EyePoint Pharmaceuticals Presents Preliminary Safety Data from Phase 1 DAVIO Trial and YUTIQ® CALM Registry Study at American Society of Retina Specialists (ASRS) 39th Annual Meeting
– 3-month safety data from DAVIO trial continues to demonstrate EYP-1901 is well-tolerated in eyes with wet AMD –
– YUTIQ® CALM registry study collecting real-world data on patients with fluocinolone acetonide intravitreal (FAi) implant 0.18 mg is ongoing –
“We are excited to report that preliminary 3-month safety data for all patients from our ongoing DAVIO trial of EYP-1901 continues to demonstrate an excellent safety profile with no serious ocular or systemic adverse events reported to date,” said Nancy Lurker, CEO of EyePoint Pharmaceuticals. “These results support EYP-1901’s potential to provide wet AMD patients with a safe, effective and long-term therapeutic option. We are also pleased to present preliminary results from the CALM registry study, which allows us to better understand the patients we serve, and, subsequently, how we can ensure that YUTIQ, using EyePoint’s proprietary Durasert® technology, remains the most effective and innovative solution for our patients’ unmet needs.”
Summaries of the ASRS presentations are as follows:
Title: Initial Safety Results of the DAVIO Trial: An Open Label, Dose Escalation Phase 1 Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI) in Subjects with Wet AMD
Type: On-Demand Poster Presentation
The Phase 1 DAVIO open-label, dose escalation trial clinical trial of EYP-1901 enrolled 17 wet AMD patients across three dose cohorts. The study is ongoing, and all patients were previously treated with standard of care anti-VEGF therapies. Key safety observations through at least 3-months post-dosing for all patients include that no serious adverse events (SAEs), ocular or systemic, were reported. 21 ocular adverse events (AEs) were reported, all mild (19) to moderate (2) in severity, and there have been no reported AEs related to significant intraocular inflammation, best corrected visual acuity (BCVA) reduction, or elevation of intra-ocular pressure (IOP). No events of endophthalmitis, retinal detachment, or migration into the anterior chamber have been reported to date.
EyePoint plans to release interim efficacy results once the study has sufficient follow-up data for all dose cohorts later in the fourth quarter of this year.
Title: YUTIQ® CALM: A Real-World Registry Study of the Fluocinolone Acetonide Intravitreal Implant 0.18 Mg in Chronic Noninfectious Posterior Uveitis
Type: ePoster Presentation
The ongoing YUTIQ CALM real-world registry study is collecting data on patients who have received the fluocinolone acetonide intravitreal implant 0.18 mg. This study included patients of 18 years of age and older with a diagnosis of chronic noninfectious uveitis affecting the posterior segment and no contradictions to the FAi. Baseline and follow-up data are collected retrospectively and include central subfield thickness (measured via optical coherence tomography); best-corrected visual acuity; presence of inflammation; use of concomitant anti-inflammatory medications; and incidence of adverse events. Interim baseline data on patients in the registry as of
EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of EyePoint’s proprietary Durasert® sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided clear efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. Preclinical studies of EYP-1901 have shown anti-VEGF activity in disease models of ocular neovascularization and no serious safety issues were observed. EYP-1901 is initially being developed as a treatment for wet AMD, with the potential for additional indications in diabetic retinopathy and retinal vein occlusion.
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye, and was approved by the FDA on
About Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Non-infectious posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the
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Source: EyePoint Pharmaceuticals, Inc.