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warnings and cautions
5 WARNINGS AND PRECAUTIONS ENCELTO implantation has been associated with severe vision loss, infectious endophthalmitis, retinal tears and/or detachment, vitreous hemorrhage, implant extrusion, cataract formation, suture related complications, and delayed dark adaptation. 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 , 5.8 ) Vitreous Hemorrhage: Temporarily discontinue antithrombotic medication prior to ENCELTO insertion surgery to reduce the risk of implantation related vitreous hemorrhage. Vitreous hemorrhages occurring greater than one year from implantation could be a sign of ENCELTO extrusion. The surgical site should be examined closely and the ENCELTO should be surgically repositioned if indicated. ( 5.4 ) 5.1 Severe Vision Loss Severe vision loss defined as three or more lines of visual acuity loss [≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. Monitor patients for signs and symptoms of vision loss and manage as clinically indicated. 5.2 Infectious Endophthalmitis Infectious endophthalmitis may occur following ENCELTO implantation. Signs and symptoms of infectious endophthalmitis include progressively worsening eye pain, vision loss, or scleral and conjunctival injection. To mitigate the risk of endophthalmitis, use proper aseptic surgical technique for ENCELTO implantation [ see Dosage and Administration (2.2) ]. Monitor patients for signs or symptoms of infectious endophthalmitis. Remove ENCELTO implant if infectious endophthalmitis occurs and manage symptoms according to clinical practice. 5.3 Retinal Tear and Detachment Retinal tears and retinal detachment may occur following ENCELTO implantation. Signs and symptoms of retinal tears include acute onset of flashing lights, floaters, and/or loss of visual acuity. Signs and symptoms of retinal detachment may include progressive visual field loss and/or loss of visual acuity. Use standard vitreoretinal surgical techniques during ENCELTO implantation to minimize the risk of retinal tears and retinal detachment. Monitor for any signs or symptoms of retinal tear and/or retinal detachment. Treat rhegmatogenous retinal detachment and retinal tears promptly. Remove ENCELTO implant, if vitrectomy with a complete gas fill or silicone oil fill is required [ see Dosage and Administration (2.3) ]. 5.4 Vitreous Hemorrhage Vitreous hemorrhage, which may result in temporary vision loss, has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. Patients receiving antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. To reduce the risk of vitreous hemorrhage, interrupt antithrombotic medications prior to the ENCELTO implantation. Vitrectomy surgery may be necessary to clear severe, recurrent, or non-clearing vitreous hemorrhage. If the patient has a late onset vitreous hemorrhage (greater than one year following ENCELTO implantation surgery), examine the ENCELTO implantation site for possible implant extrusion. If implant extrusion has occurred, surgically reposition ENCELTO [ see Implant Extrusion (5.5) ]. 5.5 Implant Extrusion Implant extrusion through the initial scleral wound has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. Signs and symptoms of implant extrusion include recurrent uveitis, vitreous hemorrhage, eye pain more than one year after implantation, or visibility of titanium fixation loop under the conjunctiva. To reduce the risk of implant extrusion, carefully follow the specific surgical steps for ENCELTO implantation [ see Dosage and Administration (2.2) ]. Evaluate patients after 6 months to confirm proper positioning of ENCELTO and then annually. If ENCELTO begins to extrude, surgically reposition ENCELTO to a proper scleral wound depth either in the same site or in the opposing inferior quadrant of the vitreous cavity. 5.6 Cataract Formation Cataract formation, including cataract cortical, cataract nuclear, cataract subcapsular, cataract traumatic, and lenticular opacities, has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. To reduce the risk of ENCELTO-related cataract formation or progression, carefully follow the specific surgical steps for ENCELTO implantation [ see Dosage and Administration (2.2) ]. 5.7 Suture Related Complications Suture related complications, including conjunctival erosions due to suture tips and suture knots, have occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. To mitigate the risk of suture related complications, carefully follow the specific surgical steps for ENCELTO implantation [ see Dosage and Administration (2.2) ] and manage suture-related complications as clinically indicated. 5.8 Delayed Dark Adaptation Delayed Dark Adaptation, a delay in the ability to adjust vision from a bright lighting condition to a dim lighting, has occurred following ENCELTO administration which remained unchanged for the duration of study follow up [ see Adverse Reactions (6) ]. Advise patients to take caution while driving and navigating in the dark.
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥2%) were conjunctival hemorrhage, delayed dark adaptation, foreign body sensation, eye pain, suture related complications, miosis, conjunctival hyperemia, eye pruritus, ocular discomfort, vitreous hemorrhage, blurred vision, headache, dry eye, eye irritation, cataract progression or formation, vitreous floaters, severe vision loss, eye discharge, anterior chamber cell, iridocyclitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurotech at 1- 833-963-9275 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to ENCELTO in two clinical trials, Study 1 (NTMT-03-A) and Study 2 (NTMT-03-B) and are pooled for analysis. A total of 117 patients received ENCELTO, and 111 patients underwent a sham procedure and were followed for a duration of 24 months [ see Clinical Studies (14) ]. Serious adverse reactions occurred in six patients (5%) including suture related complications (n=5) and implant extrusion (n=1). Table 1 lists the most common adverse reactions that occurred in > 2% patients and with higher frequency in ENCELTO group compared to Sham group in Study 1 and Study 2. Table 1. Adverse Reactions occurring in ≥2% of Patients and with higher frequency in ENCELTO group compared to Sham group in ENCELTO studies* Adverse Reactions ENCELTO (N=117) n (%) Sham (N=111) n (%) Conjunctival hemorrhage 36 (31) 29 (26) Delayed dark adaptation 27 (23.1) 1 (1) Foreign body sensation in eyes 18 (15) 15 (13.5) Eye pain 18 (15) 10 (9) Suture related complication** 18 (15.4) 3 (2.7) Miosis 18 (15.4) 0 (0.0) Conjunctival hyperemia 13 (11) 9 (8) Eye pruritus 10 (9) 4 (3.6) Ocular discomfort 10 (9) 1 (1) Vitreous hemorrhage 10 (8.5) 0 (0.0) Vision blurred 8 (7) 4 (4) Headache 8 (7) 1 (1) Dry eye 7 (6) 2 (2) Eye irritation 6 (5.1) 2 (2) Cumulative cataract incidence 6 (5) 0 (0) Vitreous floaters 6 (5) 0 (0.0) Severe visual loss>15 letters*** 4 (3) 0 (0) Eye discharge 4 (3.4) 1 (0.9) Anterior chamber cell 4 (3.4) 0 (0.0) Iridocyclitis 3 (2.6) 0 (0) * Pooled data from Study 1 and Study 2; Adverse reaction rates were comparable between the two studies **Suture related complications include exposed suture, foreign body sensation, conjunctival wound dehiscence, painful sutures, suture irritation, suture granuloma, scleral wound opening, and itchy suture *** Includes one case of visual loss due to cataract formation which remained unresolved at the end of the study