AbbVie Xa Nws Qhov Muag Tshuaj Tshiab Tshiab Daim Ntawv Thov rau Kev Kho Mob ntawm Presbyopia

AbbVie / Allergan tshaj tawm tias nws tau xa daim ntawv thov tshuaj tshiab (NDA) rau AGN-190584 (1.25% pilocarpine qhov muag dauv) mus rau Asmeskas FDA rau kev kho mob ntawm presbyopia. FDA yuav tsum ua kev txiav txim siab pom zoo ua ntej xyoo 2021.

Presbyopia yog ib qho kev hloov kho qhov muag uas txo qhov muaj peev xwm ntawm lub qhov muag tsom rau cov khoom siv ze thiab feem ntau cuam tshuam rau cov neeg laus dua 40 xyoo. Txawm li cas los xij, piv nrog lwm cov kab mob qhov muag, paub txog ntawm presbyopia tseem muaj tsawg. Muaj kwv yees li ntawm 128 lab tus neeg mob presbyopia hauv Tebchaws Meskas.

AbbVie' s daim ntawv thov yog feem ntau raws li cov txiaj ntsig ntawm ob theem III kev tshawb nrhiav code-npe GEMINI 1 thiab GEMINI 2. Qhov kev soj ntsuam tau soj ntsuam kev ua tau zoo, kev nyab xeeb thiab tiv taus ntawm AGN-190584 (1.25% pilocarpine qhov muag dauv). Tag nrho ntawm 750 tus neeg mob tau sau npe, thiab AGN-190584 thiab cov placebo tau muab faib ua cov pab pawg ntawm 1: 1. Ob txoj kev tshawb no mus txog qhov kawg. Piv nrog tshuaj placebo, AGN-190584 txhim kho ze ze ntawm qhov pom kev hauv qhov chaw dim, thiab tsis ua rau pom kev tsis pom deb. Ntawm cov ncauj lus tau kho nrog AGN-190584, qhov tshwm sim feem ntau (%5%) tsis tshwm sim loj heev yog mob taub hau thiab mob pob txha hyperemia. Tsis muaj kev kho hais txog kev mob nyhav tshwm sim. Cov ncauj lus kom ntxaws ntawm txoj kev tshawb fawb yuav tshaj tawm hauv cov rooj sib tham kho mob hauv lub sijhawm ze.

AGN-190584 yog kev txhim kho tshuaj tshiab ntawm kev tsim cov tshuaj pilocarpine (cholinergic muscarinic receptor agonist), uas tau tsim los ua qhov muag ib zaug rau qhov muag pom kev kho presbyopia. AGN-190584 tuaj yeem ua lub muscarinic receptors ntawm cov leeg zoo (xws li iris sphincter thiab ciliary leeg). Los ntawm qhov kev cog lus ntawm iris sphincter, cov tub ntxhais kawm ua kom qhov tob ntawm kev ua kom pom tseeb thiab txhim kho qhov pom kev tsis pom kev zoo, thaum tswj hwm tus menyuam' s teb rau lub teeb. AGN-190584 tuaj yeem cog lus rau ciliary cov leeg thiab txhim kho kev yoog raws.

Raws li 1399 cov lus nug txog kev tshawb fawb ntawm cov neeg nruab nrab uas muaj hnub nyoog 40-55 hauv Tebchaws Meskas, 90% ntawm cov pej xeem muaj mob los ntawm presbyopia. Tom Hudson, tus lwm thawj coj loj thiab MD ntawm AbbVie R& D, hais tias:" Presbyopia cuam tshuam rau cov laus feem ntau hnub nyoog 40 xyoo. Cov kev kho mob tam sim no feem ntau ua rau tsis zoo lossis cuam tshuam, xws li siv tsom iav nyeem thiab tsom iav. Yog tias AGN-190584 tuaj yeem pom zoo, nws yuav yog thawj qhov muag poob rau kev kho mob presbyopia, uas tuaj yeem muab cov kev xaiv kho mob tshiab rau cov neeg mob Asmeskas."

Tam sim no, tsis muaj kev pom zoo rau cov tshuaj presbyopia hauv ntiaj teb, thiab tam sim no muaj 3 cov tshuaj nyob hauv kev tshawb fawb theem III. Lub Yim Hli 11, xyoo tas los, JiMu Biotechnology tau txais txoj cai kev tsim kho ntawm MicroPine, ib qho kev kho mob tshiab rau myopia thiab MicroLine, ib qho kev kho mob tshiab rau presbyopia, hauv Greater Tuam Tshoj thiab Kaus Lim Qab Teb los ntawm Eyeovia ntawm Tebchaws Asmeskas rau US $ 47.5 lab.