Wet AMD

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up to 24 weeks across currently-approved indications.

A Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 was set by the organization.

The first session of the 2025 COPHy meeting was titled "Big controversies in retina and beyond in 2025.”

The study is now expected to be fully enrolled with all 300 patients randomized by the end of 2024.

According to the company, the axitinib injectable suspension achieved all primary and secondary outcomes and maintained stable visual acuity and anatomical control over 9 months. There were no ocular or treatment-related serious adverse events.

Aleksandra Rachitskaya, MD, FASRS, speaks about the Vit-Buckle Society at the 2024 EURETINA Congress.

4D Molecular Therapeutics has announced data based on the longest interim follow-up from Phase 1/2 PRISM clinical trial and 4FRONT Phase 3 study design.

Gene therapy offers a promising alternative by potentially providing long-lasting effects from a single treatment.

This certification covers AI based regulatory requirements for the company's platform for AI imaging and diagnostic tools.

Adverum CEO Laurent Fischer spoke exclusively to Modern Retina about the 26-week interim analysis.

A novel formulation may prevent blood vessel growth and vascular leakage in the retina.

A team of researchers at the Ohio State University found that in mice an enzyme related to cell growth and division is a culprit in the blood vessel invasion in the back of the eye that causes blurred central vision in wet AMD.

The pharmaceutical candidate is being evaluated as a potential treat for nAMD.

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.

This study compared AVT06 with aflibercept (Eylea) in patients with neovascular AMD.

The company announced updated data from the OPTIC extension study of patients diagnosed with wet AMD during the Retina Subspecialty Day at the American Academy of Ophthalmology 2023 Annual Meeting in San Francisco.

This study will evaluate a potential gene therapy treatment in which a targeted gene directly to the retina.

Sophie Bakri, MD, MBA, shared insights from her presentation, "Comparison of the Antiangiogenic Profile of Tyrosine Kinase Inhibitors Vorolanib, Axitinib, and Sunitinib."

A panel of retina specialists review new and emerging treatments in neovascular AMD and DME, highlighting high-dose aflibercept and KSI-301. Which emerging treatments are you most interested in?

In recent panel discussions, leaders in the retina space shared their thoughts around AMD and DME. These key quotes showcase the heart of these discussions.

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).