Ophthalmic End-To-End Drug Development Solutions

The eye is a multi-faceted organism with many barriers to drug delivery. Formulation and delivery options must be expertly planned and developed to ensure that the maximum bioavailability is achieved without negatively impacting vision or the physical structure of the eye. Planning of preclinical studies must consider the appropriate animal species for the route of administration and therapeutic area of the investigational drug. During clinical trials, the delicate nature of the eye and the importance of subject safety are key factors to take into account. As important, the bioanalysis of trial samples necessitates the use of techniques created especially for the often uncommon and frequently fragile matrices involved. Finally, understanding the regulatory environment and related guidances, as well as proactive and appropriate discussions with relevant agencies, when warranted, are critical components of the pathway that can help ensure a seamless experience.

The specific challenges and complexities in ophthalmic drug development can be mitigated by partnering with an integrated CRO/CDMO provider with extensive regulatory knowledge and scientific expertise in the ocular space.