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Victoria Gonzalez, Javier Moreno-Montañés, Belén Sádaba, Verónica Ruz, Ana Isabel Jímenez; SYL1001 for Treatment of Ocular Discomfort in Dry Eye: Safety and Tolerance (Phase I Study). Invest. Ophthalmol. Vis. Sci. 2012;53(14):575.
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A phase I clinical trial in healthy volunteers has been carried out to evaluate the safety tolerance and pharmacokinetic profile of SYL1001, a new topical treatment for chronic ocular pain and ocular discomfort associated to Dry eye Syndrome.
SYL1001 is a new chemical specifically designed to target Transient Receptor Potential Vanilloid 1 (TRPV1). This nociceptor is involved in pain stimuli transmission. SYL1001 siRNA targeting TRPV1 was administered as eyedrops in saline solution to 30 healthy voluntaries at two different doses (clinical trial Phase I).This study has been reviewed and approved by the Independent Ethic Committee: Comité Ético Investigación Clínica de Navarra and the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). The study was set out in two periods. The first period (n = 6 healthy volunteers) was an initial evaluation of safety using a single dose of product; whereas in the second period (n = 24 healthy volunteers) multiple ascending doses were assayed (a single daily administration in one of the eyes during 7 days). The eye that received the product was randomized. Tolerance and Safety evaluation were performed on both eyes. The ophthalmologist evaluating safety was blind to the experimental condition. The second period began once security and pharmacokinetics of the first period were assured.
Local tolerance was excellent. No serious adverse events were reported in this clinical trial. No modifications of the ocular surface or iris were detected. The analytical results at final examination did not show differences from those observed during selection. Pharmacokinetic results indicated that no levels of siRNAs were detected above LOOQ (40 ng/mL) in any of the subjects. These results were expected as SYL1001 is a non modified siRNAs, with a low stability in plasma (half-life is less than 5 min).
Phase I clinical trial for SYL1001 was completed in 30 healthy volunteers. SYL040012 showed excellent local and systemic tolerance after single and multiple administrations to subjects.
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