Phase I DAVIO Trial: EYP-1901 Bioerodible, Sustained-Delivery Vorolanib Insert in Patients With Wet Age-Related Macular Degeneration.
| Autor: | Patel S; Retina Research Institute of Texas, West Texas Retina Consultants, Abilene, Texas., Storey PP; Austin Retina Associates, University of Texas Dell Medical School, Austin, Texas., Barakat MR; Retina Macula Institute of Arizona; University of Arizona College of Medicine - Phoenix, Phoenix, Arizona., Hershberger V; Florida Eye Associates, Melbourne, Florida., Bridges WZ Jr; Asheville Eye Associates, Asheville, North Carolina., Eichenbaum DA; Retina Vitreous Associates of Florida, Saint Petersburg, Florida., Lally DR; New England Retina Consultants, Springfield, Massachusetts., Boyer DS; Retina Vitreous Associates Medical Group, Los Angeles, California., Bakri SJ; Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota., Roy M; EyePoint Pharmaceuticals, Watertown, Massachusetts., Paggiarino DA; EyePoint Pharmaceuticals, Watertown, Massachusetts. |
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| Jazyk: | angličtina |
| Zdroj: | Ophthalmology science [Ophthalmol Sci] 2024 Apr 09; Vol. 4 (5), pp. 100527. Date of Electronic Publication: 2024 Apr 09 (Print Publication: 2024). |
| DOI: | 10.1016/j.xops.2024.100527 |
| Abstrakt: | Purpose: To evaluate safety and tolerability of EYP-1901, an intravitreal insert containing vorolanib, a pan-VEGF receptor inhibitor packaged in a bioerodible delivery technology (Durasert E™) for sustained delivery, in patients with wet age-related macular degeneration (wAMD) previously treated with anti-VEGF therapy. Design: Phase I, multicenter, prospective, open-label, dose-escalation trial. Participants: Patients with wAMD and evidence of prior anti-VEGF therapy response. Methods: Patients received a single intravitreal injection of EYP-1901. Main Outcome Measures: The primary objective was to evaluate safety and tolerability of EYP-1901. Secondary objectives assessed biologic activity of EYP-1901 including best-corrected visual acuity (BCVA) and central subfield thickness (CST). Exploratory analyses included reduction in anti-VEGF treatment burden and supplemental injection-free rates. Results: Seventeen patients enrolled in the 440 μg (3 patients), 1030 μg (1 patient), 2060 μg (8 patients), and 3090 μg (5 patients) dose cohorts. No dose-limiting toxicity, ocular serious adverse events (AEs), or systemic AEs related to EYP-1901 were observed. There was no evidence of ocular or systemic toxicity related to vorolanib or the delivery technology. Moderate ocular treatment-emergent AEs (TEAEs) included reduced visual acuity (2/17) and retinal exudates (3/17). One patient with reduced BCVA had 3 separate reductions of 17, 18, and 16 letters, and another had a single drop of 25 letters. One severe TEAE, neovascular AMD (i.e., worsening/progressive disease activity), was reported in 1 of 17 study eyes but deemed unrelated to treatment. Mean change from baseline in BCVA was -1.8 letters and -5.4 letters at 6 and 12 months. Mean change from baseline in CST was +1.7 μm and +2.4 μm at 6 and 12 months. Reduction in treatment burden was 74% and 71% at 6 and 12 months. Of 16 study eyes, 13, 8, and 5 were injection-free up to 3, 6, and 12 months. Conclusion: In the DAVIO trial (ClinicalTrials.gov identifier, NCT04747197), EYP-1901 had a favorable safety profile and was well tolerated in previously treated eyes with wAMD. Measures of biologic activity remained relatively stable following a single EYP-1901 injection. These preliminary data support ongoing phase II and planned phase III trials to assess efficacy and safety. Financial Disclosures: The author(s) have no proprietary or commercial interest in any materials discussed in this article. (© 2024 by the American Academy of Ophthalmology.) |
| Databáze: | MEDLINE |
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