Susvimo (Page 4 of 7)
5.7 Conjunctival Bleb
A conjunctival bleb is an encapsulated elevation of the conjunctiva above the implant flange, which may be secondary to subconjunctival thickening or fluid. Conjunctival blebs may require surgical management to avoid further complications, especially if the implant septum is no longer identifiable due to the conjunctival bleb.
In clinical trials of SUSVIMO including extension phases, 5.9% (26/443) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye. Strict adherence to the scleral incision length, appropriate intraoperative handling of conjunctiva and Tenon’s capsule to preserve tissue integrity and secure closure of peritomy, and proper seating of the refill needle during refill-exchange procedures may reduce the risk of conjunctival bleb.
5.8 Postoperative Decrease in Visual Acuity
Visual acuity was decreased by 4 letters on average in the first postoperative month and 2 letters on average in the second postoperative month following initial implantation of SUSVIMO [see Clinical Studies (14)].
5.9 Air Bubbles Causing Improper Filling of the Implant
Minimize air bubbles within the implant reservoir as they may cause slower drug release. During the initial fill procedure, if an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant. If excess air is observed after initial fill, do not use the implant. During the refill-exchange procedure, if excess air is present in the syringe and needle do not use the syringe and needle. If excess air bubbles are observed after the refill-exchange procedure, consider repeating the refill-exchange procedure.
5.10 Deflection of the Implant
Use caution when performing ophthalmic procedures that may cause deflection of the implant and subsequent injury. For example, B-scan ophthalmic ultrasound, scleral depression, or gonioscopy.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Endophthalmitis [see Warnings and Precautions (5.1)]
- Rhegmatogenous Retinal Detachment [see Warnings and Precautions (5.2)]
- Implant Dislocation [see Warnings and Precautions (5.3)]
- Vitreous Hemorrhage [see Warnings and Precautions (5.5)]
- Conjunctival Erosion or Retraction [see Warnings and Precautions (5.6)]
- Conjunctival Bleb [see Warnings and Precautions (5.7)]
- Postoperative Decrease in Visual Acuity [see Warnings and Precautions (5.8)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
The data below (Table 2) reflect exposure of 248 patients with nAMD in the Archway study following the SUSVIMO initial fill and implant insertion, refill, and implant removal (if necessary) procedures up to Week 40. In this patient population the most common (≥ 10%) adverse reactions up to Week 40 were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%).
| Adverse Reactions | Week 40 | |
|---|---|---|
| SUSVIMOn = 248 | Intravitreal ranibizumabn = 167 | |
| ||
| Conjunctival hemorrhage | 72% | 6% |
| Conjunctival hyperemia | 26% | 2% |
| Iritis * | 23% | 0.6% |
| Eye pain | 10% | 5% |
| Vitreous floaters | 9% | 2% |
| Conjunctival bleb/ filtering bleb leak † | 9% | 0 |
| Foreign body sensation in eyes | 7% | 1% |
| Headache ‡ | 7% | 2% |
| Hypotony of eye | 6% | 0 |
| Vitreous detachment | 6% | 5% |
| Vitreous hemorrhage | 5% | 2% |
| Conjunctival edema | 5% | 0 |
| Corneal disorder | 4% | 0 |
| Corneal abrasion § | 4% | 0.6% |
| Corneal edema | 4% | 0 |
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immune response in patients treated with ranibizumab including SUSVIMO. The detection of an immune response is highly dependent on the sensitivity, specificity, and drug tolerance level of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the study described below with the incidence of antibodies in other studies or to other products may be misleading.
In previously treated nAMD patients, anti-ranibizumab antibodies were detected in 2.1% (5 of 243) of patients prior to insertion of the SUSVIMO implant. After the SUSVIMO implant insertion and treatment, anti-ranibizumab antibodies developed in 12% (29 of 247) patients. No clinically meaningful differences in the pharmacokinetics, efficacy, or safety in patients with treatment-emergent anti-ranibizumab antibodies were observed.
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