Comprehensive Services For Ophthalmic Drug Development

The eye is a highly complex organ with multiple barriers that make drug delivery particularly challenging. To maximize bioavailability while preserving vision and maintaining the structural integrity of the eye, formulation and delivery strategies must be meticulously designed. Every aspect, from selecting the optimal route of administration to ensuring stability and efficacy, requires specialized expertise.

Preclinical studies must be carefully planned, with the selection of appropriate animal models tailored to the specific therapeutic area and administration route of the investigational drug. As development progresses into clinical trials, the delicate nature of the eye and the paramount importance of patient safety become critical considerations. Additionally, the bioanalysis of trial samples presents unique challenges, as ophthalmic studies often involve rare and fragile biological matrices that demand highly specialized analytical techniques.

A deep understanding of the regulatory landscape is equally vital. Engaging proactively with regulatory agencies and adhering to evolving guidance can help streamline the approval process and mitigate potential obstacles. Successfully navigating these complexities requires a partner with extensive regulatory knowledge and scientific expertise in ophthalmic drug development.

By partnering with an integrated CRO/CDMO like Altasciences, sponsors can benefit from a seamless, end-to-end approach to drug development. From prototype formulation and preclinical testing to early-phase clinical trials and manufacturing, working with a single partner can accelerate timelines and improve efficiency—potentially reducing development time by up to 40%. With comprehensive support from day one through market approval, Altasciences ensures a strategic, efficient, and scientifically sound pathway for ophthalmic drug success.