Allergan, k'hamphani ea AbbVie, kajeno e phatlalalitse hore teko ea Phase 3 VIRGO e hlahlobang ts'ireletseho le katleho ea lipatlisiso tsa tsamaiso ea letsatsi le letsatsi ea VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% ho batho ba baholo ba nang le presbyopia e fihlile qetellong ea eona ea katleho, e ntlafatsa haufi le pono ntle le pono. ho sekisetsa pono ea sebaka ka Hora ea 9 (lihora tsa 3 ka mor'a ho theoha ha bobeli) ka Letsatsi la 14. Lintlha tse eketsehileng tsa teko ena li tla hlahisoa likopanong tsa bongaka tse tlang 'me li tla sebetsa e le motheo oa tlhahiso ea tlatsetso ea New Drug Application bakeng sa tsamaiso ea boikhethelo habeli ka letsatsi ho Tsamaiso ea Lijo le Lithethefatsi ea US (FDA) karolong ea bobeli ea 2022. E amohetsoe ke FDA ka Mphalane 2021 bakeng sa tšebeliso ea hang ka letsatsi, VUITY ke lerotholi la pele le le leng feela la ho phekola lerootho le amanang le lilemo haufi le pono ho batho ba baholo.
"Re khothatsoa ke liphetho tsa teko ea VIRGO, e fanang ka maikutlo a hore ho fana ka VUITY habeli ka letsatsi ho ka fana ka khetho e eketsehileng ea dosing bakeng sa batho ba nang le presbyopia ho ntlafatsa pono ea bona e haufi ntle le ho senya pono ea bona ea hole," ho boletse Christopher Lievens, OD, mofuputsi oa liteko tsa tleliniki. le moprofesa, Southern College of Optometry. "Ka liphetho tse ts'oanang tsa polokeho ha li bapisoa le liphuputso tse fetileng tse hlahlobang tsamaiso ea hang ka letsatsi, VUITY e tsamaisoang habeli ka letsatsi e ka fana ka maemo a bonolo mabapi le hore na pono e haufi e laoloa joang."
Tekong ea VIRGO Phase 3, kakaretso ea barupeluoa ba 230 ba lilemo li 40 ho isa ho tse 55 ba nang le presbyopia ba ile ba khethoa ka sekhahla sa koloi (placebo) ho isa ho VUITY, ba amohela marotholi a mabeli leihlong ka leng ka matsatsi a 14, ka lerotholi la bobeli ka Hora ea 6 (lihora tse 6 ka mor'a lerotholi la pele). Boithuto bona bo fihletse ntlha ea eona ea mantlha, e bonts'a palo ea barupeluoa ba tšoaroang ka VUITY habeli ka letsatsi ba fumane mela e meraro (bokhoni ba ho bala mela e meraro ho chate e haufi ea pono) kapa ho feta ka mesopic (leseli le tlase), phapang e phahameng, bohole ba li-binocular. E Lokisitsoe Haufi le Visual Acuity (DCNVA) e nang le tahlehelo e fetang 5 ea litlhaku ka leseli le tlaase Corrected Distance Visual Acuity (CDVA) ka Letsatsi la 14, Hora ea 9 (lihora tsa 3 ka mor'a ho theoha ha bobeli) khahlanong le koloi (placebo).
Boemo ba polokeho bo ne bo ts'oana le bo bonoang lithutong tsa tsamaiso ea hang ka letsatsi ea VUITY; liketsahalo tse mpe tse atileng haholo tse etsahalang khafetsa> 5% e ne e le hlooho le ho halefa ha mahlo. Tšebeliso ea letsatsi le letsatsi ea VUITY habeli ha e amoheloe mme polokeho ea eona le katleho ea eona ha e so hlahlojoe ke FDA.
"Rea tseba hore batho ba bangata ba nang le bothata bo amanang le lilemo tse haufi le pono ba thahasella tšebeliso e ka bang teng ea VUITY ho feta tsamaiso ea hang-hang ka letsatsi ho thusa ho laola boemo ba bona," ho boletse Michael R. Robinson, MD, motlatsi oa mopresidente, hlooho ea sebaka sa phekolo ea lefats'e, ophthalmology. , AbbVie. "Liphetho tsa teko ea VIRGO li bonts'a boiteko ba rona bo tsoelang pele ba ho qapa bakuli ba nang le lerootho e amanang le lilemo haufi le pono le boitlamo ba ho holisa liphekolo tsa rona tse etellang pele tsa kalafo bakeng sa bafani ba tlhokomelo ea mahlo le bakuli."
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- The study met its primary endpoint, showing a statistically significant proportion of participants treated with VUITY twice daily gained three lines (the ability to read three additional lines on a near vision chart) or more in mesopic (low light), high contrast, binocular Distance Corrected Near Visual Acuity (DCNVA) with no more than 5-letter loss in low light Corrected Distance Visual Acuity (CDVA) at Day 14, Hour 9 (3 hours after the second drop) versus the vehicle (placebo).
- In the VIRGO Phase 3 trial, a total of 230 participants aged 40 to 55 years old with presbyopia were randomized in a one-to-one ratio of vehicle (placebo) to VUITY, receiving two drops in each eye per day for 14 days, with the second drop at Hour 6 (6 hours after the first drop).
- Additional details of this trial will be presented at future medical congresses and will serve as the basis for a supplemental New Drug Application submission for an optional twice-daily administration to the U.
