ʻO ka maʻi maka maloʻo: New Clinical Study

ʻO ka haʻawina koʻikoʻi o ka Phase 3 MELODY-1 he kikowaena nui, randomized, double-masked a me ka hoʻokele kaʻa e loiloi ana i ka palekana a me ka pono o ka melanocortin agonist, PL9643 ophthalmic solution, i hoʻohālikelike ʻia me ka kaʻa i nā kumuhana me ka maʻi maka maloʻo (DED). ). Hoʻokumu ʻia ka hoʻolālā haʻawina ma nā hopena maikaʻi o ka Phase 2 o PL9643 no ka mālama ʻana i ka maʻi maka maloʻo, a me kahi hālāwai hope-o-phase 2 (EOP2) me ka US Food and Drug Administration (FDA), hiki i ka ʻaelike ma nā kī āpau. nā mea o kahi papahana lapaʻau Phase 3 koʻikoʻi, me ka hoʻolālā noiʻi, nā hopena, ka loiloi interim, a me ka heluna maʻi. Eia kekahi, no ke kākoʻo ʻana i kahi hoʻopiʻi ʻana i ka New Drug Application (NDA), e koi ʻia kahi haʻawina ʻelua ʻāpana 3 (MELODY-2) a me ka noiʻi palekana lōʻihi (MELODY-3). Inā holomua ka papahana e like me ka mea i hoʻolālā ʻia, loaʻa nā hualoaʻa o ka laina kiʻekiʻe mai MELODY-1 i ka hapalua ʻelua kalena 2022, heluhelu ʻia ka ʻikepili MELODY-2 i ka hapalua ʻelua 2023, me ka waiho ʻana mai o ka NDA i ka hapa mua o ka kalena 2024.

ʻO ka maʻi maka maloʻo he maʻi ʻeha maʻamau i waiho ʻia me ka mālama ʻole ʻia, hiki ke lilo i mea ʻeha loa a alakaʻi i ka pōʻino mau i ka cornea a me ka ʻike. ʻO ka maʻi maka maloʻo e pili ana i ka cornea a me ka conjunctiva o ka maka i ka hopena i ka huhū, ka ʻulaʻula, ka ʻeha, a me ka ʻike maka. Ua manaʻo ʻia e pili ana ma luna o 20 miliona mau kānaka ma ʻAmelika Hui Pū ʻIa. ʻO ka maʻi iʻikeʻia e ka lawaʻole o ka wai a me ka lubrication ma ka mua o ka maka o ka maka, e alakaʻi ana i ka maloʻo, ka mumū, kaʻeha, ka pilikia, ka huhū, ka emiʻana o ka maikaʻi o ke ola, a ma nā hihia koʻikoʻi, kaʻikeʻole mau. ʻO ka lāʻau lapaʻau e kū nei no ka maʻi maka maloʻo i manaʻo ʻia ʻaʻole lawa e nā kauka a me nā maʻi he nui, a koi pinepine i nā pule a i ʻole mau mahina e hōʻike i ka hana.