AbbVie Vuity (Pilocarpine 1.25%) tau tsim tawm hauv Tebchaws Meskas: 15 feeb ua haujlwm, kav ntev li 6 teev!

Allergan, ib lub koom haum ntawm AbbVie, tsis ntev los no tau tshaj tawm tias nws tau tshaj tawm cov tshuaj ophthalmic tshiab Vuity (pilocarpine, 1.25% qhov muag tee) hauv Teb Chaws Asmeskas kev lag luam, uas yog siv los kho presbyopia, tseem hu ua hnub nyoog cuam tshuam ntsig txog qhov muag tsis pom kev.

Presbyopia tuaj yeem kuaj tau los ntawm tus kws kho qhov muag los ntawm kev kuaj qhov muag. Tus kab mob no yog ib hom kab mob qhov muag uas ua rau lub qhov muag muaj peev xwm ua kom pom tseeb ntawm cov khoom nyob ze. Hauv Tebchaws Meskas, presbyopia cuam tshuam rau 128 lab tus tib neeg, lossis ze li ib nrab ntawm cov neeg laus, feem ntau yog cov neeg laus dua 40 xyoo.

Thaum Lub Kaum Hli 2021, Vuity tau pom zoo los ntawm US FDA ua thawj thiab tsuas yog qhov muag tee tshwj xeeb tsim los kho presbyopia. Vuity yog ib qho tshuaj kho qhov muag ib hnub uas tuaj yeem txhim kho qhov ze thiab nruab nrab tsis pom kev tsis cuam tshuam qhov pom kev deb. Cov ntaub ntawv kho mob theem 3 qhia tau hais tias Vuity tuaj yeem siv tau li ntawm 15 feeb tom qab muab tso rau hauv lub qhov muag, thiab cov nyhuv tuaj yeem kav ntev li 6 teev.

Jag Dosanjh, Tus Lwm Thawj Coj ntawm Allergan Medical Treatment, tau hais tias: "Peb zoo siab heev uas tuaj yeem nqa qhov kev kho mob thawj zaug rau lub khw sai dua li qhov xav tau, tau txais txiaj ntsig ntau lab tus neeg mob presbyopia. Lub hnub nyoog ntsig txog qhov muag Qhov kev hloov tshiab loj hauv kev noj qab haus huv qhia peb txoj kev mob siab rau kev saib xyuas qhov muag thiab nthuav peb cov kev kho mob ua ntej rau cov kws kho qhov muag thiab lawv cov neeg mob."

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 poob ntawm qhov muag' lub peev xwm tsom mus rau cov khoom nyob ze. Hauv ob lub qhov muag uas tsis yog presbyopic, lub lens pob tshab tom qab lub iris tuaj yeem hloov cov duab kom pom lub teeb ntawm lub retina, ua rau nws yooj yim dua los saib xyuas cov khoom ze. Nyob rau hauv presbyopia, lub lens pob tshab yuav nyuaj thiab nws cov duab tsis yooj yim hloov, yog li nws nyuaj rau tsom 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 pupillary modulation.

Vuity yog qhov muag poob siv los kho 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 kom qhov tob ntawm aggregation.

US 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 presbyopia hnub nyoog 40-55 xyoo tau cuv npe hauv ob qhov kev tshawb fawb no. Cov neeg mob no tau muab tso rau ntawm qhov sib piv 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.

Cov txiaj ntsig tau pom tias ob qho kev tshawb fawb tau mus txog qhov kawg ntawm qhov kawg: cov neeg mob uas tau txais kev kho mob Vuity ib hnub ib zaug 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 nyhuv tau nrawm thiab qhov pom kev zoo tuaj yeem kav ntev txog 6 teev.

Tshwj xeeb tshaj yog, nyob rau 30 hnub ntawm kev kho mob thiab 3 teev tom qab qhov muag instillation, piv nrog cov placebo pab pawg neeg, cov pab pawg neeg kho mob Vuity muaj ib tug loj npaum li cas ntawm cov neeg mob nyob rau hauv lub teeb qis, siab contrast, thiab binocular nrug kho nyob ze qhov muag (DCNVA) tau txais. 3 lossis ntau kab (muaj peev xwm nyeem 3 kab ntxiv ntawm daim ntawv nyeem) thiab poob tsis pub ntau tshaj ib kab (5 tsab ntawv). Hauv ob txoj kev tshawb fawb, tsis muaj qhov tshwm sim tsis zoo tshwm sim hauv cov neeg mob hauv pawg kho mob Vuity. Feem ntau cov xwm txheej tsis zoo uas tshwm sim ntawm> 5% yog mob taub hau thiab qhov muag liab.