Ukwehla kwamehlo okusha ukwelapha ukubona okufiphele okuhlobene neminyaka

I-Allergan, inkampani yakwa-AbbVie, namuhla imemezele ukuthi uhlolo lweSigaba 3 se-VIRGO oluhlola ukuphepha nokusebenza kophenyo kabili ngosuku ukuphathwa kwe-VUITY™ (isixazululo se-ophthalmic pilocarpine HCl) 1.25% kubantu abadala abane-presbyopia kuhlangabezane nesiphetho salo sokusebenza ngempumelelo, ukuthuthukisa eduze kombono ngaphandle kombono. okuphazamisa umbono webanga ngehora lesi-9 (amahora angu-3 ngemva kokwehla kwesibili) ngoSuku 14. Imininingwane eyengeziwe yalolu cwaningo izokwethulwa ezingqungqutheleni zezokwelapha ezizayo futhi izosebenza njengesisekelo sokufakwa kwesicelo esisha sesidakamizwa esingeziwe sokuphathwa kokuzithandela kabili ngosuku. ku-US Food and Drug Administration (FDA) engxenyeni yesibili ka-2022. Kugunyazwe i-FDA ngo-Okthoba 2021 ukuze isetshenziswe kanye ngosuku, i-VUITY iwukwehla kweso lokuqala nokuwukuphela kwayo ukwelapha ukufiphala okuhlobene nobudala eduze nokubona kubantu abadala.

"Sikhuthazwa yimiphumela yocwaningo lwe-VIRGO, oluphakamisa ukuthi ukuphatha i-VUITY kabili ngosuku kungase kunikeze inketho eyengeziwe ye-dosing kubantu abane-presbyopia ukuze bathuthukise umbono wabo oseduze ngaphandle kokuphazamisa umbono wabo webanga," kusho uChristopher Lievens, OD, umphenyi wesilingo somtholampilo. kanye noprofesa, Southern College of Optometry. "Ngemiphumela yokuphepha efanayo uma iqhathaniswa nezifundo zangaphambilini ezihlola ukuphathwa kanye ngosuku, i-VUITY elawulwa kabili ngosuku ingase inikeze ukuguquguquka okwengeziwe kokuthi kulawulwa kanjani ukufiphala eduze kombono."

Esivivinyweni se-VIRGO Phase 3, isamba sabahlanganyeli be-230 abaneminyaka engu-40 kuya ku-55 ubudala abane-presbyopia bahlelwa ngokungahleliwe ngesilinganiso esisodwa kuya kwesinye semoto (i-placebo) ukuya ku-VUITY, bethola amaconsi amabili esweni ngalinye ngosuku izinsuku ezingu-14, ngokwehla kwesibili ngehora lesi-6 (amahora angu-6 ngemva kokwehla kokuqala). Ucwaningo luhlangabezane nesiphetho salo esiyinhloko, okubonisa inani elibalulekile ngokwezibalo labahlanganyeli abaphathwa nge-VUITY kabili ngosuku bazuze imigqa emithathu (ikhono lokufunda imigqa emithathu eyengeziwe eshadini lombono eliseduze) noma ngaphezulu ku-mesopic (ukukhanya okuphansi), ukugqama okuphezulu, Ibanga le-binocular Kulungiswe I-Near Visual Acuity (DCNVA) ngokulahlekelwa okungaphezu kwezinhlamvu ezingu-5 ekukhanyeni okuphansi Corrected Distance Visual Acuity (CDVA) ngoSuku 14, Ihora lesi-9 (amahora angu-3 ngemva kokuwa kwesibili) uma kuqhathaniswa nemoto (i-placebo).                   

Iphrofayili yokuphepha yayifana naleyo ebonwe ezifundweni zokuphathwa kanye ngosuku kwe-VUITY; izenzakalo ezimbi ezivame kakhulu ezenzeka ngemvamisa ye-> 5% kwakuyikhanda elibuhlungu kanye nokucasuka kwamehlo. Ukusetshenziswa kabili nsuku zonke kwe-VUITY akugunyaziwe futhi ukuphepha nokusebenza kwayo akukahlolwa yi-FDA.

"Siyazi ukuthi abantu abaningi abanokufiphala okuhlobene neminyaka eduze kokubona banesithakazelo ekusetshenzisweni okungase kube khona kwe-VUITY ngaphezu kokuphatha kanye ngosuku ukuze basize ukuphatha isimo sabo," kusho uMichael R. Robinson, MD, iphini likamongameli, inhloko yendawo yokwelapha emhlabeni jikelele, i-ophthalmology. , AbbVie. "Imiphumela yocwaningo lwe-VIRGO ikhombisa umzamo wethu oqhubekayo wokusungula iziguli ezinokufiphala okuhlobene neminyaka eduze nokubona nokuzibophezela ekwandiseni iphothifoliyo yethu ehamba phambili yokwelashwa kwabahlinzeki bamehlo neziguli."