Product information and disease description Place of product in therapy Approaches to treatment Current treatment options and standard of care

Port delivery system with ranibizumab

5 evidence topics · 5 sources

Archway phase 3 trial: refill-exchange every 24 weeks versus monthly ranibizumab

“Patients with nAMD diagnosed within 9 months of screening previously treated with and responsive to anti-vascular endothelial growth factor therapy.” (opens the source at this quote in a new tab)
“Archway enrolled 418 patients; 251 were randomized to and 248 received treatment with the PDS Q24W, and 167 were randomized to and received treatment with monthly ranibizumab.” (opens the source at this quote in a new tab)
“Prespecified ocular adverse events of special interest were reported in 47 patients (19.0%) in the PDS Q24W arm and 10 patients (6.0%) in the monthly ranibizumab arm, which included, in the former arm, 4 (1.6%) endophthalmitis cases, 2 (0.8%) retinal detachments, 13 (5.2%) vitreous hemorrhages, 6 (2.4%) conjunctival erosions, and 5 (2.0%) conjunctival retractions.” (opens the source at this quote in a new tab)
“Archway met its primary objective and PDS Q24W demonstrated noninferior and equivalent efficacy to monthly ranibizumab, with 98.4% of PDS-treated patients not receiving supplemental treatment in the first 24-week interval.” (opens the source at this quote in a new tab)

FDA-labeled indication and boxed warning for endophthalmitis

“SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.” (opens the source at this quote in a new tab)
“The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.” (opens the source at this quote in a new tab)
“When including extension phases of clinical trials, 2% (11/555) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis.” (opens the source at this quote in a new tab)

Surgical implantation, voluntary recall, and market reintroduction

“The implant is surgically inserted into the eye in the operating room and can be refilled every 6 months with an office procedure.” (opens the source at this quote in a new tab)
“In 2022, the implant was voluntarily recalled due to concerns about septum dislodgment. The implant was re-introduced to the market in 2024.” (opens the source at this quote in a new tab)

Portal extension trial: long-term safety

“In the All-PDS safety population (mean follow-up, 111 weeks), 137 (24.7%) patients had ≥1 ocular AESI; most common were cataract (11.4%), vitreous hemorrhage (6.1%), and conjunctival thickening (bleb)/filtering bleb leak (6.3%).” (opens the source at this quote in a new tab)
“Approximately 95% of patients did not need supplemental treatment before each refill-exchange for >2 years since Portal enrollment.” (opens the source at this quote in a new tab)

Endophthalmitis cases across PDS clinical trials

“Seven cases (7/11 [63.6%]) had preceding/concurrent conjunctival complications.” (opens the source at this quote in a new tab)
“At last follow-up, 7 patients recovered vision to study baseline levels or ≥20/40; 4 patients experienced vision loss of ≥15 ETDRS letters.” (opens the source at this quote in a new tab)