Safety Assessment Of Intravitreal Implants In Dutch Belted Rabbits

To support their IND, a client engaged Altasciences to conduct a chronic toxicology study evaluating the ocular safety of a cylindrical intravitreal implant loaded with an API for the treatment of age-related macular degeneration. Dutch Belted (DB) rabbits were selected as the animal model due to their historical use in ocular safety studies, the need for pigmented eyes to assess ocular melanin binding potential, and their availability in sufficient numbers for an IND-enabling study.
The study required administering doses several-fold higher than the human equivalent, necessitating up to six implants per eye. This posed both technical and scientific challenges, given the smaller vitreous volume (~1.5 mL in rabbits vs. ~5 mL in humans) and larger lens size (~8 mm in rabbits vs. ~4 mm in humans). These anatomical differences increased the risk of implant contact with the posterior segment's soft tissues during and after injection.
To address this, the study design incorporated specific measures to identify, monitor, and distinguish any lesions caused by the dosing procedure from those associated with the API itself, ensuring accurate and reliable safety data.
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