Researchers at Pitt are developing a novel autologous serum ocular insert for treating dry eye disease. Traditional autologous serum eyedrops have several drawbacks, such as inconsistent preparation methods, short storage times, and frequent dosing needs. In contrast, the novel ocular insert offers longer shelf stability and less frequent dosing while providing the same benefits as traditional eyedrops. This insert is designed to reside in the lower eyelid and delivers a full day's worth of serum with minimal additional processing steps needed.
Description
Dry eye disease (DED) is a chronic condition affecting a large population, leading to negative effects on vision and quality of life. Current treatment approaches, such as over-the-counter lubricants and prescription options like cyclosporine A (CsA) and lifitegrast, have limitations in efficacy and applicability. Autologous serum eye drops (ASEDs) have shown promise in treating DED due to their similarities with native tears, but there are challenges with preparation, storage, and frequent dosing. The proposed innovation is an autologous serum ocular insert (ASOI) as a more convenient and reproducible alternative to ASEDs. The ASOI aims to achieve similar protein delivery as a full daily course of ASEDs while offering improved stability with simpler storage methods.
Applications
• Dry eye disease
Advantages
There are several unique features of the autologous serum ocular insert, including its ease of handling, enhanced stability during storage, and efficient delivery of serum proteins to the ocular surface. The insert also contains a backing layer of carboxymethylcellulose, which directs proteins toward the eye rather than the eyelid. The processing steps for the insert require minimal additives and the overall process is quick and simple. There are no other products in development with similar features, establishing the novelty of the innovation.
Invention Readiness
This technology is at the level of in vivo data. The first specific aim is to test the safety and efficacy of ASOI in vivo, comparing it with ASED treatment in a healthy rabbit model. The study will evaluate tear film concentration of key proteins, osmolarity, ASOI degradation, ocular surface health, and compatibility in a benzalkonium chloride-induced dry eye model. The second specific aim is to determine the stability and bioactivity of ASOIs in storage, evaluating pH, osmolality, protein concentration, mass, and bioactivity over time with different storage conditions. The scientific premise is based on the understanding of lyophilization and protein stability, and preliminary data demonstrate bioactivity maintenance after lyophilization and reconstitution.
IP Status
https://patents.google.com/patent/WO2025080727A1
