Service Overview

Ace Therapeutics, a comprehensive preclinical ophthalmology CRO, is able to conduct safety and efficacy assessments for all ophthalmic indications. Here, we are pleased to support your ophthalmic product development by offering pupil diameter testing services.

Our pupil diameter testing services are designed to help you collect valuable data on ophthalmic products' safety, pharmacokinetics, efficacy, and action. This information supports the development and optimization of compounds for the treatment of ocular diseases. As part of ocular tolerability and safety assessments, pupil diameter involves administering a small amount of a potential compound to the eye of a model (rabbit, dog, mouse, minipig, etc.) and observing the compound's effect on pupil diameter to predict the efficacy or possible ocular side effects of your product.

Access Ace Therapeutics' Pupil Diameter Test of Ophthalmic Compounds

Ace Therapeutics performs pupil diameter tests to assess the effect of potential candidate compounds on pupil diameter in rabbits using the following protocol.

• Experiment Procedure

• Eye examination of the test animals (albino rabbits): Before the test, the animals should adapt to the animal laboratory environment for at least 3 days. 24 hours before the trial, both eyes of the experimental animals should be thoroughly examined. Animals with corneal defects or conjunctival lesions with eye irritation symptoms should not be used.
• Groups: 9 albino rabbits were divided into three groups, including the test product group, the vehicle (when applicable) group, and the control substance (pilocarpine or atropine) group.
• Administration: Gently hold the rabbit's eyelids open using an ophthalmic speculum or a cotton swab, ensuring the rabbit's eye is exposed. Carefully instill the ophthalmic compound or test solution into the conjunctival sac of the rabbit's eye, following the recommended dosage and instructions. (Topical, iontophoresis…)
• Evaluation: Pupil diameters were measured using a pupillometer before and at specific time intervals after instilling the compound. Statistical analysis of the data obtained and referenced to the measurement in millimeters versus time was performed to identify any significant changes in pupil diameter caused by the ophthalmic compound. The test results are compared to an appropriate control group to assess the compound's effect.
• Repeat the test: If necessary, the experiment will be repeated with the same or different compounds to validate the results or evaluate dose-dependent effects.
• Guidelines: Guideline on non-clinical local tolerance testing of medicinal products - EMA/CHMP/SWP/2145/2000 Rev. 1 Corr.

Note*: Ace Therapeutics' pupil diameter test can be adjusted to meet specific requirements according to the characteristics of your product, such as structural characteristics, physicochemical properties, indication characteristics, and test purposes. Importantly, our talented scientists will also conduct a comprehensive evaluation of the test results in combination with other pharmacological and toxicological information to help you reduce asset risks before entering IND-supported studies.

What Problems Can We Solve?

• Safety and tolerability assessment: Some ophthalmic compounds may affect the size of the pupil, which could potentially cause adverse effects. By measuring the changes in pupil diameter of your ophthalmic products, our scientists can determine the safety and tolerability of these compounds. Additionally, unintended changes in pupil size could indicate unwanted side effects.
• Pharmacokinetics evaluation: The pupil diameter test helps in evaluating the pharmacokinetics, or the movement of the drug within the body, of ophthalmic compounds. It can provide information about your ophthalmic products' absorption, distribution, metabolism, and elimination.
• Assessment of drug efficacy: Certain ophthalmic conditions, such as glaucoma, may be associated with abnormal pupil responses. By measuring and analyzing pupil diameter, our scientists can assess the effectiveness of ophthalmic compounds in treating these conditions. The test can help you determine if your drug is able to restore normal pupil reactions.
• Understanding mechanisms of action: Pupillary responses are controlled by the autonomic nervous system, which is responsible for regulating unconscious bodily functions. Through our pupil diameter test, you can gain insights into the mechanisms of action of your ophthalmic compounds. This information aids in understanding how the drug interacts with specific receptors and neural pathways.

Ace Therapeutics' pupil diameter test services are designed to support the development and optimization of customers' products for the treatment of ocular diseases. 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!

• Acute Local Toxicity Testing of Ophthalmic Drugs
• Chronic Local Toxicity Testing of Ophthalmic Drugs
• Maximum Tolerated Dose (MTD) Testing of Ophthalmic Drugs
• Lacrimation Testing of Ophthalmic Drugs
• Corneal Anesthesia Testing of Ophthalmic Drugs

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