Tyrvaya (varenicline): Thawj qhov ntswg qhov ntswg los kho qhov muag qhuav!

Oyster Point Pharmaceuticals tsis ntev los no tau tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo Tyrvaya (varenicline) 0.03mg tshuaj tsuag qhov ntswg rau kev kho cov tsos mob thiab cov tsos mob ntawm qhov muag qhuav (DED). Tyrvaya nasal spray yog thawj zaug thiab tsuas yog qhov ntswg tsuag pom zoo rau kev kho qhov muag qhuav. Tyrvaya qhov ntswg tshuaj yog ntseeg tau khi rau cholinergic receptors los qhib cov hlab ntsha trigeminal thiab parasympathetic hlab ntsha txoj hauv kev, yog li ua kom cov basal tsim kua muag zaj duab xis thiab kho qhov muag qhuav.

Tyrvaya nasal spray yog ib qho kev xaiv cholinergic agonist. Nws yog sprayed rau hauv txhua lub qhov ntswg raws li ib tug aqueous nasal tsuag ob zaug ib hnub twg kom qhib basal tsim kua muag. Kev tswj xyuas qhov ntswg muab ib txoj hauv kev tshiab rau kev kho mob ntawm qhov muag qhuav, tsis tas yuav tsum tau tswj hwm ntawm lub qhov muag uas twb raug mob. Tsis tas li ntawd, kev tswj xyuas qhov ntswg tuaj yeem tso cai rau qee cov neeg mob uas muaj teeb meem siv cov tshuaj pleev qhov muag ntawm nws tus kheej los siv lawv cov tshuaj kho qhov muag qhuav.

Tyrvaya tshuaj tsuag qhov ntswg tau kawm hauv ONSET-1, ONSET-2, MYSTIC kev sim tshuaj, koom nrog ntau dua 1,000 tus neeg mob uas mob me, nruab nrab lossis qhov muag qhuav heev. Hauv kev tshawb fawb ONSET-1 thiab ONSET-2, cov neeg mob feem ntau yog poj niam (74%), qhov nruab nrab (tus qauv sib txawv [SD]) hnub nyoog yog 61 (12.5) xyoo, thiab qhov nruab nrab (SD) qhov pib tshuaj loog Schirmer qhab nia yog 5.1 hli. (2.9), Qhov nruab nrab (SD) qhov qhab nia qhov muag qhuav (EDS) yog 59.3 (21.6). Cov kua muag cuav raug tso cai thaum lub sijhawm kawm. Cov txheej txheem nkag suav nrog cov cim qhia ntawm lub cev qis tshaj [piv txwv li Schirmer qhab nia rau tshuaj loog [ntau 0-10mm] thiab corneal fluorescein staining [ntau 2-14]), thiab kev nkag tsis tau txwv los ntawm cov qhab nia ntawm lub qhov muag qhuav (ntau 2-100).

Varenicline-varenicline tshuaj qauv (daim duab qhov chaw: medchemexpress.com)

Kev tsim cov kua muag basal yog ntsuas los ntawm qhov kev hloov pauv ntawm cov tshuaj loog Schirmer piv rau lub hauv paus raws li txoj kev sim uas siv lub ntsuas ntsuas ntsuas kom nqus cov kua muag kua muag thiab ntsuas cov kua muag kua muag. Qhov ziab ntawm qhov muag yog ntsuas los ntawm kev hloov pauv ntawm qhov muag qhuav qhov qhab nia piv nrog cov hauv paus. Qhov no yog qhov pom kev sib piv uas cov neeg mob tau qhab nia qhov tsis xis nyob ntawm qhov muag qhuav. Qhov ntau dua qhov txo qhov qhab nia, qhov ntau dua qhov kev pab cuam ntawm cov tsos mob. Cov qhab nia qhov muag qhuav yog ntsuas nyob rau hauv ib puag ncig tswj tsis zoo (CAE®) thiab chaw kho mob ib puag ncig.

Raws li Schirmer tus qhab nia (0-35 hli) ntawm kev siv tshuaj loog ntawm lub lim tiam 4, cov neeg mob kho nrog Tyrvaya tau pom tias muaj kev txhim kho tseem ceeb hauv kev tsim kua muag zaj duab xis. Tshwj xeeb: Hauv lub lim tiam 4, 52% thiab 47% ntawm cov neeg mob hauv Tyrvaya kev kho mob pab pawg tau ua tiav Schirmer qhab nia nce ntawm ≥10 hli los ntawm cov hauv paus hauv kev kawm ONSET-1 thiab ONSET-2 txoj kev tshawb fawb, raws li, thaum lub tsheb pab pawg. yog 14% Thiab 28% (2 kev tshawb fawb: p< 0.01).="" nyob="" rau="" lub="" lim="" tiam="" thib="" 4,="" hauv="" onset-1="" txoj="" kev="" tshawb="" fawb="" thiab="" kev="" tshawb="" fawb="" onset-2,="" qhov="" kev="" hloov="" pauv="" ntawm="" schirmer="" qhab="" nia="" ntawm="" tyrvaya="" kev="" kho="" mob="" yog="" 11.7="" hli="" thiab="" 11.3="" hli,="" raws="" li="" qhov="" kev="" hloov="" pauv="" hauv="" pawg="" tsheb="" yog="" 3.2="" hli.="" thiab="" 6.3="">

Nyob rau hauv ib puag ncig kev tswj tsis zoo (CAE®), hauv ONSET-1 txoj kev tshawb fawb, qhov nruab nrab hloov pauv ntawm qhov muag qhuav cov qhab nia ntawm cov neeg mob hauv Tyrvaya cov pab pawg kho mob (n=45) piv rau cov hauv paus ntsiab lus yog -16.0 hli hauv lub lim tiam thib peb, thaum Kev hloov pauv nruab nrab ntawm cov neeg mob hauv pawg tsheb (n=42) yog -4.4 hli. Qhov kawg taw tes tau mus txog (p< 0.01).="" hauv="" txoj="" kev="" tshawb="" fawb="" onset-2,="" qhov="" nruab="" nrab="" ntawm="" qhov="" kev="" hloov="" pauv="" ntawm="" qhov="" muag="" qhuav="" ntawm="" cov="" neeg="" mob="" hauv="" pawg="" tyrvaya="" kho="" (n="187)" los="" ntawm="" cov="" hauv="" paus="" ntsiab="" lus="" yog="" -10.3="" hli="" pom="" nyob="" rau="" lub="" lim="" tiam="" 4,="" thaum="" cov="" neeg="" mob="" hauv="" pawg="" tsheb="" (n="169)" cov.="" qhov="" nruab="" nrab="" hloov="" yog="" -7.4="" hli.="" qhov="" kawg="" taw="" tes="" tsis="" tau="" mus="" txog="" (p=""> 0.05).

Hauv qhov chaw kho mob, hauv ONSET-1 txoj kev tshawb fawb, qhov nruab nrab hloov pauv ntawm qhov muag qhuav ntawm pawg Tyrvaya kho (n=46) piv nrog cov hauv paus ntsiab lus yog -18.9 hli hauv Tyrvaya kho pawg (n=46) hauv ONSET-1 txoj kev tshawb fawb, thaum qhov kev hloov pauv nruab nrab ntawm pawg tsheb (n=43) Qhov nruab nrab hloov pauv yog -5.4mm, ncav cuag qhov kawg taw tes (p=0.01). Hauv ONSET-2 txoj kev tshawb fawb, qhov nruab nrab qhov kev hloov pauv ntawm qhov muag qhuav ntawm cov neeg mob hauv Tyrvaya kho pab pawg (n=255) piv rau cov hauv paus yog -19.8 hli, thaum qhov nruab nrab hloov hauv pawg tsheb (n=248) Qhov nruab nrab hloov yog -15.4mm. Txij li qhov kawg ntawm CAE® tsis yog qhov tseem ceeb, qhov kawg theem nrab no tsis ua raws li cov xwm txheej ntawm qhov ntsuas ntsuas thiab tsis ncav cuag.

Hauv kev tshawb nrhiav, txham yog qhov tshwm sim tsis zoo tshaj plaws hauv 82% ntawm cov neeg mob. Cov xwm txheej tau tshaj tawm los ntawm 5-16% ntawm cov neeg mob yog hnoos, caj pas, thiab qhov ntswg qhov ntswg.