Ophthalmology Drug Development Expertise
The eye is one of the most complex organs in the human body, with multiple barriers to drug delivery. Its primary role is to transmit light to the retina in the back of the eye, translating visual signals to the brain so we can perceive the world around us.
Because of this unique structure and function, ophthalmology drug development is a highly specialized discipline requiring deep knowledge of formulation, physiology, and pharmacokinetics.
Ophthalmic drug development is often divided into two main areas: ‘front of the eye’ diseases and ‘back of the eye’ diseases. Both areas present distinct challenges for formulation, delivery, and pharmacology.
- Front of the Eye – Diseases such as glaucoma and dry eye disease.
- Back of the Eye – Retinal diseases including neovascular macular degeneration and macular edema.
Our Track Record in Ophthalmology
We currently support a number of companies developing biologics and small molecule concepts for both front and back of the eye drug development.
Our team has been directly involved in the development of multiple ophthalmic drugs, including:
We have also co-authored two Nature Communications papers on novel drug delivery approaches to the back of the eye (Graybug Vision and Ripple Therapeutics publications).
How We Support our Clients in Ophthalmology
We support clients with regulatory writing, including CTD IND submissions for ophthalmic disease indications. Our experience as ophthalmology drug developers also allows clients to outsource nonclinical and preclinical project management to Xyzagen. This means we can manage in vivo ophthalmology studies conducted externally or, when appropriate, execute studies in-house using rodent models for efficacy and pharmacokinetics.
With extensive expertise in ocular tissue sample analysis and pharmacokinetics, we support ocular drug disposition studies across species. Rodent studies are conducted internally at Xyzagen, while larger animal studies, such as rabbit ocular tissue distribution, are managed through select partner labs.
Xyzagen provides end-to-end support for ophthalmology programs, including:
Regulatory Writing
CTD and IND submissions for ophthalmic indications
Nonclinical/Preclinical Project Management
Outsourced management of in vivo ophthalmology models, or in-house execution in rodent models
Ocular Tissue Analysis
Expertise in drug disposition studies in rodents (internal) and non-rodents such as rabbits (through partner labs)
Clinical Pharmacology
GLP bioanalytical site management, clinical pharmacology study design and analysis and SME on clinical teams for clinical trial design.
Translational Expertise: From Nonclinical to Clinical
We work with both small molecule and large molecule ophthalmology programs, applying our core strengths in:
Our team partners with clinical operations and medical teams to ensure a cohesive clinical pharmacology strategy across all studies. This includes applying Model-Informed Drug Development (MIDD), population PK, and PK/PD modeling to strengthen decision-making.
Why PK Matters in Ophthalmology
Did You Know – Drug Development in the eye is shaped by unique biological factors:
These considerations underscore the importance of integrating PK insights early to reduce risk and optimize clinical outcomes.
Albumin in the back of the eye
Impacts small molecule protein binding
Biologics in the vitreous humor
Cleared primarily through fluid dynamics based diffusion, with pharmacokinetics largely dictated by molecular size unless it is designed to bind to vitreous components
Next Steps
Talk to us about how decisions made during nonclinical development directly impact clinical trial success. Explore our related services in laboratory testing, pharmacology models, and pharmacokinetics on our Solutions page—or reach out to our team to discuss your ophthalmology program.
