Long road to approval for eye drug

Apellis Pharmaceuticals' pegged eye blockbuster Syfovre has finally been approved by the TGA after close to a two-year review, marking the first-ever treatment for adults with geographic atrophy (GA) in Australia.

Delivered via an intravitreal injection, Syfvore is indicated for the every-other-month treatment of adults with GA secondary to age-related macular degeneration (AMD) with an intact fovea and when central vision is threatened by GA lesion growth.

Notably, the TGA accepted a Type C application, also known as a new indication application, for Syfovre in March 2023 because SOBI markets Empaveli, which delivers the same active ingredient (pegcetacoplan) subcutaneously for the treatment of adults with paroxysmal nocturnal haemoglobinuria who have an inadequate response, to, or are intolerant of, a C5 inhibitor.