US FDA Pom Zoo AbbVie Vuity (Pilocarpine 1.25%): Nws siv sijhawm 15 feeb los ua haujlwm thiab kav ntev li 6 teev!

Tsis ntev los no, US Food and Drug Administration (FDA) pom zoo AbbVie' s Allergan ophthalmic tshuaj Vuity (pilocarpine, 1.25% qhov muag tee, txoj kev loj hlob: AGN-190584) los kho presbyopia (presbyopia) ), tseem hu ua muaj hnub nyoog txog farsightedness.

Nws yog tsim nyog hais tias Vuity yog thawj qhov muag tee tshwj xeeb siv los kho presbyopia. FDA pom zoo Vuity raws li cov ntaub ntawv los ntawm 2 theem 3 kev tshawb fawb (GEMINI 1, GEMINI 2). Tag nrho ntawm 750 tus neeg mob uas muaj presbyopia tau cuv npe hauv ob qhov kev tshawb fawb no. Cov txiaj ntsig tau pom tias hauv ob qho kev tshawb fawb, Vuity tau mus txog qhov kawg ntawm qhov kawg: kev txheeb xyuas kev txhim kho tseem ceeb hauv kev pom ze, thiab qhov pom kev deb tsis cuam tshuam.

Thaum Lub Xya Hli xyoo no, Allergan tshaj tawm cov txiaj ntsig tiav ntawm Phase 3 GEMINI 1 kev tshawb fawb soj ntsuam ntawm 2021 American Society of Cataract thiab Refractive Surgery (ASCRS) lub rooj sib tham txhua xyoo. Cov ntaub ntawv qhia tau hais tias txoj kev tshawb no tau mus txog qhov kawg ntawm qhov kev ua tau zoo thiab qhov tseem ceeb ntawm qhov kev ua tau zoo thib ob: cov neeg mob uas tau txais kev kho mob Vuity ib hnub twg tau txhim kho qhov pom kev luv luv thiab nruab nrab, thiab qhov pom kev deb tsis cuam tshuam. Tom qab kev tswj hwm Vuity, cov txiaj ntsig tau nrawm thiab qhov pom kev txhim kho tau ntev txog 6 teev.

Cov txiaj ntsig ntawm tus neeg mob daim ntawv tshaj tawm hauv lub rooj sib tham pom tau hais tias nyob rau hauv 7 hnub dhau los ntawm kev sim, piv nrog cov placebo pab pawg, cov neeg mob hauv pab pawg kho mob Vuity tau muaj kev kho mob tseem ceeb thiab kev txhim kho tseem ceeb hauv kev nyeem ntawv zoo thiab kev txaus siab, thiab kev daws teeb meem. presbyopia Kev siv cov cuab yeej txo qis. Qhov kev tshawb pom zoo ntawm txoj kev tshawb fawb txhawb nqa Vuity' lub peev xwm ua thawj kab kev kho mob rau cov neeg mob presbyopia.

Cov qauv tshuaj ntawm pilocarpine

Presbyopia yog ib hom kab mob qhov muag uas tshwm sim uas txo qhov peev xwm ntawm lub qhov muag kom pom tseeb ntawm cov khoom nyob ze thiab cuam tshuam rau cov neeg muaj hnub nyoog ntau dua 40 xyoo. Hauv Tebchaws Meskas, presbyopia cuam tshuam txog ze li ib nrab ntawm cov neeg laus. Presbyopia yog tshwm sim los ntawm qhov muag poob lub peev xwm tsom rau cov khoom ntawm qhov ze. Hauv ob lub qhov muag uas tsis yog presbyopic, pob tshab lo ntsiab muag tom qab lub iris tuaj yeem hloov cov duab kom pom lub teeb ntawm lub retina, ua kom yooj yim rau kev soj ntsuam cov khoom ze. Hauv presbyopia, lub lens pob tshab yuav nyuaj thiab nws cov duab tsis yooj yim hloov, ua rau nws nyuaj rau tsom mus rau cov khoom nyob ze.

Vuity (pilocarpine) yog ib qho kev hloov kho tshiab ntawm Pilocarpine (M-choline receptor agonist), tshwj xeeb tsim los kho tus mob presbyopia. Lub ntsiab mechanism ntawm qhov kev txiav txim yog ua rau kom cov qhov tob ntawm ua kom pom tseeb los ntawm constricting tus menyuam kawm ntawv, kev txhim kho nyob ze thiab intermediate tsis pom kev, thaum tswj cov menyuam kawm ntawv' s lo lus teb rau txawv teeb pom kev zoo tej yam kev mob. Cov nyhuv no yog hu ua dynamic pupil modulation.

Vuity yog qhov muag poob rau kev kho mob presbyopia. Raws li tshuaj pleev ib ce, nws yog instilled rau hauv lub qhov muag ib hnub ib zaug. Tom qab tso rau hauv lub qhov muag, cov nyhuv yuav siv tau li ntawm 15 feeb, thiab cov nyhuv yuav siv tau ntev, thiab tus neeg mob tuaj yeem nyeem tau yam tsis muaj tsom iav. Nws yuav tsum tau taw qhia tias Vuity tsis tuaj yeem kho tus mob presbyopia, tab sis nws tuaj yeem txo nws cov tsos mob. Cov tshuaj tsis ua rau lub lens, tab sis shrinks cov menyuam kawm ntawv, tsim ib tug pinhole nyhuv los ntawm constricting cov menyuam kawm ntawv thiab ua rau kom qhov tob ntawm aggregation.

Tag nrho ntawm 323 tus neeg mob presbyopia tau tso npe rau hauv GEMINI 1 txoj kev tshawb fawb. Cov neeg mob no tau muab tso rau ntawm qhov sib piv ntawm 1: 1 thiab tau txais Vuity lossis placebo (cov tshuaj tsis muaj qhov muag tee) tso rau hauv ob lub qhov muag (ob lub qhov muag) ib hnub ib zaug rau 30 hnub txuas ntxiv.

Txoj kev tshawb no mus txog qhov tseem ceeb thiab qhov tseem ceeb thib ob kawg: ntawm 3rd teev (22.5%, p< 0.0001)="" thiab="" 6="" teev="" (9.7%,="" p="0.0114)" nyob="" rau="" hnub="" 30,="" pawg="" kho="" mob="" vuity="" piv="" nrog="" cov="" placebo.="" pab="" pawg,="" ib="" qho="" kev="" txheeb="" xyuas="" qhov="" feem="" pua="" ​​​​ntawm="" cov="" neeg="" mob="" tau="" txais="" 3="" lossis="" ntau="" dua="" kab="" hauv="" qhov="" tsis="" tshua="" muaj="" teeb="" pom="" kev="" zoo,="" qhov="" sib="" txawv="" siab,="" kho="" qhov="" muag="" pom="" ze="" ze="" (dcnva)="" (muaj="" peev="" xwm="" nyeem="" 3="" kab="" ntxiv="" ntawm="" daim="" ntawv="">

Cov txiaj ntsig tseem pom tau tias tom qab 30 hnub ntawm kev tswj hwm, Vuity muaj lub sijhawm pib sai ntawm 15 feeb thiab lub sijhawm ntev txog 6 teev nyob rau hauv lub teeb qis DCNVA, tsis cuam tshuam rau kev pom kev deb. Lwm qhov kawg ntawm qhov kev ntsuam xyuas tau pom tias 75% ntawm cov neeg mob hauv pab pawg kho mob Vuity tau ua tiav lub teeb pom kev zoo DCNVA qis dua ≥2 kab, thiab 93% ntawm cov neeg mob ua tiav qhov pom kev pom ≥20/40 hauv photopic (hnub ci) DCNVA . Nyob rau hnub 30, qhov kev ncua deb kho qhov muag nruab nrab (DCIVA) kuj tau soj ntsuam kom txhim kho mus txog 10 teev.

Nyob rau hauv txoj kev tshawb no, tsis muaj teeb meem loj tshwm sim thaum lub sij hawm kho mob nyob rau hauv ib tug neeg mob kho nrog Vuity. Qhov tshwm sim tsis zoo tshwm sim feem ntau (> 5%) thaum lub sijhawm kho mob hauv pab pawg kho mob Vuity tau mob taub hau. Feem ntau cov kev mob tshwm sim yog mob me thiab luv luv, tsuas yog 1.2% ntawm cov neeg mob txiav cov tshuaj vim yog cov xwm txheej tsis zoo.