The approval follows a refiling after the FDA issued a Complete Response Letter due to language on the amended label.

Apellis received FDA approval for intravitreal pegcetacoplan (SYFOVRE) to treat geographic atrophy secondary to AMD. This news follows the submission of the 24-month phase 3 data in November 2022.

Among these eyes, 18.9% of eyes developed nAMD within 36 months.

The phase 1b trial will enrol patients with geographic atrophy secondary to age-related macular degeneration (AMD), a leading cause of blindness. While there are multiple therapies available for ...

Astellas has shored up the competitive profile of Izervay as a treatment for eye disorder geographic atrophy (GA), getting FDA approval for an extended treatment duration. The US regulator turned ...

Among patients diagnosed with intermediate-stage age-related macular degeneration, a fair number of eyes in a new analysis showed evidence of geographic atrophy (GA), a leading cause of blindness.

The companies have successfully executed all milestones to date. About Geographic Atrophy (GA) GA is a chronic, progressive and irreversible retinal disease that occurs in people with late-stage ...

CDR-Life today announced the achievement of the fifth milestone under its collaboration and licensing agreement with Boehringer Ingelheim in the advancement of BI 771716, a novel therapeutic candidate ...

ZÜRICH--(BUSINESS WIRE)--CDR-Life today announced the achievement of the fifth milestone under its collaboration and licensing agreement with Boehringer Ingelheim in the advancement of BI 771716, a ...