Abstract
Purpose :
The NT-501 Implant uses Neurotech’s encapsulated cell technology to provide a long-term intraocular drug delivery to the retina for treatment of Macular Telangiectasia. Due to the expected long-term duration the NT-501 implant will be exposed to an aqueous environment in vivo, the hydrolytic stability as well as seal integrity needed to be evaluated. Therefore, a stability study was performed to evaluate the seal integrity and hydrolytic stability of the NT-501 capsule using a one-year real time and a two-year accelerated aging model.
Methods :
Real time and accelerated aging in a simulated in vivo condition (0.9% Saline Solution) was performed on the NT-501 capsule, the UV-cured adhesive, and the polyethersulfone/polyvinyl pyrrolidone (PES/PVP) hollow fiber membrane (HFM).
The integrity of the NT-501 capsules were evaluated quantitatively using both pressure-decay leak testing and an HPLC-MS method for detecting the adhesive degradant molecule 4-4’-methylenebis(cyclohexylamine) (HMDA), and morphologically by H&E staining. The NT-501 capsule was also evaluated using tensile strength. The bulk properties of the PES/PVP HFM was evaluated by FTIR, liquid liquid porometry, and GPC. The bulk properties of the UV-cured adhesive was evaluated by water uptake and mass loss.
Results :
The NT-501 capsule remained integral throughout the entire study and no substantial decrease in tensile strength was detected. No substantial changes were detected in the bulk properties of the PES/PVP HFM or the UV-cured adhesive.
Conclusions :
The stability study supports that the NT-501 capsule remains integral throughout the intended implant period of two years.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.