Wet AMD

Outlook Therapeutics seeks FDA clarity on ONS-5010 after a complete response letter, aiming to address efficacy concerns for wet AMD treatment.

AMD treatment may become unrecogniable as gene therapies evolve.

FDA issues a complete response letter to Outlook Therapeutics for ONS-5010, citing insufficient evidence of effectiveness for wet AMD treatment.

Catch up on recent advancements in retina care, including new therapies for age-related macular degeneration and macular telangiectasia, enhancing patient outcomes.

Sandoz will oversee commercialization of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia under the terms of the agreement.

Patients weigh in on the value of provider communication.

The agreement is for a planned clinical trial of AXPAXLI (also known as OTX-TKI) for the treatment of non-proliferative diabetic retinopathy (NPDR).

REGENXBIO initiates a pivotal trial for surabgene lomparvovec, aiming to transform diabetic retinopathy treatment and improve patient outcomes.

Genentech reveals five-year data showing Susvimo effectively maintains vision in wet AMD patients with fewer injections, offering a promising treatment alternative.

EyePoint Pharmaceuticals completes enrollment for the LUCIA trial, advancing DURAVYU's potential as a new treatment for wet AMD.

Research from the iMIND lab at Duke University.

The trial will evaluate AXPAXLI in at least 555 patients in a multi-center, double-masked, randomized (2:2:1), 3-arm study.

The pivotal phase 3 clinical trial is the first of 2 that will evaluate the use of DURAVYU for the treatment of wet age-related macular degeneration.

The VAN-2401 phase 1 clinical trial will evaluate the use of KH658 for the treatment of wet AMD.

The company announced 27 abstracts at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting from May 4 to 8 in Salt Lake City.

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.