Benzinga | Oct 12, 2021 03:01PM EDT

EyePoint Pharma Highlights Presentation Of Prelim. Data From Phase 1 DAVIO Trial, YUTIQ CALM Registry Study At American Society Of Retina Specialists Meeting

-- 3-month safety data from DAVIO trial continues to demonstrate EYP-1901 is well-tolerated in eyes with wet AMD --

-- YUTIQ(r) CALM registry study collecting real-world data on patients with fluocinolone acetonide intravitreal (FAi) implant 0.18 mg is ongoing --

WATERTOWN, Mass., Oct. 12, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced positive interim safety data from its Phase 1 clinical trial of EYP-1901, a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration (wet AMD), and preliminary results from YUTIQ(r) CALM, a real-world registry study of the fluocinolone acetonide intravitreal (FAi) implant 0.18 mg in chronic noninfectious posterior uveitis. The two studies were presented in a Paper-On-Demand and an ePoster Presentation, respectively, at the American Society of Retina Specialists (ASRS) 39th Annual Meeting held October 8 -- 12, 2021.

"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(r) 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

Presenters Vrinda S. Hershberger, MD, PhD; David R. Lally, MD; Mark R. Barakat, MD and Dario A. Paggiarino, MD

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(r) CALM: A Real-World Registry Study of the Fluocinolone Acetonide Intravitreal Implant 0.18 Mg in Chronic Noninfectious Posterior Uveitis

Presenters Ankur Shah, M.D. and Rene Choi, M.D.

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 August 2021 reveal that patients feature a substantial duration of uveitis (mean 57 months, or about 4.75 years), a variety of etiologies (largely unknown) and previous treatments (most often topical, intraocular and systemic corticosteroids and immunomodulatory drugs) in their medical history. Ocular characteristics include the presence of macular edema (mean CST 353.56 microns), relatively poor BCVA (mean 55.15 ETDRS letters) and an IOP generally in normal range (mean 13.35 mmHg). Most patients had relatively controlled intraocular inflammation as measured by AC cell and vitreous haze.