encelto (revakinagene taroretcel-lwey) · Neurotech Pharmaceuticals Inc.

The efficacy of ENCELTO was evaluated in two studies, Study NTMT-03-A ( NCT03316300 ; Study 1) and Study NTMT-03-B ( NCT03319849 ; Study 2) as described below.

Study 1Study 1 was a randomized, multi-center, sham-controlled study which enrolled adults with MacTel. For enrollment, the patients were required to have a photoreceptor inner segment/outer segment (IS/OS PR) break (loss) in ellipsoid zone (EZ) between 0.16 and 2.00 mm 2 measured by spectral domain-optical coherence tomography (SD-OCT) and best corrected visual acuity (BCVA) of 54-letter score or better (20/80 or better) as measured b...

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...

ENCELTO is contraindicated in patients with: Active or suspected ocular or periocular infections. Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM) Ocular or periocular infections. ( 4 ) Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM). ( 4 )

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: Temp...