Wet AMD

The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar for wet AMD, DME, DR, RVO, and mCNV.

The FDA's OND found substantial evidence of effectiveness for bevacizumab-vikg in nAMD, clearing the way for a BLA resubmission in June 2026 and a decision expected within 60 days.

Victor M. Villegas, MD, discusses supraorbital vibration as an adjunct to topical anesthesia in a high-volume retina practice.

SOL-1 data show AXPAXLI extends wet AMD control, delaying fluid rebound and reducing rescue injections while sustaining vision through 52 weeks.

MALBEC (NCT07440225) is a randomized, double-masked trial evaluating the safety and efficacy of MK-8748 at 2 dose levels versus control (aflibercept 2mg).

In the JADE trial, OLN324 demonstrated numerically greater visual acuity gains and evidence of sustained retinal drying with fewer retreatments during a treatment-free follow-up period, compared with faricimab.

The JADE clinical study enrolled more than 160 patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD).

The pandemic reshapes treatment intervals for neovascular AMD, revealing flexible strategies that maintain visual outcomes and enhance patient care.

The FDA noted in the letter that it is unable to approve the application for ONS-5010/LYTENAVA (bevacizumab-vikg) in its current form for the treatment of wet AMD.

Ocular Therapeutix accelerates NDA plans for AXPAXLI, targeting wet AMD treatment, following promising phase 3 trial results.

Gene therapy revolutionizes retinal disease treatment, offering long-lasting solutions and reducing the need for frequent injections in patients with nAMD.

nAMD treatment options may offer positive outcomes to patients by reducing fluid fluctuations associated with poorer outcomes.

Sharon Fekrat discusses the complexities of antithrombotic use in wet AMD, highlighting the need for individualized treatment and future guideline development.

The company noted that this approval marks Celltrion's first Health Canada-approved biologic product in ophthalmology.

EyePoint Pharmaceuticals' DURAVYU trials for wet AMD receive positive DSMC review, highlighting safety and potential for improved patient outcomes.

CoTx-10 is intended for the treatment of retinal vascular diseases, such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

Anat Loewenstein, MD, discusses the transformative impact of home OCT and AI on monitoring retinal diseases at AAO 2025.

Research on aflibercept 8 mg reveals promising real-world outcomes for treating wet AMD and diabetic macular edema, enhancing vision and safety.

This resubmission follows the complete response letter (CRL) Outlook received in August 2025.

Ophthalmologists weigh in on how the extended-duration therapy may reduce treatment burden for patients with wet age-related macular degeneration.

The trial is evaluating 4D-150 in patients with wet age-related macular degeneration (wet AMD).

Under the terms of the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases in Japan, China, Australia, and other Asia-Pacific markets.

The trial will be evaluating AXPAXLI dosed every 6 months vs aflibercept (2 mg) dosed every 8 weeks in treatment-naive patients with wet AMD.

This acquisition will include Adverum’s lead candidate, Ixo-vec, a gene therapy treatment for wet AMD.