Ocular Studies

Ocular studies include acute irritation, ocular distribution (pharmacokinetics and pharmacodynamics – PK/PD), acute and repeat dose toxicity, implantation, drug screening and drug efficacy.

Customized ocular studies for targeted therapeutics.

Toxikon is focused on evaluating the safety and toxicity of biologics, pharmaceuticals and medical devices. Our experienced study directors will provide you with the expertise in ophthalmology models and endpoints for your ocular drug and device programs.

  • Ophthalmic drug discovery
  • Ophthalmic device and implantation
  • Ophthalmic safety and toxicity
  • Screening of neuroprotective/ gene therapy compounds
  • Development of ophthalmic disease models
  • Allergic conjunctivitis
  • Dry eye / Dry Eye Syndrome (DES)
  • Uveitis: EIU (endotoxin-induced uveitis) and EAU (experimental autoimmune uveitis)
  • Corneal Neovascularization (CoNV)
  • Lens opacity / cataracts
  • Glaucoma / Ocular Hypertension (OHT)
  • Choroidal Neovascularization (CNV)
  • Retinal Neovascularization (CNV)/ Retinopathy of Prematurity (ROP) / Oxygen Induced Retinopathy (OIR)
  • Subretinal Fibrosis
  • Diabetic Retinopathy (DR)
  • Proliferative Vitreoretinopathy (PVR)

As part of our extensive custom research and testing portfolio for ophthalmic discovery, we offer a variety of preclinical services, including the screening of neuroprotective compounds and creation of animal models for glaucoma research.

Ophthalmic Technique Capabilities

  • Ophthalmic Examination
  • Intraocular Pressure Measurement
  • Photography of the eye
  • Electroretinography (ERG) / Pattern ERG (pERG) / Visual Evoked Potential (VEP)
  • Fundus Fluorescein Angiography (FFA)
  • Spectral Domain Optical Coherence Tomography (SD-OCT)
  • Pupil measurement
  • Corneal Sensitivity Measurement
  • Corneal Thickness Measurement
  • Laser photocoagulation
  • Tear break-up time / tear production measurement
  • Stereo microscopy / ocular tissue dissection / retina and choroid dissection for flat-mounting
  • Immunohistochemistry (IHC) /Immunohistofluorescence (IHF)
  • Fluorescent microscopy / confocal microscopy Qimaging / Image J
  • Subconjuctival / intracameral / intravitreal / subretinal / episcleral vein injections / footpad / super space of choroid injections
  • Intraocular lens (IOL) surgery
  • Cauterizations of episcleral veins of Meibomian Gland Orifices

Ophthalmic Development Capabilities

  • Ocular examinations (anterior / posterior segments)
    • Combined Draize and McDonald-Shadduck scoring systems
    • Ocular posterior segment scoring scale
    • Slit-lamp, direct, and indirect ophthalmoscopy
  • Corneal sensitivity measurements
    • LUNEAU Cochet-Bonnet aesthesiometry
  • Corneal thickness measurement
    • Reichert pachymetry
  • Pupillary response assessment
    • NEUROPTICS Pupillometry PLR-100
  • Electroretinography (ERG) / Pattern ERG (pERG) / Visual Evoked Potential (VEP)
    • Espion E2 system (full-field ERG)
    • Celeris system (pERG/VEP)
  • Photography / fluorescein / videography (anterior / posterior segments and fundus)
    • Topcon fundus / slit lamp imaging systems
    • Carl Zeiss capture HD (1080P) video & movie systems
  • Laser photocoagulation
    • IRIDEX OcuLightÒ GL/G/X/TX (532µm), IQ 810 (810µm)
  • Fluorescein angiography
    • Micron III (Phoenix Research Labs) for rodents
  • Corneal / fundus scaning imaging
    • Spectral Domain Optical Coherence Tomography (SD-OCT)
  • Intraocular pressure (IOP)
    • Tonometry: TonoPen, TonoVet, LabVet
  • Complete eye tissue dissection / PK/ PD/ TK
    • Stereotaxic microscopy, fine ocular instrument
  • Intraocular lens (IOL) implantation / surgery
    • Phacoemulsifier: Alcon infiniti Vision System
  • Ocular implantation
    • Surgical microscopies
  • Immunohistochemistry (IHC) / Immunohistofluorescence (IHF)
    • Brn-3а for retinal ganglion cells
    • Isolectin B4 for neovascularization
    • Anti‑collagen type I for fibrosis
    • DAPI (4′,6-diamidino-2-phenylindole) for nucleic acid
  • Histopathology
    • Routine H&E (hematoxylin and eosin) staining
    • Special PAS (periodic acid schiff) staining for goblet cells

Support Services for Ocular Programs

  • Ocular Drug Research and Development
  • Surgical and Efficacy
  • Formulation Lab
  • IND/NDA Enabling Studies
  • Pathology
  • Ocular PK/Tissue Distribution

Ocular PK/Tissue Distribution

The purpose of this study is to evaluate the ocular distribution of the test article and a predicate control in the ocular tissues when administered topically to the surface of the eye.

Toxikon’s Expertise in Ocular Studies

Our multidisciplinary team provides expertise in the scientific and technical disciplines of ophthalmology, pharmacology, analytical and bioanalytical chemistry, and toxicology. Performed in a variety of models, Toxikon’s preclinical ocular studies include acute irritation, ocular tissue distribution, pharmacokinetic / pharmacodynamic (PK/PD), dose escalation, acute and repeat dose toxicity, required ISO and OECD/ ICH guideline testing programs, implantation, and drug screening and efficacy. Additionally, ocular protocols can be customized for targeted therapeutics, including ocular disease models.