23 mayo 2011
SYL1001 terminada la Fase Preclinica esta pendiente de iniciar la Fase I para Dolor Ocular . Abstrac presentado en el Congreso ARVO 2011 en Florida .
SYL1001 Targeting TRPV1 Receptor for the Treatment of Ocular Pain associated to Dry Eye Syndrome .
... Results: In vitro and in vivo studies successfully demonstrated that ocular topical administration of SYL1001 was able to reduce TRPV1 levels and ocular pain in New Zealand white rabbits. Moreover, topical administration of SYL1001 prevents ocular pain after pain induction by capsaicin with a similar or higher analgesic effect than the reference analgesic standard. The toxicology experiments performed with SYL1001 by ocular topical route to dogs and rabbits indicated that no side effects were observed during 28-days of treatment. Pharmacokinetic analysis showed that no drug was detected above the detection limit (40 ng/mL) at any time or dose tested.
Conclusions: SYL1001 specifically directed to silence the TRPV1 gene appears to decrease the behavioural response to ocular surface irritation evoked by ocular capsaicin. These channels are involved in the nerve impulse responses to exogenous and endogenous substances mediating inflammation and pain. Toxicology results indicated that SYL1001 did not produce any adverse events related to treatment. SYL1001 has been demonstrated to be safe and efficient in recommended animal models, which suggest this product could be a very good candidate for treatment of ocular pain.
SYL040012 para el tratamiento del glaucoma inicio la Fase I - II en 2010 . Abstract presentado en el Congreso ARVO 2011 en Florida .
SYL040012. Tolerance And Effect On Intraocular Pressure .
... Results:
Local tolerance was excellent. 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. There were statistical differences between area under curve (AUC) of IOP curves on day four with respect to selection day curve (12% decrease) in all volunteers administered with the low level dose of SYL040012 during seven days. Five of them (with an average basal value of IOP higher than the mean value for the whole group) showed reduction higher than 15%. SYL040012 was not detected in blood.
Conclusions:
The Phase I clinical trial for SYL040012 was completed in 30 healthy volunteers. SYL040012 showed excellent local and systemic tolerance after single and multiple administrations to subjects.