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Novaliq GmbH has reported positive phase I results with its clear cyclosporin solution eye drop formulation (CyclASol) in clinical development for patients with dry eye syndrome.
Heidelberg, Germany-Novaliq GmbH has reported positive phase I results with its clear cyclosporin solution eye drop formulation (CyclASol) in clinical development for patients with dry eye syndrome.
The objectives of the 18-patient, double-blind, randomized, placebo-controlled cross-over study were to investigate safety, local tolerability and systemic exposure of the eye drops and vehicle following single and multiple ocular doses in healthy volunteers.
No drug-related signs or symptoms of ocular discomfort or irritation were reported, as were 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 4 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.
“For patients with dry eye disease, there are few approved drug options available,” said Dieter Scherer, PhD, Novaliq’s chief scientific officer. “Cyclosporin is a well accepted active drug substance for this disease, although current formulations come with several limitations, including side effects and limited patient acceptance due to cyclosporin’s poor solubility.”
“We are very pleased by the study results, since they clearly show that our innovative clear solution formulation of cyclosporin using our EyeSol platform technology is safe and convenient for patients,” added Bernhard Guenther, president and chief executive officer of Novaliq. “We have a granted patent position in most relevant markets and look forward to continuing our clinical development trials in dry eye disease either on our own or with interested partners.”
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