Wet AMD

A panel of retina specialists weighed in on the dosing intervals when using of faricimab for the treatment of neovascular AMD in the clinical practice setting. Do you agree with them?

The experimental gene therapy was administered as a treatment in part of a randomized, partially masked, controlled, phase 3 clinical study evaluating the efficacy and safety of an experimental therapy, ABBV-RGX-314, for wet AMD.

According to Outlook Therapeutics, it is working with the FDA to address the agency’s issues.

According to Regeneron, the approval was based on data in the PULSAR and PHOTON trials, in which the drug demonstrated clinically equivalent vision gains to aflibercept Injection 2 mg that were maintained with fewer injections.

Adverum Biotechnologies, Inc. provided an update on the company’s ongoing Phase 2 LUNA trial evaluating ixoberogene soroparvovec (Ixo-vec) for the treatment of wet age-related macular degeneration (wet AMD).

According to Regeneron, visual gains and safety of aflibercept 8 mg remained consistent with the established profile of aflibercept 2 mg injection.

RGX-314, an investigational formulation being developed in collaboration with AbbVie, may be a potential one-time treatment for nAMD, diabetic retinopathy, and other chronic retinal conditions.

According to Clearside Biomedical, a pair of presentations at the ASRS annual meeting in Seattle highlight CLS-AX as a potential treatment option for wet AMD treatment with a new mechanism of action and the possibility for longer duration of effect than current therapies.

Going forward, sozinibercept will be the official moniker of OPT-302, which holds fast track designation from the US Food and Drug Administration (FDA).

Clearside Biomedical developing a long-acting therapy for the treatment of retinal diseases, including wet AMD.

According to 4DMT, the Dose Expansion stage of the PRISM trial is a multicenter, randomized study designed to evaluate the safety and efficacy of 4D-150 at two different dose levels.

Retina experts discuss the benefits of using intraocular steroids to treat patients with DME as well as their approach to switching to steroids after a poor response to anti-VEGF therapy.

Expert retina specialists provide an overview of the YOSEMITE and RHINE clinical studies of faricimab in the treatment of DME.

Carl Regillo, MD, FACS, FASRS, and Prethy Rao, MD, MPH, discuss the phase 3 trials of faricimab in the treatment of DME and highlighting the enhanced resolution of intraocular fluid.

Nathan Steinle, MD; Adrienne Scott, MD; Carl Regillo, MD, FACS, FASRS; and Prethy Rao, MD, MPH, review the challenges presented in the management of DME, including the disease burden on the patient.

Retina experts discuss biomarkers to track disease progression in neovascular AMD, as well as their thoughts on the utility of optical coherence tomography angiography (OCT-A).

Drs Nathan Steinle, Adrienne Scott, Carl Regillo, and Prethy Rao share their approaches to dosing recommendations for faricimab in the treatment of neovascular AMD.

Expert retina specialists review the safety profile of faricimab compared with other anti-VEGF therapies in AMD.

Adrienne Scott, MD; Carl Regillo, MD, FACS, FASRS; and Prethy Rao, MD, MPH, discuss patient selection for faricimab in neovascular AMD, as well as approaches to switching to faricimab after a poor response to other treatment.

Data presented at the ASGCT 2023 Annual Meeting supports that Adverum’s Ixo-vec allows for lower dose administration with improved inflammation profile.

AIV007 is a broad spectrum tyrosine kinase inhibitor, targeting the convergence of fibrosis, angiogenesis, and inflammation.

Expert retina specialists discuss the use of faricimab and dosing for the treatment of neovascular age-related macular degeneration in the clinical practice setting.

Drs Nathan Steinle, Adrienne Scott, and Carl Regillo comment on the phase 3 trial outcomes of faricimab in neovascular AMD.

Retina experts discuss treatment of wet AMD, focusing on frequency of treatment and treatment breaks, and fluid tolerance.

Adrienne Scott, MD; Carl Regillo, MD, FACS, FASRS; and Prethy Rao, MD, MPH, provide an overview of the effect of anti-VEGF treatment in neovascular age-related macular degeneration and diabetic macular edema.

Researchers compile data from around 18,000 patients to provide a comprehensive understanding of the current state of nAMD treatment in the UK.

VLTR-557, Valitor's long-acting anti-VEGF biologic in development for durable wet age-related macular degeneration (AMD) treatment, showed that a single intravitreal (ITV) injection has potential to maintain clinical efficacy for more than six months.

Adverum Biotechnologies Inc. shared nonclinical data at ARVO 2023 in New Orleans that staggered, bilateral administration of Ixo-vec in NHPs was well tolerated with encouraging therapeutic activity and no signals of increased inflammation.

The results indicated that SB15 had similar efficacy, safety, immunogenicity, and pharmacokinetics compared to aflibercept out to week 56 of the phase III trial.

Clearside Biomedical plans to open enrollment for their Phase 2b clinical trial of CLS-AX this quarter. Topline results are expected by the Q3 of 2024.