Stability and efficacy studies
A significant amount of effort is necessary to obtain protein stability and functional data from animal models. Protein stability may be lost in formulations meant to last for 2-3 months. One potential advantage of the PK-Eye™ is the ease to evaluate protein properties such as stability and functionality.
Animals also quickly develop anti-drug antibodies (ADAs), which is an intractable problem that negatively impacts the preclinical development of long lasting dosage forms or devices for ocular use.
Preliminary stability study of bevacizumab injection (1.25 mg, 50 uL) in the PK-Eye™