BioWorld tracked 215 clinical trial readouts spanning phases I through III in December 2025, a sizeable increase from 170 updates in November, but below the 252 reported in October.
Attention has turned to the regulatory path worldwide after Belite Bio Inc. unveiled positive top-line data from the phase III Dragon study with oral, daily tinlarebant in Stargardt disease type 1, the most common form of the rare affliction.
Iveric Bio Inc.’s regulatory win Aug. 4 drew attention to the already hot eye-disease space, where intriguing new developments include the possibility of an oral therapy for Stargardt disease. Belite Bio Inc. in late July finished enrollment of a phase III study with once daily tinlarebant, a retinol binding protein 4 antagonist for Stargardt’s. Data from 90 adolescent subjects in the study called Dragon are due in mid-2024.
Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023.
Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023.
The phase III miss disclosed Aug. 11 by Kubota Pharmaceutical Holdings Co. Ltd. subsidiary Kubota Vision Inc. in Stargardt disease put more eyes on the rare, inherited, juvenile-onset form of macular degeneration, for which nothing is approved.
