Ophthalmic Drug Discovery And Testing Services

An eBook cover titled "Simplifying The Path: Performance Testing for Ophthalmic Drug Discovery" by Pharmaron. The blue and white themed cover with icons highlights key areas like preclinical ADME studies, and there's a download button on the right side inviting users to "Download Below".

Accelerating Development with Integrated Preclinical Testing for Eye Therapies

Ophthalmic drug discovery can face significant challenges. Getting medicine into the eye isn’t easy. Its structure and natural defenses make it hard for treatments to reach the right spot and work well. That’s why you need a focused plan built for the eye—not just a standard drug approach.

Pharmaron tackles this with proven testing methods that help show your product works the same as the original. That’s key if you’re aiming for FDA approval, especially for generic eye drugs through the ANDA process.

It answers key industry concerns:

How can we establish bioequivalence without relying on systemic absorption?
What alternative models are accepted for ophthalmic product testing?
How do we demonstrate therapeutic equivalence in non-oral dosage forms?

Capabilities

Knowledge Center

Ocular Testing Services

Ocular Tissue Testing

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Why Ophthalmic Drug Delivery Needs Specialized Testing

Standard bioequivalence tests that work for pills don’t really work for eye drugs. The FDA and the Office of Generic Drugs now look for different kinds of data to prove that these local treatments are just as effective as the original.

Key barriers include:

Low systemic absorption of topical ocular drugs
Unique anatomy and local tissue targeting
Lack of validated biomarkers for some endpoints

Pharmaron solves this by using a three-part testing setup: lab tests, tissue tests and live studies. Each one is matched to how the drug is given and where it’s supposed to work.

Regulatory Insight: Building the Weight of Evidence

The FDA no longer accepts one-size-fits-all approaches for ophthalmic ANDA submissions. Pharmaron integrates multiple orthogonal datasets to meet this regulatory shift.

A strong equivalence case relies on:

Consistent results across in vitro, ex vivo and in vivo models
Tissue-specific pharmacodynamic response
Statistical alignment with FDA’s SUPAC-SS guidance (1997)

Pharmaron’s Expertise in Ophthalmic Drug Development

Pharmaron brings:

IND/NDA and ANDA-enabling services
Tissue-based assays across ocular, nasal and dermal routes
Expertise in metabolism, permeability and PK/biodistribution
GLP and non-GLP platforms tailored for regulatory alignment