Kudonha kweziso idzva kurapa kusaona kwakajeka kune zera

Allergan, kambani yeAbbVie, nhasi yazivisa kuti Phase 3 VIRGO kuyedza kuongorora kuchengetedzeka uye kugona kwekuferefeta kaviri-zuva nezuva kutonga kweVUITY™ (pilocarpine HCl ophthalmic solution) 1.25% muvakuru vane presbyopia yakasangana nemhedzisiro yayo yekutanga, kuvandudza pedyo nekuona pasina. kukanganisa maonero echinhambwe paAwa 9 (maawa matatu mushure mekudonha kwechipiri) paZuva 3. Mamwezve mamwe emuyedzo uyu achaunzwa kumakongiresi ezvekurapa anotevera uye achashanda sehwaro hwekuwedzera kweNew Drug Application kutumira kune sarudzo kaviri-zuva nezuva kutonga. kuUS Food and Drug Administration (FDA) muchikamu chechipiri che14. Yakatenderwa neFDA muna Gumiguru 2022 kuti ishandiswe kamwe chete pazuva, VUITY ndiyo yekutanga uye chete inodonha ziso kurapa kusviba kwezera pedyo nekuona muvakuru.

"Tinokurudzirwa nemhedzisiro kubva muyedzo yeVIRGO, iyo inoratidza kuti kupa VUITY kaviri pazuva kunogona kupa imwe dosing sarudzo kune vanhu vane presbyopia kuti vavandudze kuona kwavo kwepedyo pasina kukanganisa kuona kwavo kure," akadaro Christopher Lievens, OD, muongorori wekiriniki. uye purofesa, Southern College yeOptometry. "Nemhedzisiro yakafanana yekuchengetedza zvichienzaniswa nezvidzidzo zvakapfuura zvinoongorora kutonga kamwe-zuva nezuva, VUITY inopihwa kaviri zuva nezuva inogona kupa kushanduka-shanduka mumabatiro ari pedyo nekuona anogadziriswa."

Muchiyedzo cheVIRGO Phase 3, huwandu hwevatori vechikamu 230 vane makore makumi mana kusvika makumi mashanu ane makore makumi mashanu neshanu vane presbyopia vakaverengerwa mune imwe-kune-imwe chiyero chemotokari (placebo) kuenda kuVUITY, vachigamuchira madonhwe maviri muziso rimwe nerimwe pazuva kwemazuva gumi nemana, nedonhwe rechipiri paAwa 40 (maawa matanhatu mushure mekudonha kwekutanga). Chidzidzo ichi chakasangana nemagumo ekutanga, zvichiratidza huwandu hwakakosha hwevatori vechikamu vanobatwa neVUITY kaviri pazuva vakawana mitsetse mitatu (kukwanisa kuverenga mitsara mitatu yekuwedzera pane yepedyo chati yechiratidzo) kana kupfuura mumesopic (yakaderera mwenje), musiyano mukuru, binocular Distance. Yakagadziriswa Near Visual Acuity (DCNVA) isina kudarika 55-tsamba kurasikirwa muchiedza chakaderera Corrected Distance Visual Acuity (CDVA) paZuva 14, Awa 6 (6 maawa mushure mekudonha kwechipiri) zvichienderana nemotokari (placebo).                   

Nhoroondo yekuchengetedza yakanga yakafanana neyakaonekwa mune zvidzidzo nekamwe-zuva nezuva kutonga kweVUITY; zviitiko zvakanyanya kuipa zvinowanzoitika pane imwe nguva> 5% yaiva yemusoro uye kutsamwa kweziso. Iko kushandiswa kweVUITY kaviri-zuva nezuva hakuna kubvumidzwa uye kuchengetedzeka kwayo uye kushanda kwayo hakuna kuongororwa neFDA.

"Tinoziva kuti vanhu vazhinji vane zera-ane-blurry pedyo nekuona vanofarira kushandiswa kweVUITY kudarika kamwe-zuva nezuva kutonga kuti vabatsire kugadzirisa mamiriro avo ezvinhu," akadaro Michael R. Robinson, MD, mutevedzeri wemutungamiri, mukuru wepasi rose werapeutic area, ophthalmology. , AbbVie. "Migumisiro yemuyedzo weVIRGO inoratidza kuenderera mberi kwedu kwekuedza kuvandudza kune varwere vane zera rakasvibirira padyo nekuona uye kuzvipira kuwedzera yedu inotungamira portfolio yekurapa kwevanochengeta maziso nevarwere."