Once re­ject­ed, Kala's dry eye drug now gains en­try to a field where No­var­tis is groom­ing its own block­buster

When the FDA slapped a re­jec­tion on Kala Phar­ma’s dry eye drug last Au­gust, the biotech’s ex­ecs promised in­vestors that a third Phase III study — they had al­ready start­ed at that point — would re­verse their for­tune.

To­day they made good on that promise, clinch­ing an ap­proval for Ey­su­vis, an oc­u­lar cor­ti­cos­teroid be­ing po­si­tioned as a first-line, short term treat­ment of dry eye dis­ease.

Boast­ing a tech­nol­o­gy in­vent­ed by Bob Langer out of MIT, Ey­su­vis is a cor­ti­cos­teroid, lotepred­nol etabon­ate, de­liv­ered by mu­cus-pen­e­trat­ing par­ti­cles. It promis­es to en­hance pen­e­tra­tion in­to tar­get tis­sue on the oc­u­lar sur­face, achiev­ing an ef­fect quick­er than sys­temic cor­ti­cos­teroids and stronger than over-the-counter eye drops.

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