Sylentis claimed that the trial result was positive. In the trial, the patients demonstrated local and systemic tolerance to SYL040012.
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.
Sylentis said that the trial received the Spanish Medicines and Health Products Agency’s approval in June 2009.
In preclinical trials SYL040012 prevented the increase in intraocular pressure induced in the ocular hypertension model that was used.
Ocular tolerance studies showed positive results and demontrated local and systemic tolerance to the administration of SYL040012 in much larger doses than required for therapeutic effectiveness.
Going forward, Sylentis plans to initiate a Phase I/II clinical trial in patients with elevated intraocular pressure soon.