Ocular PK Studies

As experts in ocular pharmacology and ocular dosing of preclinical laboratory species, Experimentica specializes in the in-life component for non-GLP PK studies in rodents, rabbits and minipig. Our laboratory sites in Europe and the United States can accommodate anything from small pilot investigations to large scale studies.

Using our network of bioanalytical CROs, our dedicated PK study teams can help identify partners for bioanalytical analysis and perform PK analysis.

Available species for PK studies:

  • Mouse, rat
  • Rabbit (Dutch Belted, New Zealand White)
  • Guinea pig
  • Minipig, pig

Established dosing routes:

  • Intravitreal
  • Subretinal
  • Suprachoroidal
  • Intracameral
  • Periocular
  • Intravenous, IV; intraperitoneal, IP; intramuscular, IM
  • Topical
  • Per os

Ocular Pharmacokinetic studies

Pharmacokinetics (PK) examines how drugs are absorbed, distributed, metabolized, and eliminated by the body over time and at different dosage levels. Therefore, PK analyses are important for determining dosing regimens to achieve efficacy and evaluating safety – for both preclinical efficacy studies and design of subsequent first-in-human trials. Importantly, non-GLP PK studies can be combined with early safety readouts to de-risk pre-IND efficacy and IND-enabling safety pharmacology studies.

Experimentica has the expertise, precision, and attention to detail to conduct thorough PK analyses and tailor them to meet the specific needs of study sponsors.

Ocular PK studies can extend to pathological conditions in preclinical models for ophthalmic disease to obtain pharmacodynamic/pharmacokinetic (PD/PK) readouts, providing information on drug absorption and elimination during disease.

Our Teams are skilled in administering a wide range of test articles and test article formulations, ranging from small molecules in aqueous formulations to sustained-release implants and gene therapy.

We have experience administrating numerous types of drug classes and formulations:

  • Solutions, suspensions, emulsions
  • Nanoparticle formulations
  • Gene therapy vectors (adeno-associated virus, AAV and lentivirus, LV)
  • Medical devices, such as ocular implants and contact lenses
  • Devices for systemic delivery, such osmotic pumps, and patches

Our formulation laboratory can prepare most drug formulations extemporaneously; at this point Experimentica specializes in formulation testing, but does not offer formulation development services.

Dosage volumes and routes of administration

Ocular administration of test articles requires the careful evaluation of dosing volumes to achieve appropriate dilution in ocular fluids and to avoid delivery-associated complications. The table below summarizes the recommended dosing volumes for common ocular drug delivery routes for the most-frequently used preclinical laboratory species at Experimentica.

This table summarizes the recommended dosing volumes for common ocular drug delivery routes for the most-frequently used preclinical laboratory species at Experimentica.
Table 1. Typical dosing volumes for ocular drug delivery.

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Ocular sub-tissue collection

PK studies must consider the type and amount of ocular sub-tissues that can be collected from the various preclinical laboratory animal species. At Experimentica, our scientific teams are skilled in performing microdissections and we can advise on species selection based on anatomical considerations, disease indication and mechanism of action.

The type and weights of ocular sub-tissues that can be isolated from various laboratory species is largely determined by the size of the eye and are summarized below.

Type of ocular sub-tissues that can be isolated from various laboratory species.
Table 2. Ocular sub-tissues typically collected for ocular PK studies. RPE/choroid are typically collected together with the sclera, however, can be scraped from the sclera, if needed. ** Collection is not recommended, typical collection volume <5 µL. *** RPE can be separated from choroid in pigmented animals (e.g. Dutch Belted rabbits), but not albinos (e.g. New Zealand White rabbits).
Table 3. Ocular sub-tissue weight and volumes. * In rodents, RPE/choroid is typically collected together with sclera and weight indicated is RPE/choroid combined with sclera.

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Animals and Species used for PK Studies

All animals studies are conducted in accordance with the ARVO Statement for the Use of Animals in Ophthalmic and Vision Research, and follow guidelines set forth by the Guide for the Use and Care of Laboratory Animals and EC Directive 2010/63/EU for animal experiments. All protocols are approved and monitored by the local IACUC or state governing body.

Experimentica’s Global Animal Welfare Board comprised of scientists and veterinarians continuously reviews and monitors all activities involving preclinical laboratory species and makes recommendations for modifications and improvements in accordance with the principles of refinement, reduction and replacement (3R).