CyclASol® (cyclosporin solution formulation in the semi-fluorinated alkane vehicle F4H5) eye drops are safe and well-tolerated
CyclASol® is the first and only clear solution based eye drop formulation in clinical development for patients with dry eye disease
HEIDELBERG, Germany I September 23, 2014 I Novaliq GmbH, a drug delivery company with focus on the topical application of ophthalmic technologies for poorly soluble drugs, today reported positive phase 1 results with the first and only clear cyclosporin solution eye drop formulation in clinical development for patients with dry eye syndrome.
Objectives of the 18 patient phase 1, 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.
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 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. 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 cyclosporins' poor solubility," said Novaliq's Chief Scientific Officer Dieter Scherer, PhD.
"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. 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," added Bernhard Guenther, President & CEO, Novaliq.
"We congratulate Novaliq on their proprietary EyeSol® platform technology, as it continues to deliver on the promise as an innovative safe and well tolerated ophthalmic delivery technology. After NovaTears® OTC, CyclASol® is the second Novaliq product with positive data in humans," said Mathias Hothum from Novaliq's main investor dievini Hopp BioTech holding GmbH and Co KG.
CyclASol® is the first and only 0.05% cyclosporin solution based on Novaliq's proprietary EyeSol® platform technology. CyclASol® is developed as a clear solution in multi-dose, preservative free bottles for patients with dry eye syndrome and has demonstrated long term stability plus preclinical superior wettability, pharmacokinetics and biocompatibility compared to conventional emulsions.
About Novaliq GmbH
Novaliq is a drug delivery company whose goal is to develop innovative pharmaceutical formulations. Novaliq's proprietary semi-fluorinated alkanes (SFAs) technology can be used in various routes of administration for the transport of drugs or oxygen for therapeutic purposes. Based on its unique physicochemical properties, Novaliq currently develops innovative ophthalmic formulations and has several product candidates with excellent market potential in various stages of development.