Preclinical testing of innovative therapeutics for ocular diseases, including age-related macular degeneration (AMD), diabetic retinopathy, glaucoma, dry eye disease, retinal disorders and corneal diseases, requires specific expertise. Preclinical ophthalmology research combines relevant ocular disease models, specialized drug administration techniques and advanced efficacy assessments to characterize the pharmacological activity, therapeutic potential and safety of experimental therapies.
OncoBone provides preclinical expertise to support study planning, model selection, protocol development, study execution, data interpretation and reporting for your ophthalmology drug development programs. Our flexible approach through the Virtual CRO service allows us to design integrated studies around your specific needs and objectives. Such objectives can include information about efficacy, pharmacokinetics, pharmacodynamics, ocular drug distribution, target engagement, biomarkers and/or safety and tolerability.
Why are preclinical ophthalmology studies needed?
Preclinical ophthalmology studies help answer important questions during early-stage drug development such as:
- What is the therapeutic activity in relevant ocular disease models
- How treatment affects ocular structures and visual function
- What drug exposure is achieved in ocular tissues
- What potential safety risks may emerge following administration
If you are unsure about which ocular disease model(s) or study approach is most appropriate for your program, continue reading and contact us at info@oncobone.com to discuss your preclinical evaluation strategies.
Ophthalmology study capabilities
We have access to more than 70 ocular disease models including:
- Age-related macular degeneration (AMD) and geographic atrophy
- Diabetic retinopathy
- Glaucoma
- Dry eye disease
- Retinal disorders
- Corneal diseases
- Ocular inflammation
The models are not enough to study the efficacy of your experimental therapy. We have a number of advanced measurements and evaluations available for providing reliable results. Possible efficacy assessments include:
- Optical coherence tomography (OCT)
- Electroretinography (ERG)
- Fundus imaging
- Intraocular pressure (IOP) measurements
- Visual function assessments
- Histological and morphological evaluations
Combining different methods helps to characterize effects of your experimental therapy on ocular structures and function.
Ocular Pharmacokinetics and Drug Delivery (PK/PD)
The objective is to characterize drug exposure, distribution and pharmacological response following ocular administration, helping to evaluate the relationship between dose, exposure and biological effect.
First phase of a PK/PD study is administration. We have extensive experience in intravitreal injection, subretinal injection, suprachoroidal injection, intracameral injection and other relevant administration approaches depending on study objectives.
A PK/PD study with one of the above-mentioned administrations can help you to assess:
- Ocular pharmacokinetic profiling
- Ocular tissue distribution and drug exposure assessment
- Pharmacodynamic evaluations
- Assessment of different ocular administration routes
- Dose–response characterization
- PK/PD analysis
Ocular Safety and Tolerability
Integrating safety assessments with efficacy and pharmacokinetic studies can provide a more comprehensive understanding of the experimental therapy, providing valuable information for upcoming safety studies. Safety and tolerability assessments can include:
- Safety and tolerability evaluations by clinical observations and ophthalmic examinations
- Intraocular pressure measurements
- Ocular imaging and functional assessments
- Histopathology and tissue evaluations with specialized pathology assessments
Why work with OncoBone?
The development of new ophthalmic treatments increasingly involves advanced therapeutic approaches that require specialized preclinical evaluation. Successful preclinical drug development requires appropriate scientific expertise, relevant disease models, reliable data generation, attention to animal welfare, and high standards of research quality. When selecting a preclinical CRO partner, it is important to consider the availability of specialized ocular disease models, experience with different administration routes, advanced imaging and functional assessment technologies, and the ability to integrate efficacy, PK/PD and safety evaluations.
OncoBone assists you by proving a tailored study design, transparent communication and comprehensive data reporting to help you ensure that research findings provide meaningful information to support drug development decisions when moving forward to later-stage development.
If you are interested in learning more about preclinical ophthalmology research capabilities or discussing your upcoming study requirements, please contact us at info@oncobone.com.
