Ocular instillation of tivanisiran was generally well tolerated in both species. Ocular findings in Beagle dogs were limited to microscopic evidence of minimal to moderate periocular inflammation in a few eyes of animals treated with the highest dose-levels (conjunctival erosion, loss of goblet cells and epithelial degeneration). Inflammation resolved by the end of a 4-week recovery period. The only tivanisiran-related finding in NZW rabbits was minimal to mild hypertrophy/hyperplasia in the epithelium of nasolacrimal ducts after 28 days of treatment. These effects were not observed after 6 months of treatment of after recovery period .
FYDES is still ongoing and data is masked. No drug-related Serious Adverse Events have been reported yet in any of the 301 randomized subjects.
El nuevo fármaco en investigación SYL1801 muestra buenas propiedades de estabilidad tanto durante el uso como durante los estudios de ICH a largo plazo. SYL1801 se puede envasar en viales de vidrio o cuentagotas cumpliendo con las especificaciones que garantizan la integridad del medicamento .
No se observaron diferencias tras 12 meses de almacenamiento a largo plazo y en condiciones aceleradas en ninguno de los envases estudiados .
El sistema de cierre de envases Novelia® es capaz de mantener los parámetros (esterilidad y parámetros físico-químicos) tanto en condiciones de uso estándar como en condiciones de mal uso severas .