AMD

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.

The FDA recently approved Biologics' Yesafili as well as Samsung Bioepis and Biogen's Opuviz, both close copies of Regeneron Pharmaceutical’s Eylea. The approval offers ophthalmologists and patients additional therapeutic options.

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 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.

Expert retina speclialists discuss evolving treatment paradigms and the role of intravitreal steroids and macular laser for treating diabetic macular edema.

Katherine Talcott, MD, presents the case of a patient with diabetic macular edema, and the rest of the panel share their clinical experiences and discuss factors that inform the utilization of more durable agents.

Jaclyn Kovach, MD, FASRS, presents the case of a patient with neovascular AMD with persistent subretinal fluid, and members of the panel share their experiences treating similar patients.

Adiel Smith, MD, FASRS, presents the case of a patient with neovascular age-related macular degeneration (nAMD) with treatment-resistant pigment epithelium detachment, and the panel offers clinical insights on treatment decisions.

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

David Eichenbaum, MD, discusses his experiences with aflibercept, faricimab.

The molecule is being evaluated in 2 phase 3 clinical trials for wet AMD and is administered via intravitreal injection in combination with standard-of-care anti–VEGF-A therapy.

Hema Ramkumar, an ophthalmologist and founder of Oculogenex, sat down with David Hutton of Ophthalmology Times to discuss their connection with NASA and their experiment on macular degeneration-treated mice in space.

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

Experts discuss the use of steroids, particularly in the context of diabetic macular edema (DME). The inflammatory nature of DME reveals the effectiveness of steroids, especially in cases where persistent fluid remains despite anti-VEGF treatment.

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.