Clinical Observations - Square - Edited

May 10, 2024 - Clinical Observations

Updated every Friday

HanAll Biopharma has initiated a Phase III VELOS-4 study to evaluate the efficacy and safety of tanfanercept in dry eye based on the findings from the previous Phase III VELOS-3 study, in which tanfanercept demonstrated statistically significant improvement on the secondary dry eye outcome measures. The topline data from the Phase III VELOS-4 study is expected in the second half of 2025, HanAll says.

AsclepiX Therapeutics reports completing patient enrollment in the DISCOVER trial of AXT107 (gersizangitide) for the treatment of retinal vascular diseases. The trial is evaluating the safety and tolerability of three doses of AXT107 [125 µg (n=3), 250 µg (n=3), and 500 µg (n=9)] and determining the bioactivity and duration of action when injected suprachoroidally. Secondary endpoints will include efficacy as assessed by central subfield thickness and best-corrected visual acuity.

EyePoint Pharmaceuticals reports that the Phase II PAVIA trial evaluating Duravyu, the vorolanib intravitreal insert previously known as EYP-1901, did not meet its primary endpoint in patients with nonproliferative diabetic retinopathy (NPDR), although the data demonstrate that Duravyu had a biologic effect. EyePoint says it plans to provide an update on the path forward for Duravyu for NPDR following a review of the full 12-month data, which did show a favorable safety and tolerability profile with no treatment-related ocular or systemic serious adverse events reported.

Boehringer Ingelheim presented positive data from the HORNBILL Phase I/IIa study of BI 764524 for people living with diabetic macular ischemia (DMI). The study found that BI 764524 was well tolerated following intravitreal administration of single and multiple doses, meeting its primary safety endpoints and showing early signs of potential efficacy.

Inflammasome Therapeutics has dosed the first patient in the Phase I trial of the K8 intravitreal implant for geographic atrophy (GA) caused by age-related macular degeneration (AMD). Inflammasome is developing what it calls a new class of inflammasome inhibitor drugs, Kamuvudines.

From the Association for Research in Vision and Ophthalmology meeting (ARVO), Anexon presented Phase II data on ANX007 in patients with vision loss from GA. The new data are the first to show preservation of both vision and relevant anatomical structures following treatment with ANX007. Annexon says it will advance ANX007 into registrational Phase III trials in GA, the ARCHER II and the ARROW trial, a head-to-head trial with pegcetacoplan (Syfovre, Apellis Pharmaceuticals). Both are to be initiated later this year. The Phase II data showed significant protection against vision loss in the foveal and nonfoveal regions, as well as in low-light environments, along with a significant reduction in photoreceptor loss and meaningful deceleration of lesion growth.

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Rich Kirkner

Rich Kirkner

Contributing Editor
rich@healthegy.com

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