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).

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.

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.

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.

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.

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.

Explore cutting-edge ophthalmology innovations in this new series on the Ophthalmology Times EyePod podcast. Throughout this series, we'll hear insights from various stakeholders in clinical practice, academia, and industry. In this episode, host Ehsan Sadri, MD, engages in a conversation with Jeffry Weinhuff, managing partner at Visionary Ventures, exploring trends and offering advice for individuals driven by an entrepreneurial mindset.

The positive opinion concerns authorization of bevacizumab gamma (ONS-5010/LYTENAVA), a formulation of bevacizumab for treatment of wet age-related macular degeneration (wet AMD).

The prevalence of AMD features in Republic of Korea Air Force pilots was higher than in other general populations studied.

Experts discuss the approach to loading doses in the context nAMD and DME. Kaiser, MD explains that loading doses may not be necessary based on studies like the CAT study, while he highlights the importance of individualized treatment plans tailored to the specific needs of each patient and the nuances of different retinal diseases.

Judy Kim, MD and Peter Kaiser, MD discuss the significance of fluid dynamics in nAMD and DME, highlighting the detrimental effects of fluid fluctuations and emphasize the importance of minimizing these fluctuations to achieve better visual outcomes.

An investigation is set to launch on SpaceX’s 30th Commercial Resupply Services mission to the International Space Station contracted by NASA to test the therapy in space.

Judy Kim, MD and Peter Kaiser, MD reflect on the varying criteria for shortening or extending treatment intervals in clinical trials, emphasizing the need for standardization in large-scale studies. They highlight the importance of adapting trial criteria to clinical practice.