Eton Phar­ma hand­ed CRL for re­for­mu­lat­ed con­junc­tivi­tis eye drop

Eton Phar­ma’s grand plan to launch an over-the-counter for an oc­u­lar itch that of­ten af­flicts chil­dren has hit a dead end at the FDA, which has is­sued a com­plete re­sponse let­ter for EM-100.

The CRL is al­so bad news for Bausch & Lomb — the eye care spe­cial­ist sub­sidiary of the com­pa­ny for­mer­ly known as Valeant — which had bagged the US rights to the con­junc­tivi­tis drug back in Feb­ru­ary.

“If ap­proved, EM-100 will be the first preser­v­a­tive-free al­ler­gy eye drop avail­able in the Unit­ed States and will al­low us to bet­ter serve the mil­lions of Amer­i­cans that ex­pe­ri­ence itchy eyes due to al­ler­gies,” Joseph Pa­pa, CEO of Bausch Health, said back then.

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