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warnings and cautions
5 WARNINGS AND PRECAUTIONS The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, and conjunctival blebs. Patients should be instructed to report any signs or symptoms that could be associated with these events without delay. In some cases, these events can present asymptomatically. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion, and refill-exchange procedures to permit early medical or surgical intervention as necessary. Special precautions need to be taken when handling SUSVIMO components [see How Supplied/Storage and Handling (16.3) ]. The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival retraction, conjunctival erosion, and conjunctival bleb. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required. ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) Vitreous Hemorrhage : Temporarily discontinue antithrombotic medication prior to the implant insertion procedure to reduce the risk of vitreous hemorrhage. Vitrectomy may be needed. ( 5.5 ) Postoperative Decrease in Visual Acuity : A decrease in visual acuity usually occurs over the first two postoperative months. ( 5.8 ) 5.1 Endophthalmitis In the active comparator period of controlled clinical trials in AMD, the ranibizumab implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab (1.7% in the SUSVIMO arm vs 0.5% in the intravitreal arm). When including extension phases of clinical trials, 2% (11/555) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 5 and 853, with a median of 173 days. Many, but not all, of the cases of endophthalmitis reported a preceding or concurrent conjunctival retraction or erosion event. In the active comparator period of the controlled clinical trial in DME, 0% of patients in the SUSVIMO arm compared to 0.3% in the intravitreal arm experienced an episode of endophthalmitis. When including the extension phase of the clinical trial, 0.7% (4/556) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 625 and 1016, with a median of 824 days. In the period with an observational comparator arm of the clinical trial in DR, there were no patients (0/105) in the SUSVIMO arm who experienced an episode of endophthalmitis [see Clinical Studies (14.3) ] . When including the extension phase of the clinical trial 0.8% (1/128) patients receiving the ranibizumab implant experienced an episode of endophthalmitis, with the event reported on day 695. Endophthalmitis should be treated promptly in an effort to reduce the risk of vision loss and maximize recovery. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed until resolution of endophthalmitis [see Dosage and Administration (2.10) and Adverse Reactions (6.1) ] . Patients should not have an active or suspected ocular or periocular infection or severe systemic infection at the time of any SUSVIMO implant or refill procedure. Appropriate intraoperative handling followed by secure closure of the conjunctiva and Tenon's capsule, and early detection and surgical repair of conjunctival erosions or retractions and strict/controlled aseptic technique conditions throughout refill-exchange procedures may reduce the risk of endophthalmitis [see Dosage and Administration (2.1) and Warnings and Precautions (5.5) ] . 5.2 Rhegmatogenous Retinal Detachment Rhegmatogenous retinal detachments have occurred in clinical trials of SUSVIMO and may result in vision loss. Rhegmatogenous retinal detachments should be promptly treated with an intervention (e.g., pneumatic retinopexy, vitrectomy, or laser photocoagulation). SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the presence of a retinal detachment or retinal break [see Dosage and Administration (2.10) ] . Careful evaluation of the retinal periphery is recommended to be performed, and any suspected areas of abnormal vitreo-retinal adhesion or retinal breaks should be treated before inserting the implant in the eye. 5.3 Implant Dislocation In clinical trials, the device has dislocated/subluxated into the vitreous cavity or has extended outside the vitreous cavity into or beyond the subconjunctival space. Device dislocation requires urgent surgical intervention. Strict adherence to the scleral incision length and appropriate targeting of the pars plana during laser ablation may reduce the risk of implant dislocation. 5.4 Septum Dislodgement In clinical trials, a type of implant damage where the septum has dislodged into the implant body has been reported. Perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in the vitreous cavity through the pupil prior to and after the refill-exchange procedure to identify if septum dislodgement has occurred. Discontinue treatment with SUSVIMO (ranibizumab injection) following septum dislodgement and consider implant removal should the benefit of the removal procedure outweigh the risk [ see Dosage and Administration (2.9) ]. The benefits and risks of retaining, removing, or removing and replacing an implant with a dislodged septum are not well characterized. Appropriate handling and insertion of the refill needle into the septum (avoid twisting and/or rotation) is required to minimize the risk of septum dislodgement [ see Dosage and Administration (2.8) ]. 5.5 Vitreous Hemorrhage Vitreous hemorrhages may result in temporary vision loss. Vitrectomy may be needed in the case of a non-clearing vitreous hemorrhage [see Dosage and Administration (2.10) ] . In clinical trials of SUSVIMO including the extension phases in patients with AMD, vitreous hemorrhages were reported in 5.2% (23/443) of patients receiving SUSVIMO. In the clinical trial of SUSVIMO including the extension phases in patients with DME, vitreous hemorrhages were reported in 10.1% (56/556) of patients receiving SUSVIMO. In the clinical trial of SUSVIMO including the extension phase in patients with DR, vitreous hemorrhages were reported in 9.4% (12/128) of patients receiving SUSVIMO. The majority of these hemorrhages occurred within the first post-operative month following surgical implantation and the majority of vitreous hemorrhages resolved spontaneously. Patients on antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. Antithrombotic medications are recommended to be temporarily interrupted prior to the implant insertion procedure. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the event of sight-threatening vitreous hemorrhage. The use of pars plana laser ablation and scleral cauterization should be performed to reduce the risk of vitreous hemorrhage. 5.6 Conjunctival Erosion or Retraction A conjunctival erosion is a full thickness degradation or breakdown of the conjunctiva in the area of the implant flange. A conjunctival retraction is a recession or opening of the limbal and/or radial peritomy. Conjunctival erosions or retractions have been associated with an increased risk of endophthalmitis, especially if the implant becomes exposed. Surgical intervention (e.g., conjunctival/Tenon's capsule repair) is recommended to be performed in case of conjunctival erosion or retraction with or without exposure of the implant flange. In clinical trials of SUSVIMO including the extension phases in patients with AMD, 3.6% (16/443) of patients receiving SUSVIMO reported conjunctival erosion and 1.6% (7/443) of patients receiving SUSVIMO reported conjunctival retraction in the study eye. In the clinical trial of SUSVIMO including the extension phases of patients with DME, 2.2% (12/556) of patients receiving SUSVIMO reported conjunctival erosion and 1.3% (7/556) of patients receiving SUSVIMO reported conjunctival retraction in the study eye. In the clinical trial of SUSVIMO including the extension phase in patients with DR, 2.3% (3/128) of patients receiving SUSVIMO reported conjunctival erosion and 1.6% (2/128) of patients receiving SUSVIMO reported conjunctival retraction in the study eye. Appropriate intraoperative handling of conjunctiva and Tenon's capsule to preserve tissue integrity and secure closure of peritomy while ensuring placement of sutures away from implant edge may reduce the risk of conjunctival erosion or retraction. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion. 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 the extension phases in patients with AMD, 5.9% (26/443) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye. In the clinical trial of SUSVIMO including the extension phases in patients with DME, 9% (50/556) of patients receiving SUSVIMO reported conjunctival bleb/conjunctival filtering bleb leak in the study eye. In the clinical trial of SUSVIMO including the extension phase in patients with DR, 3.9% (5/128) 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 in patients with AMD [see Clinical Studies (14.1) ] . Visual acuity was decreased by 7 letters on average in the first postoperative month and 3 to 4 letters on average in the second postoperative month following initial implantation of SUSVIMO in patients with DME and DR [see Clinical Studies (14.2 and 14.3) ] . 5.9 Postoperative Intraocular Inflammation Postoperative intraocular inflammation has occurred following SUSVIMO implantation. The majority of cases occurred during the first week following implantation and resolved within the first month. 5.10 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. 5.11 Deflection or Movement of the Implant Use caution when performing ophthalmic procedures (e.g., B-scan ophthalmic ultrasound, scleral depression, or gonioscopy) that may cause deflection or movement of the implant and subsequent injury.