Tolerability of Ocular Buffers Utilized to Deliver Cell and Gene Therapies into the Posterior Segment of the Eye

Poster Authors:
Sandeep Kumar, Xiaohui Zhang, Sudan Puri, James Lee, Hannah Gill, Yesica Chaparro, Vivian Trenti, Stephanie Peters, Jenny Walters, Walter Collette, Sara Mangosing, Carly Boyd, Sujata Rijal, Manindra Singh, Glenwood Gum
Ophthalmology, Pharmaron US Lab Services, San Diego, CA, United States.
This study assessed ocular buffer tolerability by evaluating the in vivo safety of various buffer formulations used for intravitreal (IVT) and subretinal (SR) injections in support of cell and gene therapy development for retinal diseases.
Highlights from our ocular buffer tolerability poster:?
- Delivery validation: OCT/fundus imaging confirmed successful IVT and SR delivery of buffers in both RNU rats and C57BL/6 mice.?
- Well-tolerated formulations: Most buffers, including BSS and BSS Plus, showed normal retinal structure and function at Day 30.?
- Exceptions noted:?
- BSS with 0.1% human albumin caused mild to moderate vitreous inflammation in both IVT and SR injections.?
- DMSO (1% and 5%) led to dose-dependent retinal toxicity when delivered via SR, but not IVT, as confirmed by ERG.?
Takeaway: Most ocular buffers are well tolerated, but formulations containing DMSO or albumin may induce toxicity. SR delivery routes should avoid DMSO, and real-time imaging should be used to confirm proper administration.