Ophthalmic drug development is different.
At iuvo BioScience, our team of ophthalmic scientists know the eye, its compartmental structure and function, and the unique technical and regulatory challenges that ocular pharmaceutical development presents. To help you develop your ophthalmic product, we can partner with you in the following areas:
- Consulting: Our consulting services can help chart a course for the nonclinical assessment and testing of your ocular product to meet the regulatory requirements and the major milestones of your program. We can serve as your nonclinical team representative and help with preparation of regulatory documents.
- Product Development: We can advise on ocular product development, including formulation development, stability program design and conduct, preservative efficacy testing, and extractable/leachable characterization.
- Testing: Our technical staff can help design and conduct your ocular dosing study, whether it be an ocular pharmacokinetic study, screening and dose range finding studies, or GLP toxicology study. We can dose by a variety of routes including topical (drop, impregnated contact lens), subconjunctival, peri-ocular, sub-Tenon’s, intracameral, and intravitreal. We recognize that clinical observations are often the most critical outcomes for ocular toxicology studies. Therefore, our internal experts and external consultants, using a variety of assessment tools, such as slit lamp microscopy with photographic capabilities, binocular indirect ophthalmoscopy, retinal imaging, tonometry (applanation, rebound), esthesiometry, pachymetry, OCT, and ERG, are diligent in their observations and assessments, ensuring that your data is of the highest quality.
