Importance of Ocular Toxicology Study

Ocular toxicology studies are those that affect one or more adverse changes in the structure or function of the eye following the administration of a substance, drug, or device directly to or in the eye or to other parts of the body remotely from the eye.  These types of studies follow specific regulatory guidelines. In the most severe cases, ocular toxicity may result in eye pain and/or irreversible vision loss. Through ocular toxicology studies, researchers are able to assess the potential ocular side effects of new drugs and ensure that these drugs are safe and effective for patients. In addition, research in ocular toxicology contributes to the development of new treatments and interventions for various ocular conditions and diseases. Researchers can develop targeted therapies to minimize toxicity and optimize treatment outcomes by understanding the toxicological pathways involved in eye damage. Overall the development of any ophthalmic product needs preclinical ocular toxicology studies to meet regulatory requirements and better enter the IND pathway.

Service Overview

Ace Therapeutics is a preclinical biological company specializing in ocular toxicology research. Our team of experienced ophthalmic toxicology experts conducts ocular tolerance and safety studies on preclinical experimental animals to evaluate the tolerability and potential toxicity of your ophthalmic products to the eyes. As an extension of your team, our scientists and technicians help you accelerate your research goals and ensure your preclinical drug development program delivers high-quality data for critical decision-making.

At Ace Therapeutics, we offer a full range of complementary services to support ocular tolerability and safety studies, such as clinical assessment (ophthalmological examination), imaging and electrophysiological assessment of the visual system, histopathological assessment, and systemic and other organ-specific assessments.

The typical design of our ocular toxicology studies includes assessment of acute, subacute, and chronic local toxicity, determination of the maximum tolerated dose (MTD), and testing of ocular tolerability. All study designs can be tailored to meet specific requirements or to reduce asset risk prior to entering an IND-supported study.

Most of the research needed for your IND initiation plan can be performed at Ace Therapeutics!

Access Ace Therapeutics' Ocular Toxicology Study

It is worth mentioning that our local tolerance studies in animal models can be conducted independently or as part of other toxicity studies. With many years of expertise in this field, Ace Therapeutics is happy to be your trusted partner in ophthalmic drug safety assessment.

What Species do We Work With?

• Mouse
• Rat
• Guinea Pig
• Rabbit
• Canine
• Pig
• Mining pig
• Non-human primate (NHP)

Our Routes of Administration

• Intravitreal
• Intracameral
• Subconjunctival/tenons
• Subretinal
• Topical
• Systemic

Advantages of Ace Therapeutics' Ocular Toxicology Study

• Individualized study design to meet partners' unique needs and regulatory requirements.
• Experienced ophthalmic toxicology specialist personnel with the most advanced technology.
• Provide technical advice and support throughout the study results interpretation.
• Study design based on the latest guidelines.

With strong professional knowledge and an advanced technology platform, Ace Therapeutics provides comprehensive ocular toxicology services. Our professional ocular toxicology study team will evaluate your ophthalmic products by flexibly designing a variety of typical tests according to your project needs. If you are interested in our services or need more detailed information, please feel free to contact us. Our experienced scientists are ready to help you!

References

1. Onodera H, Sasaki S, Otake S, et al. General considerations in ocular toxicity risk assessment from the toxicologists' viewpoints. J Toxicol Sci. 2015, 40(3):295-307.
2. Wilson SL, Ahearne M, Hopkinson A. An overview of current techniques for ocular toxicity testing. Toxicology. 2015, 327:32-46.

• Ocular Pharmacology Services
• Ocular Pharmacokinetic Services
• Ocular Histology and Histopathology Services
• Customized Non-GLP Ophthalmic Program Development Services
• Customized Services for Ocular Drug Delivery System Development

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