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Virgilio Morales-Canton, Jans Fromow-Guerra, Samantha Salinas Longoria, Rafael Romero Vera, Michelle Widmann, Samirkumar Patel, Benjamin Yerxa; Suprachoroidal Microinjection of Bevacizumab is Well Tolerated in Human Patients. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3299.
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To evaluate the safety and tolerability of a single microneedle injection of bevacizumab into the suprachoroidal space (SCS) using a Clearside Biomedical proprietary microneedle
Four adult patients with choroidal neovascularization (CNV), secondary to wet age-related macular degeneration (AMD), were enrolled in a phase 1, single-center, open-label study. Each patient provided informed consent and was screened for eligibility. Following application of topical anesthesia, the patient was administered a single unilateral injection of 100 µL bevacizumab (Avastin®) into the SCS using an 850 µm 33 gauge Clearside Biomedical microneedle. The microneedle was inserted into the sclera approximately 8-12 mm posterior to the limbus in the superior temporal quadrant. Treated patients remained in the clinic for 4 hours for observation and then returned multiple times for follow-up during a 2 month period. Major safety examinations included intraocular pressure (IOP), angiograms, biomicroscopy, indirect ophthalmoscopy, fundus photography, optical coherence tomography (OCT), visual acuity (VA), and assessment of pain
Preliminary data shows that four patients were successfully dosed into the SCS which was confirmed via ophthalmoscope immediately following injection. A moderate level of pain was recorded for the administration. There were no unexpected or serious adverse events related to bevacizumab or method of administration on ophthalmic examinations. No negative effect on IOP was noted in any patient. No patients required rescue therapy or reinjection during the two months following treatment
Preliminary data suggests that the SCS can be successfully and safely dosed via the Clearside Biomedical proprietary microneedle using only topical anesthesia. These data show that 100 µL bevacizumab can be delivered into the SCS without unexpected or serious adverse events
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