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CyclASol Phase 1 study finds positive results from repeated and ascending dose

Article

Novaliq GmbH recently reported positive Phase 1 results with its cyclosporin solution eye drop formulation in clinical development for patients with dry eye.

Heidelberg, Germany-Novaliq GmbH recently reported positive Phase 1 results with its cyclosporin solution eye drop formulation in clinical development for patients with dry eye.

According to the company, the objectives of the 18-patient, double-blind, randomized, placebo-controlled, cross-over study were to investigate safety, local tolerability, and systemic exposure of CyclASol (cyclosporin solution) eye drops and vehicle following single and multiple ocular doses in healthy volunteers.

Creating a dry eye protocol

No drug-related signs or symptoms of ocular discomfort or irritation were reported-in particular, no dryness, grittiness, burning, stinging, tiredness, blurred or foggy vision, redness, watery eyes, eye mucus, or crusting. In slit-lamp examinations, no subjects revealed any clinically abnormal signs of the anterior and posterior eye structures. With dosing of up to four drops per eye per day, no systemic levels of cyclosporin were detected after any dose or at any time point when using a highly sensitive assay with a LLOQ as low as 0.1 ng/ml.

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