News

DRSS stable/improved with OKT-TKI; drug well tolerated

Home-stored anti-VEGF drugs face risks from temperature changes, pointing to a need to protect efficacy and avoid dangerous contamination.

The transferrin vectorised therapy is being investigated for use in patients with dry age-related macular degeneration and geographic atrophy

The trial evaluated ONS-5010 in wet age-related macular degeneration patients, and the company plans to resubmit a Biologics License Application in the first quarter of 2025.

They report a case of endophthalmitis and undertook a literature review to identify previous infections with this pathogen.

Cost among other factors may deter patients from screening, especially in rural and low-resource settings.

In the 5 patients with bilateral geographic atrophy (GA) who received a K8 implant in 1 eye, there was a mean reduction in GA lesion growth of 66% at 3 months.

The funding will support activities like formal pharmacology and toxicology testing.

The company's lead product candidate Duravyu (vorolanib intravitreal insert), f/k/a EYP-1901, is anticipating topline data from several clinical trials in 2026.

The new funding will allow the company to complete its ongoing Phase 2 trial of proprietary nanomedicine, migaldendranib, in patients with wet AMD and DME

The retrospective SING IMT study included 35 patients (55 years or older) with late-stage age-related macular degeneration (AMD).

Previously, Teva was established as the European commercialisation partner of FYB201, Formycon's biosimilar to ranibizumab (Lucentis).

The objective of this trial was to evaluate safety and tolerability and identify dose level for further evaluation.

Whitecap is currently developing 2 therapies for potential use in glaucoma and geographic atrophy.

OCU400 demonstrated meaningful improvement of 2-line gain (10 letters on ETDRS chart) in low-luminance visual acuity (LLVA) in treated eyes when compared to untreated fellow eyes.

City Therapeutics will develop a novel RNAi clinical candidate toward a specific disease target for intravitreal administration.

This phase 2b study (ASPIRE) is currently underway.

The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration (FDA) and Astellas.

Several pharmaceutical companies have announced new appointments of executives and board members as they prepare for growth in 2025.

The financing will go toward its ongoing phase 2b/3 and planned pivotal phase 3 clinical trial for AVD-104.

ViGeneron also received approval for dose escalation in the ongoing phase 1b clinical trial.

In October, Oxular began a phase 2 trial for its therapeutic candidate OXU-001, for treatment of diabetic macular edema

Catch up on the clinical trial news, updates from the United States Food and Drug Administration (FDA), and company funding that you may have missed.

The primary safety endpoint was carried out through the percentage of patients with shift from normal (at baseline) to abnormal in any electrocardiogram (ECG).

The collaboration between KIST and Huons BioPharma will span 14 months.