Age-related macular degeneration (AMD) and diabetic retinopathy (DR) are the leading causes of blindness in elderly patients worldwide. Over the past decade, anti-vascular endothelial growth factor (anti-VEGF) agents injected directly into the posterior segment of the eye have become the standard of care for AMD and DR. However, the injections are invasive, uncomfortable and difficult for patients to comply to. While anti-VEGF treatment is shown to be efficacious, the regimes studied especially for AMD have shown good outcomes only with monthly injections. Treatment regimens with varying injection protocols may have reduced efficacy and the prognostic outcomes remain uncertain. Moreover, the ocular and systemic safety of these repeated injections over long periods of time are unclear. Currently, clinical trial treatment regimens (monthly injections for 1-2 years) are difficult to replicate in real clinical settings.
The Simultaneous ExtractoR-Injector Device (SERID) is designed to simultaneously extract vitreous samples for biopsy and biomarker analysis, and inject therapeutic drug into the eye. We are also developing a biomarker test platform to provide early pre-functional indicators potentially for tailored treatments based on the patient’s current condition.
Technology Features, Specifications and Advantages
We have established a functional design for the SERID, which provides the integrated ability firstly for suction for vitreous humor extraction, and subsequent therapeutic injection. The device is able to deliver therapeutics safely by removing a sample first to prevent an acute spike in intraocular pressure (IOP) and reduce drug reflux from the eye. Therapeutics are then administered through the smaller bore needle which is within the larger bore needle at this point. The capability to analyze vitreous biomarkers through vitreous extraction enables clinicians to treat eye conditions before functional damage occurs. It also opens up opportunities to move away from protocol driven treatment regimens and instead tailor bespoke treatments for individuals based on their biomarker profiles. It also paves a new direction for biomarker discovery and research.
The goal of this integrated device is to reduce the number of injections to the eye, and provide a safe and reliable way to acquire vitreous samples and inject therapeutic drug into the eye simultaneously without causing a spike in IOP. A sudden increase in IOP may lead to other adverse reactions such as the increased risk of damage to intraocular structures and retinal detachment.
This is will be the world’s first intravitreal diagnostic-therapeutic system specifically designed for the eye. Potential licensees of this technology include ocular syringe suppliers and ocular drug manufacturers. This device will be used in the clinical setting, by qualified medical practioners. There are no direct competitors in the market that provide simultaneous biopsy and therapeutic injection capabilities.
As the number of injections given to patients increase and the demand on our clinical workforce intensifies, safety becomes an issue. Nurses are even replacing doctors to perform the injections in large tertiary centers. The SERID is expected to ease the clinical burden as a specifically designed device for the eye with safety and ergonomic features. The other advantages include reduction of frequent unnecessary injections, low risk of damage to intra-ocular structures, retinal detachment and vitreal hemorrhage. The device also has the potential to deliver a wide range of drugs with the use of standard syringe fittings. Monitoring VEGF or anti-VEGF agent levels from extracted fluids as a biomarker to determine specific dosage and injection frequency enables individualized and patient-tailored therapy. Current cost of ant-VEGF injections range from about S$700 to S$1800 depending on medication used. We envisage the SERID to be a one-time use device that will cost in the range of S$50-S$75 to the patient which could be included into an item bundle of care with the therapeutics. This premiere will serve to allow for better resolution of the disease and may in the long run save some patients the cost of additional injections that may not be necessary.