Dr.
Joanne Li, Chief Medical Officer of Dimensional Bio.
The positive results of the Phase II clinical trial will strongly support the upcoming Phase III clinical study of Dimensional Bio
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" About VVN001 VVN001 is a brand-new and potent second-generation LFA-1 inhibitor independently developed by Weimou
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In addition to the recently completed Phase II clinical trial in the United States, the Phase I clinical trial drug in healthy volunteers in China has been The kinetic study has also been completed, and the Phase II clinical trial in Chinese patients is underway
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Based on the clinical trial results in the United States, VVN001 (5%) will conduct a pivotal Phase III clinical trial in China and the United States
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Vision Bio is a clinical-stage biotechnology company focusing on the field of ophthalmic treatment.
It has a world-class innovative ophthalmic drug R&D team and technology platform.
Relying on independent research and development, it has established a globally competitive product pipeline, including First-in-Class and Best-in-Class products
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In addition to the VVN001 project, Dimensional Bio will launch a US Phase II clinical trial of VVN539 for the treatment of glaucoma or ocular hypertension this year, and VVN461 for the treatment of non-infectious uveitis.
Phase I clinical trial in China
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