Age-Related Macular Degeneration

Samsara Vision announced the implantable miniature telescope improved distance and near vision 6 months post-surgery for patients with late-stage AMD.

Aflibercept 8 mg achieves non-inferior vision gains with an every 8-week dosing interval in patients with macular edema following retina vein occlusion.

After accepting the avacincaptad pegol sNDA on January 6, 2025, the FDA has set a target action date for February 26.

A look back at some of our top coverage in ophthalmology from 2024, including pipeline news and FDA approvals.

ONS-5010 missed the pre-specified non-inferiority endpoint set with the FDA, but Outlook Therapeutics plans to resubmit the BLA in Q1 of 2025.

New 52-week LUNA and 4-year OPTIC data demonstrate Ixo-vec’s potential to reduce injection burden, maintain vision, and achieve lifelong benefits for wet AMD.

FDA grants Rare Pediatric Disease, Fast Track designations to gildeuretinol, aiming to accelerate treatment for Stargardt disease.

The sNDA was intended to include positive two-year data in the US Prescribing Information for avacincaptad pegol based on the GATHER2 clinical trial.

At AAO 2024, Wykoff discussed first-time extended results from AMARONE showing Restoret’s effectiveness in improving outcomes for patients with DME and nAMD.

At AAO 2024, Khanani discussed data showing a 97% reduction in annualized injection needs at 9 months with RGX-314 gene therapy.

Endophthalmitis incidence remained similar between face masking and non-face masking groups during anti-VEGF treatment.

In the Phase 2 ARCHER trial, ANX007 protected against visual acuity loss and remained well-tolerated for patients with geographic atrophy.

At AAO 2024, Schneider explains the pivotal trial outcomes of AI-based home OCT, compared with standard in-office OCT scans.

A history of anti-VEGF injections for retinal conditions may increase the incidence of complications after cataract surgery.

Topline results from the Phase 2b ODYSSEY trial show suprachoroidal CLS-AX achieved all primary and secondary outcomes for wet AMD.

This September 2024 month in review highlights recent advances in gene therapies and therapies demonstrating the potential for improved vision outcomes.

Gildeuretinol showed a clinically meaningful reduction in geographic atrophy lesion growth and a favorable safety profile at 24 months in the Phase 3 SAGA trial.

This August 2024 month in review highlights updates to the ophthalmic pipeline, metformin for geographic atrophy, and decreasing rates of postoperative endophthalmitis in the US.

A new treatment era was born with first-time geographic atrophy approvals in 2023, but many are still searching for the next addition to the treatment landscape.

Brolucizumab achieved non-inferiority in mean BCVA change to aflibercept in eyes with nAMD but demonstrated a higher incidence of IOI at 2 years.

A retrospective study in Japan identified 3 cases of non-infectious IOI associated with retinal vasculitis after aflibercept 8 mg treatment.

Nocturnal hypoxia may represent an additional modifiable risk factor for AMD, particularly its neovascular form.

Dr. Dennis Marcus discusses how the PDS with ranibizumab fits into the treatment landscape and explores other sustained delivery mechanisms currently in development for neovascular AMD.

A ranibizumab biosimilar lowers costs compared with aflibercept across all nAMD subtypes from both the patient and societal perspectives.

A retina surgeon reviews the key surgical steps for implanting the PDS, highlighting measures to prevent dislocation.