Summary: Small scale non-GLP toxicity and tolerability studies are a cost-effective approach to generate early data with your drug candidate.
Before you proceed with a complete GLP program for your drug candidate, consider running a small scale non-GLP toxicity and tolerability study. This is a more cost-effective approach specifically if no prior information is available.
The follow-up time might vary from 4 weeks to 3 months.
Routes of compound administration: topical, intravitreal, intracameral, subconjuctival, subretinal, systemic.
Outcomes and capabilities
Macroscopic and clinical examinations
We offer daily macroscopic examinations as well as weekly ophthalmic evaluation for any signs of irritation, inflammation in the anterior part of the eye as well as at the back side (e.g. Draize scoring).
Intraocular pressure assessment
Using TonoLab tonometer for rodents and TonoVet for rabbits (Kalesnykas & Uusitalo, 2007).
In vivo imaging
Our capabilities include fundus imaging, fluorescein angiography (Heidelberg Spectralis, Heidelberg Engineering), spectral-domain optical coherence tomography (SD-OCT, Envisu R2200 and R2210, Bioptigen/Leica Microsystems), optical coherence tomography-angiography (OCT-A, Heidelberg Engineering).
Electroretinography is used to assess functionality of retinal cells.
Tissue collection and pathological evaluation:
Aqueous humor, vitreous, and different parts of the eye can be collected upon request.
- Kalesnykas G & Uusitalo H (2007) Comparison of simultaneous readings of intraocular pressure in rabbits using Perkins handheld, Tono-Pen XL, and TonoVet tonometers. Graefes Arch Clin Exp Ophthalmol 245:761-762.
- FDA guidance documents for nonclinical safety studies