Orasis Pharmaceuticals CEO Elad Kedar (L) and president and COO Paul Smith

Ora­sis gains FDA ap­proval for pres­by­opia eye drops, fol­low­ing in Ab­b­Vie’s foot­steps

Ora­sis Phar­ma­ceu­ti­cals has se­cured ap­proval in the US for its age-re­lat­ed blur­ry vi­sion eye drops, mark­ing the sec­ond time the FDA has green­lit a pres­by­opia treat­ment.

The OK for Qlosi comes a few days ahead of the FDA de­ci­sion dead­line, which is Sun­day. The eye drops, which can be dosed up to twice dai­ly, will be­come avail­able in the first half of next year, Ora­sis said.

Ab­b­Vie snagged the first FDA clear­ance for blur­ry vi­sion eye drops in 2021, with Vuity, but the Chica­go-area Big Phar­ma took a $770 mil­lion pre-tax im­pair­ment charge last fall when it de­cid­ed to pull back on its big sales and mar­ket­ing spend. The phar­ma gi­ant then axed a sec­ond-gen­er­a­tion pres­by­opia as­set, End­points News re­port­ed ear­li­er this year. Mean­while, oth­er com­pa­nies have can­di­dates in Phase III, in­clud­ing Vi­a­tris-part­nered Ocuphire Phar­ma, Lenz Ther­a­peu­tics and Vi­s­us Ther­a­peu­tics, which plans to file an NDA in the sec­ond half of 2024, pend­ing re­sults from an­oth­er tri­al slat­ed to read out lat­er this year.

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