Huons "Combination Eye Drop 'HU007' Receives IND Approval for Dry Eye Syndrome Phase 3 Clinical Trial"

[Asia Economy Reporter Lee Gwan-joo] Huons announced on the 1st that it has received approval from the Ministry of Food and Drug Safety for the domestic Phase 3 clinical trial plan (IND) of the combination eye drop 'HU007' for dry eye syndrome.

Huons had previously applied for product approval after the Phase 3 clinical trial in 2020, but voluntarily withdrew the application in June last year following the Ministry's recommendation to supplement the validity of the statistical processing of the clinical results. Subsequently, in September, Huons applied to the Ministry of Food and Drug Safety for the domestic Phase 3 clinical trial plan of 'HU007' for dry eye syndrome.

HU007 is an eye drop developed to improve dry eye symptoms by combining cyclosporine, an anti-inflammatory ingredient, and trehalose, an ingredient that protects the tear film.

In the clinical trial, the efficacy and safety will be confirmed by comparing HU007 with Allergan's eye drop 'Restasis' in 328 patients with dry eye syndrome. Superiority will also be evaluated compared to Huons' existing eye drop 'Moistview.'

Huons plans to confirm the combined therapeutic effect on dry eye syndrome by lowering the cyclosporine concentration to less than half of existing treatments to minimize ocular surface irritation such as burning sensation, and by combining trehalose formulation to maintain a viscosity suitable for eye drops while reducing moisture evaporation.

A Huons official said, "We will confirm the combined therapeutic effect of HU007 for dry eye syndrome through this clinical trial."

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