AMD

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.

The company highlighted successful enrollment in the SOL-1 Phase 3 trial for wet AMD, plans for a new repeat dosing study (SOL-R), and positive 48-week data from the Phase 1 HELIOS study for NPDR

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.

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.

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.

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.

The reverse stock split is “part of the Company’s plan to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market."

In this insightful discussion on changing therapeutic approaches in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), Judy Kim, MD and Peter Kaiser, MD address barriers like step therapy and the impact of insurance-guided choices on treatment outcomes. The conversation emphasizes the need for a personalized approach, citing clinical trial data while acknowledging the challenges of aligning real-world practices with stringent trial protocols.

Investigators believe that AMD and cancer may have similar risk factors in common.

Rajendra Apte, MD, PhD, has received the Research to Prevent Blindness /American Macular Degeneration Foundation Catalyst Award for innovative research approaches in studying age-related macular degeneration.

The 3 participants have also received their first aflibercept injection for the treatment of wet AMD.

Twelve-week data from the Ph1b/2a AMARONE trial reveals Restoret to be well-tolerated in patients with diabetic macular edema and neovascular age-related macular degeneration.

Preliminary safety data support a favorable benefit-risk profile at both dose levels. The preliminary efficacy and safety data trending similar to or better than the OPTIC study, in which patients continue to see ongoing clinical benefit through at least 3 years.

The study further defined the relationship between delayed rod-mediated dark adaptation and the status of outer retinal bands on optical coherence tomography.

A minimum of 5,000 patients with up to 5 years of follow-up will be included in the study, with patients from a variety of practice settings and clinician experiences in 28 countries and 500 sites

Carl D. Regillo, MD, FACS, FASRS, discussed recent data from the DAVIO 2 trial in his presentation at the virtual Angiogenesis, Exudation, and Degeneration 2024.