Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders

Abstract

Purpose This study assessed physician-investigator experience with suprachoroidal (SC) injections, an investigational therapeutic administration technique using a 900 or 1100 µm microneedle to inject drugs into the SC space. Methods Datasets from six clinical trials across three diseases (noninfectious uveitis; diabetic macula edema, and retinal vein occlusion) were assessed. In addition to a user survey, retrospective correlations were performed between procedural variables (needle length), and demographics, and ocular characteristics. Results In the user survey, 84% (31/37) of physician-investigators did not perceive the SC injections to be meaningfully more challenging than other ocular injections. For the correlation analysis, the 900 µm needle was used for 71% (412/581) of baseline injections, and switching to the longer needle occured in the remaining 29% of baseline injections. No statistical correlations were found between needle lengths and age, race, disorder, refraction, visual acuity, intraocular pressure, retinal central subfield thickness, or lens status. Patient gender and needle length were statistically associated, with 76% (210/275) versus 66% (202/306) of injections administered with 900 µm needles for female and male gender, respectively. Injection quadrant correlated to needle length with 78% (214/275) of superotemporal quadrant injections administered with 900 µm needles, compared with 65% (73/113) of inferotemporal quadrant injections. Conclusions Both the user survey and the correlation analysis demonstrated that SC injection is well accepted by physician-investigators, and the two needle lengths accommodate a wide range of anatomic and demographic variables. Translational Relevance These results, along with the presented ex-vivo endoscopic imaging, suggest that SC injection could be readily adopted in clinical practice for targeted compartmentalized delivery of ocular therapeutics.

Biomechanics of suprachoroidal drug delivery: From benchtop to clinical investigation in ocular therapies

“…Further analysis revealed moderate correlations between the site of injection and the ultimate needle length used to deliver study drug, with the 900 µm needle being most commonly used in the superotemporal quadrant and the 1100 µm needle being most frequently used in the inferonasal quadrant [56]. This aligns with known scleral thickness variations, with the superotemporal quadrant generally showing the thinnest scleral of the quadrants [19,22].…”

“…A post hoc analysis was conducted across six clinical trials (PEACHTREE, AZALEA, TANZANITE, TOPAZ, SAPPHIRE, and TYBEE) focusing on baseline injections, the first suprachoroidal injection administered by the investigator to a patient. In this analysis, the 900 µm needle was used for 71% (412 of 581) of suprachoroidal injections; the 1100 µm needle was subsequently used to complete the remaining injections [55,56]. Additionally, in response to the prompt 'Was the suprachoroidal injection administered?…”

Suprachoroidal Triamcinolone Acetonide for the treatment of Macular Edema Associated with Retinal Vein Occlusion: A Pilot Study

“…Delivery to the SCS via microneedles exhibit convenient pharmacodynamics preclinically as it provides posterior and circumferential distribution of agents injected anteriorly (20,23) and it has been shown to be safe and effective clinically in Phase 3 trials of CLS-TA using microneedle-based technology, the SCS Microinjector® (Clearside Biomedical, Alpharetta, GA), which is supplied with two 30G microneedles with xed free lengths of 900 or 1100 μm (22,24,25).…”

“…Delivery of therapeutics into the SCS provides a novel alternative approach that has theoretical appeal, as it dominantly targets chorio-retinal tissues with posterior and circumferential distribution while relatively restraining delivery to the unaffected anterior segment and the vitreous chamber, thus reducing hazards associated with off-target effects which enhances its safety pro le (20). This hypothesis was further proven by many preclinical and clinical studies through microinjectors (21)(22)(23)(24)(25), which has been shown to provide a safe, minimally invasive, and reliable method of targeting SCS (25). In addition, extended duration of action and desirable pharmacokinetic properties have been reported for small molecule suspensions including Triamcinolone Acetonide (TA), with the potential to lessen the burden of treatment (21).…”

Evaluation of Long-Lasting Potential of Suprachoroidal Axitinib Suspension Via Ocular and Systemic Disposition in Rabbits

“… 29 A recent study assessed physician–investigator experience with microneedle-based SC injection across six clinical trials and three disease states. 30 A user survey was conducted, along with a retrospective correlation analysis between procedural variables, demographics, and ocular characteristics. This study demonstrated that microneedle-based SC injection is well accepted by physician–investigators, and that it can accommodate a wide range of anatomic and demographic variables.…”