ʻO ka kulu maka hou e mālama i ka ʻike pohihihi pili makahiki

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Ua hoʻolaha ʻo Allergan, kahi hui AbbVie, i kēia lā i ka hoʻāʻo ʻana o ka Phase 3 VIRGO e loiloi ana i ka palekana a me ka maikaʻi o ka hoʻokolokolo ʻana i ʻelua mau lā o ka lawelawe ʻana o VUITY ™ (pilocarpine HCl ophthalmic solution) 1.25% i nā pākeke me ka presbyopia i hoʻokō i kona hopena hopena maikaʻi, hoʻomaikaʻi kokoke i ka ʻike ʻole. hoʻololi i ka ʻike mamao ma ka hola 9 (3 mau hola ma hope o ka hāʻule ʻana o ka lua) i ka lā 14. E hōʻike ʻia nā kikoʻī hou aku o kēia hoʻokolokolo ma nā ʻaha kūkā lapaʻau e hiki mai ana a e lilo ia i kumu no ka hoʻouna ʻana i ka palapala noi lāʻau hou hou no ka hoʻokele koho ʻelua i kēlā me kēia lā. i ka US Food and Drug Administration (FDA) i ka hapaha ʻelua o 2022. Apono ʻia e ka FDA i ʻOkakopa 2021 no ka hoʻohana ʻana i hoʻokahi lā i kēlā me kēia lā, ʻo VUITY ka mea mua a me ka hāʻule wale nō o ka maka e mālama i ka pohu e pili ana i ka makahiki kokoke i ka ʻike i nā pākeke.

"Hoʻoikaika ʻia mākou e nā hopena mai ka hoʻokolokolo VIRGO, e hōʻike ana i ka lawelawe ʻana i ka VUITY ʻelua i kēlā me kēia lā hiki ke hāʻawi i kahi koho dosing hou no ka poʻe me ka presbyopia e hoʻomaikaʻi i ko lākou ʻike kokoke me ka ʻole e hoʻololi i kā lākou ʻike mamao," wahi a Christopher Lievens, OD, ka mea noiʻi hoʻokolohua lapaʻau. a he polopeka, Southern College of Optometry. "Me nā hopena palekana e like me ka hoʻohālikelike ʻana i nā haʻawina mua e loiloi ana i ka hoʻokele hoʻokahi-lā i kēlā me kēia lā, ʻo VUITY lawelawe ʻia ʻelua i kēlā me kēia lā hiki ke hāʻawi i ka maʻalahi i ka hoʻokele ʻana o ka ʻike polū."

I ka VIRGO Phase 3 hoʻāʻo, he 230 mau mea komo mai 40 a 55 mau makahiki me ka presbyopia i randomized i ka ratio hoʻokahi-a-hoʻokahi o ka kaʻa (placebo) i VUITY, e loaʻa ana ʻelua kulu i kēlā me kēia maka i kēlā me kēia lā no 14 mau lā, me ka hāʻule lua ma ka hola 6 (6 hola ma hope o ka hāʻule mua). Ua loaʻa ka haʻawina i kona wahi hope mua, e hōʻike ana i ka helu helu nui o nā poʻe i mālama ʻia me VUITY ʻelua mau lā i loaʻa i ʻekolu laina (ka hiki ke heluhelu i ʻekolu mau laina hou ma ka pakuhi ʻike kokoke) a i ʻole ma ka mesopic (mālamalama haʻahaʻa), ʻokoʻa kiʻekiʻe, mamao binocular Hoʻoponopono ʻia ʻo Near Visual Acuity (DCNVA) me ka poho ʻole ma mua o 5 mau leka i ka mālamalama haʻahaʻa.                   

Ua like ka ʻike palekana me ka mea i ʻike ʻia ma nā haʻawina me ka lawelawe ʻana o VUITY i hoʻokahi lā i kēlā me kēia lā; ʻO nā hanana maʻamau i loaʻa ma kahi alapine o> 5% he poʻo a me ka huhū maka. ʻAʻole ʻae ʻia ka hoʻohana ʻana o VUITY ʻelua i kēlā me kēia lā a ʻaʻole i loiloi ʻia kona palekana a me ka pono e ka FDA.

"Ua ʻike mākou he nui ka poʻe me ka pohō e pili ana i ka makahiki e pili ana i ka hihiʻo e hoihoi i ka hoʻohana ʻana o VUITY ma mua o ka hoʻokele ʻana i hoʻokahi lā e kōkua i ka mālama ʻana i ko lākou kūlana," wahi a Michael R. Robinson, MD, hope pelekikena, poʻo o ka honua therapeutic area, ophthalmology. , AbbVie. "ʻO nā hopena o ka hoʻokolokolo VIRGO e hōʻike ana i kā mākou hoʻoikaika mau ʻana i ka hana hou no nā poʻe maʻi me ka blurry e pili ana i ka makahiki kokoke i ka ʻike a me ka hoʻokō ʻana i ka hoʻonui ʻana i kā mākou papa kuhikuhi alakaʻi no nā mea mālama maka a me nā maʻi."

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Linda Hohnholz

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