Shots:
Roche has received the European CE Mark approval for Contivue, a port delivery platform containing Susvimo (Lucentis) for the treatment of neovascular age-related macular degeneration (nAMD); Susvimo (100mg/mL) is under the EMA’s review
Approval was backed by P-III (Archway) trial & additional studies, a P-II (LADDER) trial, & Portal OLE long-term study, with Archway showing…
Shots:
Roche has reported data from the ongoing OLE P-III (Portal) study of Susvimo (port delivery platform with Lucentis) for the treatment of nAMD
The P-III (Archway) trial assessed Susvimo (Q6W refill, n=248) vs Lucentis (QM, IVT, n=168) in 415 nAMD pts responsive to prior anti-VEGF therapy; 352 entered the Portal OLE study, where 132…
Shots:
The US FDA has approved Susvimo (port delivery platform with Lucentis) for the treatment of diabetic retinopathy (DR)
Approval was based on 1 yr. P-III (Pavilion) trial data assessing Susvimo (100mg/mL, refilled Q9M) vs monthly clinical observation in 173 pts with non-proliferative DR without center-involved DME, where subjects in Susvimo arm received 2 loading…
Shots:
The US FDA has approved Susvimo (port delivery platform with Lucentis) to treat DME
Approval was based on P-III (Pagoda) study assessing Susvimo (100 mg/mL, refilled in Q6M) vs Lucentis (0.5mg, intravitreal, Q1M) in DME pts (n=634), where subjects in
Susvimo arm received 4 loading doses of Lucentis till 16wks. prior to implantation
Study demonstrated sustained vision…

