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Sylentis Completes Phase I Trial with SYL040012 to Treat Elevated Intraocular Pressure and Glaucoma
Date:7/6/2010

MADRID, July 6 /PRNewswire/ -- Sylentis, a biopharmaceutical subsidiary of Grupo Zeltia (MC: ZEL) and a pioneer in the research and development of new drugs based on gene silencing (interference RNA, RNAi), has completed Phase Ia of its first clinical trial with SYL040012 in the form of ophthalmic drops to treat elevated intraocular pressure and glaucoma.

This is the first product based on RNAi technology to be developed clinically in Spain.

The trial received approval from the Spanish Medicines and Health Products Agency in June 2009, and was conducted by specialists in pharmacology and ophthalmology at Navarra University Clinic.

The trial's endpoint was to determine the tolerance and safety of SYL040012 ophthalmic drops; it was administered to 30 healthy volunteers aged 18 to 33. Patients showed excellent local and systemic tolerance to SYL040012, leading to very positive trial results. Sylentis plans to commence a Phase I/II clinical trial in patients with elevated intraocular pressure as soon as possible.

About SYL040012

In preclinical trials with SYL040012, the siRNAs administered topically to treat ocular hypertension associated with open angle glaucoma have proven effective both in vitro and in vivo. In those trials, SYL040012 effectively prevented the increase in intraocular pressure induced in the ocular hypertension model that was used. Ocular tolerance studies have shown excellent local and systemic tolerance to the administration of SYL040012 in much larger doses than required for therapeutic effectiveness.

About Sylentis

Founded in
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