With pos­i­tive key tri­al, Kala Phar­ma's dry eye drug Ey­su­vis em­u­lates ap­proval path set by Xi­idra

Mixed da­ta from pre­vi­ous study read­outs on its drug for short-term dry eye re­lief pre­cip­i­tat­ed a re­jec­tion from the FDA, leav­ing Kala Phar­ma­ceu­ti­cals’ fate in the hands of a third study. On Mon­day, that tri­al met its goals, set­ting up the Wa­ter­town, Mass­a­chu­setts-based com­pa­ny to re­sub­mit a mar­ket­ing ap­pli­ca­tion in the sec­ond quar­ter.

The drug, to be brand­ed as Ey­su­vis, con­sis­tent­ly met the main ef­fi­ca­cy goals — but not the symp­tom end­points — across one mid-stage and two late-stage (STRIDE-1 and 2) tri­als. The com­pa­ny, one of the pletho­ra of biotechs that trace their roots to the pro­lif­ic lab at MIT led by Bob Langer, was spurned by the FDA last Au­gust. While dis­ap­point­ing, the CRL was not com­plete­ly un­ex­pect­ed, COO Todd Baze­more said at the time.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.