FDA imavomereza Restylane Defyne pakukulitsa nsagwada

Galderma adalengeza kuti FDA yavomereza Restylane Defyne, chodzaza mafuta a HA dermal, kuti chikule chibwano.
Kampani yokongola komanso yopanga mankhwala Galderma posachedwapa yalengeza kuti FDA yavomereza Restylane Defyne kuti ipititse patsogolo ndikuwongolera kugwa kwachibwano pang'ono mpaka pang'ono kwa akulu azaka zopitilira 21.
Restylane Defyne, yomwe idavomerezedwa koyamba mu 2016, ndi hyaluronic acid (HA) dermal filler yomwe idagwiritsidwa ntchito popanga jakisoni wapakatikati mpaka wakuzama mu minofu ya nkhope kuti athetse makwinya amaso apakati mpaka akulu ndi makwinya.
Galderma amagwiritsa ntchito njira yake yapadera yopangira teknoloji ya XpresHAN, yomwe imadziwika padziko lonse kuti Optimal Balance Technology (OBT), kuti ipange gel osakaniza jekeseni yomwe imatha kusakanikirana mosavuta pakhungu kuti ikhale yoyenda mwachilengedwe komanso yamphamvu.
"Izi ndi nthawi yachisanu ndi chitatu yomwe Galderma adalandira chilolezo cha FDA m'zaka za 5, ndipo zikuwonetsa kuti tadzipereka kwa nthawi yaitali kulimbikitsa zokongoletsa pogwiritsa ntchito zatsopano zatsopano," Alisa Lask, woyang'anira wamkulu ndi wachiwiri kwa pulezidenti wa Galderma's American aesthetics bizinesi, adatero. m'nkhani yolengeza kuvomereza.“Chibwano ndiye maziko a nkhope ndipo chimatha kulinganiza mikhalidwe yanu ina.Ogula tsopano atha kugwiritsa ntchito njira zopanda opaleshoni, zotetezeka kuti athetse vuto la chibwano.Mtunduwu umagwiritsa ntchito ukadaulo wa XpresHAN kuti upangike ndikupanga zotsatira zokhalitsa. ”
Chivomerezo cha Restylane Defyne chinapezedwa pambuyo pa deta kuchokera ku mayesero ofunikira a Phase 3 omwe amathandizira chitetezo chake ndi kulekerera pakukulitsa nsagwada.Mwa odwala omwe ali mu phunziroli, 86% sanakumanepo ndi zovuta zilizonse zokhudzana ndi chithandizo, komanso chochitika chimodzi chokha cha ululu wa malo a jekeseni.
Odwala makumi asanu ndi anayi mphambu asanu ndi anayi pa 100 aliwonse adanena za kusintha kwa maonekedwe a chibwano chotuluka (atafunsidwa pa masabata a 12), ndipo 96% ya majekeseni adanena kuti mankhwalawa amawongolera maonekedwe a chibwano chotuluka kwa chaka chimodzi.
Mlanduwu udawonetsa kuti 74% ya odwala anali ndi kusintha kwakukulu kwachibwano kwa nthawi yayitali mpaka chaka chimodzi, poyerekeza ndi 86% pamasabata 12.Izi zimayesedwa pogwiritsa ntchito Gartner's Chin Retraction Scale (GCRS).Zotsatira zokometsera pambuyo pa chithandizo zinali zabwino ndipo zinasonyezedwa ndi mlingo wapamwamba wa kukhutira kwa phunziro mu mafunso a FACE-Q ndi Global Aesthetic Improvement Scale (GAIS).
“Odwala anga nthawi zambiri amabwera kwa ine kudzandifunsa za njira zatsopano zothandizira kuti apitirizebe kukhalabe ndi thanzi labwino.Anthu ambiri amadabwa ndikamafotokozera zotsatira za kukula kwa nsagwada komanso kutsika kwa nkhope yapansi ndiye chinsinsi chothandizira kukopa nkhope, "Anne Chapas, MD, dokotala wodziwika bwino wa dermatologist ndi dermatologist ku New York, komanso wofufuza zachipatala. Kuyesa kwachipatala kwa Restylane Defyne Chin, adatero potulutsa atolankhani."Kumunsi kwa nkhope kumakhala koyenda nthawi zonse, kotero ndikofunikira kuti odwala asankhe zodzaza mphamvu monga Restylane Defyne, zomwe zapangidwa mwasayansi kuti zigwirizane ndi maonekedwe awo a nkhope."