How We Have Helped

OSOD has conducted over 1000 projects in our 30-year history spanning the development process from initial iterative investigative studies, to chronic GLP-compliant safety studies, to advising on clinical testing strategy.

The eye is often at the forefront of innovatative therapies and we have been involved with many.  Our skilled ophthalmologists and technicans have the ability to administer therapies and evaluate their safety in all laboratory animal species from rodents, to minipigs, to nonhuman primates.

As a primary preclinical partner for the development of approved ophthalmic therapies and clinical testing approval for many others, we know our approach works.  

Lucentis - 2006

O'Neill, C.A.,, 2003. 26-week intravitreal injection toxicity study with rhuFab VEGF in cynomolgus monkeys with an 8-week recovery. Investigative Ophthalmology & Visual Science, 44(13).

Eylea - 2011

Zimmer, E.,, 2006. Safety evaluation of intravitreal administration of VEGF trap in cynomolgus monkeys for 13 weeks. Investigative Ophthalmology & Visual Science, 47(13).

Xiidra - 2016

Murphy, C. J.,, 2011.  The pharmacologic assessment of a novel lymphocyte function-associated antigen-1 antagonist (SAR 1118) for the treatment of keratoconjunctivitis sicca in dogs. Investigative ophthalmology & visual science, 52(6).

Susvimo - 2020

Bantseev, V.,, 2020. Evaluation of surgical factors affecting vitreous hemorrhage following port delivery system with ranibizumab implant insertion in a minipig model. Retina (Philadelphia, Pa.), 40(8).

Durysta - 2021

Shen, J.,, 2020. Nonclinical pharmacokinetic and pharmacodynamic assessment of bimatoprost following a single intracameral injection of sustained-release implants. Translational Vision Science & Technology, 9(4).

Ocular Services In-Depth Case Studies:

Optimize Implant Formulation

Case Study:
The Challenge

Develop a sustained-release drug formulation for an intracameral implant to treat ocular hypertension

Correlate PK/PD/Tox data in the beagle

The Solution

Our Team

  • Veterinary Ophthalmologists
  • Glaucoma Specialists
  • OCT Imaging Specialists
  • CRO Technical Staff, IOP-Trained

Our Work

Animal Screening at Supplier

  • Anterior Segment OCT for anterior chamber size.
  • IOP for proper range
  • Behavior for conscious IOP Quality

Ocular Surgery

  • Implantation of a subcutaneous refillable infusion pump cannula to anterior chamber

Ocular PK/PD/Tox

  • Intracameral injection with novel injector device
  • Aqueous samples for drug analysis
  • Training for quality IOP data
  • OCT for appearance and safety
  • Clinical ocular exams for safety
The Outcome
  • OSOD technical expertise enabled the efficient and translatable optimization of the implant formulation
  • Successful Formulation Development

Consult on Unexpected Preclinical Finding

Case Study:
The Challenge

Development program status:
Phase 1 clinical trial complete and planning for Phase 2

Unexpected chronic safety finding:
"Corneal Opacity"


  • Is finding drug-releated?
  • What is relevance to patients?
  • What are the regulatory implications?
  • How best conduct Phase 2 surveillance?
The Solution

Our Team

  • Basic Scientists (cornea)
  • Regulatory Toxicologists
  • DVM and MD Ophthalmologists
  • MD Clinical Trialist

Our Work

  • Review the literature/study data and corneal images
  • Network with MD and DVM ophthalmologists from OSOD, the animal supplier and ACVO to clarify etiology and relevance of finding.
  • Partner with clinical planning and regulatory meeting

Our Advice

  • Include additional characterization of finding in ongoing preclinical safety study
  • Approach to Phase 2 clinical surveillance and protocol design
The Outcome

"Thanks for sending the summary in a timely manner. This is very helpful." ...and... "Once again a special thanks to the whole OSOD Team for the very productive discussion.

Phase 2 Ongoing