Encelto (Revakinagene Taroretcel-lwey)

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 . Monitor patients for signs and symptoms of vision loss and manage as clinically indicated.

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.

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.

Vitreous Hemorrhage: Vitreous hemorrhage, which may result in temporary vision loss, has occurred following ENCELTO implantation . Patients receiving antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage.

Implant Extrusion: Implant extrusion through the initial scleral wound has occurred following ENCELTO implantation . 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.

Cataract Formation: Cataract formation, including cataract cortical, cataract nuclear, cataract subcapsular, cataract traumatic, and lenticular opacities, has occurred following ENCELTO implantation .