AMD

The company expects approval from the EMA by 2025.

The biosimilar was approved for treating patients with age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

We asked what leaders in the retina field would tell residents and medical students as they train for the next decades in retinal care. Here's what 2 of them had to say.

According to the companies, the partnership will accelerate the development of lead product candidate, RO-104; a first-in-class tri-specific biologic for treating neovascular age-related macular degeneration.

A key distinction between patients seen in the clinic vs those enrolled in clinical trials has to do with characteristics dictated by the trial’s inclusion/exclusion criteria.

Researchers from the Case Western Reserve University School of Medicine and the Cole Eye Institute have found that supplement melatonin could be linked to a decreased risk of age-related macular degeneration.

Injection-free subgroup results demonstrated that a single intravitreal dose of 4D-150 without any supplemental anti-VEGF injections resulted in stable mean visual acuity that was equal to or higher than the standard bimonthly aflibercept control group at all 6 time points through Week 24.

The primary endpoint for the ReNEW and ReGAIN trials is the rate of change in the macular area of photoreceptor loss assessed by spectral domain-optical coherence tomography (SD-OTC) and ellipsoid zone mapping at week 48.

The IND approval will allow the company to initiate a Phase I/IIa clinical trial for its gene therapy treatment targeting wet Age-related Macular Degeneration (AMD) including Polypoidal Choroidal Vasculopathy (PCV).

According to the company, its Phase 3 program enrolled 1,984 patients across COAST and ShORe trials. Topline data from both pivotal trials are expected in 2025.

Investigators undertook a secondary analysis of the effects of long-term, low-dose aspirin in over 3,000 older adults who satisfied the inclusion criteria in the Aspirin in Reducing Events in the Elderly–AMD (ASPREE-AMD) study.

The agency approved Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis, Biogen) as biosimilars to Eylea (Regeneron Pharmaceuticals).

The submission for bevacizumab gamma (ONS-5010/LYTENAVA) follows a positive opinion from the CHMP in March.

Dr. Marion Munk examines the Phase 2/3 clinical trial of high-dose aflibercept (8 mg) in diabetic macular oedema, presenting key outcomes and clinical implications of the data.

Dr. Marion Munk reviews the Phase 3 clinical trial of high-dose aflibercept (8 mg) in neovascular AMD, emphasizing how this new therapy could alleviate the treatment burden for patients while providing superior outcomes.

The program will use OCT images to identify and monitor AMD in its early stages.

The SAB additions include Usha Chakravarthy, MBBS, PhD; Allen Ho, MD, FACS, FASRS, and Frank Holz, MD, FEBO, FAVO.

Experts conclude the series with the hope that longer-acting agents will lead to better real-world outcomes for patients, mirroring clinical trial results and potentially preventing vision loss, especially in countries with limited access to healthcare.

Experts discusses concerns related to the use of new agents, focusing on intraocular inflammation (IOI) and potential batch variations in biologics faricimab and aflibercept. He emphasizes close monitoring for IOI and advises clinicians to scrutinize patients for any signs of inflammation during follow-up visits.

Peter Kaiser, MD shares his early experiences with faricimab and high dose aflibercept for nAMD and DME. He notes positive outcomes, especially with hard-to-treat patients, and emphasizes the ongoing evaluation of patient response to treatment.

Age-related macular degeneration continues to be a key development area for many pharmaceutical companies as the work to develop new treatment options and present data in the first few months of the year.

Research around the globe is working not only to develop treatments for AMD, but also to determine risk factors for the disease to help prevent future cases.

Peter Kaiser, MD discusses the utilization of newer agents, faricimab and high dose aflibercept, for refractory patients who haven't responded well to previous treatments and for patients doing well but aiming to extend dosing intervals.