Preclinical ophthalmology expertise
Ocular models
Investigation of ocular diseases using established in vitro and in vivo preclinical models (i.e., mice, rat and/or rabbits), including:
- Wet AMD – e.g., CNV, OIR
- Dry AMD – e.g., NaIO₃, light-induced retinal degeneration
- Diabetic Macular Edema – e.g., STZ-induced, Akimba models
- Glaucoma – e.g., optic nerve crush
- Trabeculectomy – surgical models for assessing anti-fibrotic therapies
These studies enable the evaluation of disease mechanisms, efficacy of treatments, and potential therapeutic interventions.
Specialized procedures
Expert handling and administration of compounds, along with precise collection and analysis of biological samples, including:
- Compound Administration – e.g., IVT, SCJ, IC, IP, IV, SQ and other routes
- Tissue and Blood Sampling – collection and processing of ocular and systemic samples for pharmacokinetic, pharmacodynamic, and biomarker analyses
- Histology & Imaging - tissue processing and analysis of ocular tissue samples with techniques like histology, immunofluorescence and fluorescent imaging to understand the effects of a treatment.
These specialized techniques ensure accurate dosing, reliable data, and robust study outcomes.
Ocular assessments
Comprehensive evaluation of relevant endpoints (e.g., angiogenesis, leakage, inflammation), eye structure and function using advanced imaging and diagnostic technique, including:
- Ocular Coherence Tomography (OCT) – high-resolution retinal imaging
- Fundus Imaging – visualization of the retina and posterior segment
- Electroretinography (ERG) – measurement of retinal electrical activity
- Indirect Ophthalmoscopy – detailed examination of the retina
- Slit Lamp Examination – assessment of anterior segment structures
- Tonometry – intraocular pressure (IOP) assessment
These assessments provide essential insights into ocular health, disease progression, and treatment efficacy.
Pharmacokinetic studies
Comprehensive pharmacokinetic evaluations in rodents and rabbits to characterize the absorption, distribution, metabolism, and elimination of therapeutic candidates, including:
- Bioanalytical Sampling – systematic collection of blood, ocular tissues, and fluids for exposure profiling
- Ocular vs. Systemic PK – local versus systemic delivery routes
- PK/PD Correlation – integration of pharmacokinetic data with pharmacodynamic or efficacy endpoints
These studies provide essential insight into dose selection, delivery optimization, and therapeutic feasibility.
Tolerability & safety studies
Evaluation of ocular and systemic tolerability/safety profiles in rodents and rabbits to support preclinical development and regulatory submissions. Tolerability/safety assessments include:
- Local and Systemic Tolerability – monitoring of injection sites, ocular tissues, and systemic responses
- Clinical Observations – regular assessment of behavior, body weight, and general health
- Ocular Examinations – slit lamp, fundus imaging, OCT, and IOP measurements to detect structural or functional changes
These studies identify potential ocular and systemic adverse effects, and support progression toward GLP toxicology studies.
GLP toxicology support
Scientific guidance and oversight for planning and interpreting GLP-compliant toxicology programs (according to ICH guidelines), including:
- Study Design – support of protocols for single-dose, repeat-dose, chronic, reproductive, and specialty toxicology studies
- Protocol & Data Review – high-level review of study protocols, interim data, and final GLP reports to ensure quality, traceability, and regulatory readiness
- Regulatory Alignment – ensuring study designs and documentation meet global requirements for IND/CTA submissions
These studies establish the safety margin, identify potential tox effects, and support progression toward first-in-human trials.