Unique Setting and Expertise for Unmet Medical Needs

Untreated ocular diseases, such as age-related macular degeneration (AMD), can result in significant vision loss and blindness. Effective drug delivery to the posterior segment of the eye remains a significant challenge, and intraocular delivery represents an important approach for achieving localized therapeutic exposure. This represents a key segment of patient-centric dosage forms.

In addition to extended-release suspensions, lipid emulsions, and injectable gels, intraocular implants can provide sustained drug delivery over periods ranging from weeks or months to potentially years. These implantable systems leverage engineered polymers and device architectures to enable localized and controlled drug release at the site of treatment. By maintaining therapeutic drug concentrations while limiting systemic and off-target exposure, intraocular implants have the potential to improve treatment efficacy, reduce dosing frequency, and minimize treatment-related side effects.

Intraocular implant technologies may address several limitations associated with conventional ocular drug-delivery approaches, including inadequate or short-lived therapeutic drug concentrations in the target tissue. Implant design can be tailored to achieve specific drug-release profiles and accommodate a range of therapeutic modalities, including small-molecule drugs, peptides, proteins, and other biologic or therapeutic agents.

Long-acting intravitreal implants can enable sustained, localized delivery to the posterior segment of the eye, with the potential to reduce dosing frequency and maintain therapeutic exposure over extended periods; they epitomize patient-centric dosage forms.

A Versatile Platform for Posterior Segment Drug Delivery

Advances in biotechnology have enabled the development of novel therapeutic modalities for the treatment of ocular diseases. Effective delivery of these molecules to the posterior segment of the eye presents significant opportunities for the development of intraocular implants capable of providing targeted and sustained drug delivery.

Polymer & Formulation Science

Combination of biodegradability of polymers with the physical properties of drugs can enable tailor the delivery of drugs to meet patient needs.

• Polymer selection based on target release duration and product requirements
• Evaluation of polymer molecular weight, molecular-weight distribution, composition, and end-group chemistry
• Assessment of API-polymer compatibility
• Optimization of drug loading and content uniformity
• Manipulation of material properties to support processing and controlled drug release
• Utilization of internal polymer and materials expertise to accelerate formulation screening

This structure-process-performance approach enables implant properties to be systematically tailored to the target product profile.

Implant Engineering & Process Development

PSI has extensive experience and deep expertise in developing intraocular implants, leveraging polymer process engineering practices to optimize product development and enhance the manufacturability of the final products.

• Hot-melt extrusion (HME) of drug-polymer formulations
• Development of processing parameters appropriate for the API and polymer system
• Engineering of implant diameter and length based on dose and delivery-device requirements
• Implant cutting and dimensional control
• Optimization of implant geometry to influence drug loading and release characteristics
• Development of reproducible, scalable manufacturing processes
• Analytical characterization of critical material and product attributes
• Process scale-up from development through clinical manufacturing

An integrated development strategy evaluates interactions among these variables to establish a robust product and manufacturing process.

Drug – Device Integration

Considering administration devices for implant delivery during development can ensure successful clinical trials and commercialization. PSI’s device capability offers one-stop service for development of combination products.

• Selection of an appropriate implant applicator
• Compatibility of implant dimensions with needle and applicator requirements
• Integration with client-selected or client-provided delivery devices
• Drug-device assembly and combination-product development considerations

Analytical Excellence for Intraocular Development

The analytical expertise that PSI has streamlines development to meet client timelines.

• in vitro eluting for assessing the release rate and duration of implants
• real-time studies with extended duration (weeks to months to years)
• development of a meaningful accelerated in vitro release test for QC purposes
• Physical characterization of implants evaluates the mechanical properties
• Assessment by SEM and optical microscopy enables problem solving fundamentally due to material microstructure
• Development of procedures to extract drug from the matrix to allow for assay and impurities testing. This assesses potential degradation of the drug during the manufacturing process and terminal sterilization.
• Polymer molecular weight characterization to understand polymer changes on storage or terminal sterilization that may impact drug release rate
• Solid-state characterization to understand interactions between drug and polymer systems