Despite advances in the treatment of ocular diseases, vision-threatening disease or eye injury remain the top 10disabilities among adults. Several of these ocular conditions require an anterior chamber paracentesis (ACP).ACP is clinically indicated to reduce acutely elevated intraocular pressure (IOP) to avoid risk of permanent visionloss and to sample aqueous humor for disease diagnostics and monitoring. Conditions requiring IOP reductioninclude acute angle closure glaucoma, pneumatic retinopexy to treat retinal detachments, and iatrogenic IOPelevations associated with intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents totreat diseases such as neovascular age-related macular degeneration, diabetic retinopathy and retinal veinocclusions. Conditions requiring aqueous humor sampling include endophthalmitis, uveitis, retinoblastoma andlymphoma, and aqueous biomarkers increasingly are guiding treatment selection and drug monitoring, e.g., withanti-VEGF agents. Unfortunately, there exists no instrument specifically designed for ACP, and insteadtuberculin syringes with standard excessively long needles and limited operational control are used. This requiresa steady surgeon hand and steady patient eye while the patient is positioned in the slit lamp biomicroscope, andoften requires an assistant. As a result, the ACP procedure may lead to serious complications, such as hyphemaand cataract due to inadvertent trauma to intraocular structures (e.g., cornea, ciliary body, iris and lens), and theaspiration rate and aqueous volume are difficult to control and unpredictable. Unfortunately, there have been noimprovements in the safety or efficiency of ACP in the past century. To overcome the limitations associated withexisting antiquated techniques, F Square Medical is developing and commercializing Parasafeâ¢, the first-everinstrument designed specifically for ACP procedures. The Parasafe instrument is a sterile, disposable andimportantly, safe instrument for controlled, rapid, and reproducible ACP without requiring a slit lamp or anassistant. Through the completion of a successful Phase I project, F Square Medical built a functional alphaprototype and assessed its performance and usability to inform beta prototype refinement. This Phase II programwill build upon the substantial Phase I data package and will focus on incorporating feedback from the Phase Iend-user data to refine and lock the Parasafe design for manufacture, as well as execute on the complete arrayof required design control activities per 21 CFR 820.30 to advance Parasafe to FDA regulatory 510(k)submission, approval, and scalable production. The completion of the proposed Phase II project will result in thefiling of a 510(k) regulatory submission to the FDA for Parasafe, an instrument with the potential to significantlyreduce the risk and expand the utility of ACP, thereby advancing this transformational instrument towardcommercialization and improving patient care.
Public Health Relevance Statement: PROJECT NARRATIVE
Ocular anterior chamber paracentesis (ACP) has the potential to transform the standard of care in
ophthalmology. For decades ACP has saved countless patients from irreversible blindness by alleviating acutely
elevated intraocular pressure, and now pioneering labs are recognizing aqueous humor as a reservoir rich in
diagnostic and predictive biomarkers. Unfortunately, there is no instrument specifically designed for ACP;
instead, off-the-shelf tuberculin syringes with excessively long needles and cumbersome handling are
repurposed with serious risks of intraocular trauma, poorly controlled aspiration rates, unpredictable fluid
volumes, and often require an assistant. To address this major and urgent unmet medical need, F Square
Medical is developing and commercializing the first-ever instrument designed and optimized for ACP:
Parasafeâ¢.
Project Terms:
