Ophthalmology

4D-150 shows promising efficacy and safety in DME as FDA greenlights Phase 3 trial for Biologics License Application submission.

A recent study showed expression profiles of amacrine cells, the interneurons within the retina, were enriched in schizophrenia genetic risk factors.

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

Additional TEASE-3 participants who completed 24 months of gildeuretinol therapy reported no progression in Stargardt disease, including stable visual acuity.

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

OCS-05 meets primary safety endpoints and demonstrates a neuroprotective structural benefit, as well as visual improvement, in topline results from ACUITY.

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

From groundbreaking therapies to ethical dilemmas, HCPLive’s top podcasts of 2024 delivered expert insights and human stories across medicine.

We spotlight 5 impactful regulatory decisions scheduled to occur during the first quarter of 2025.

Glycemic control continues to be a major risk factor for diabetic retinopathy, while overweight, obesity, and hypertension are growing in prevalence.

The FDA-approved Scanly, a home-based OCT device, revolutionizes nAMD care by empowering patients with self-monitoring and enhancing personalized treatment.

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, Quan Dong Nguyen, MD, and Jia-Horung Hung, MD, discuss the Phase 2 Neptune trial investigating brepocitinib for active non-infectious uveitis.

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, Kay presented an overview of gildeuretinol, an oral vitamin A derivative offering hope for patients with Stargardt disease.

At AAO 2024, Khurana discussed rapid visual and structural gains for uveitic macular edema with vamikibart, paving the way for Phase 3 trials.

Decreasing Vitamin A dimerization could be a potential mechanism to treat geographic atrophy, according to results from the two-year SAGA study at AAO 2024.

Pegcetacoplan injection showed increased benefit for subfoveal GA, with as few as 6 injections, over 3 years in the GALE extension trial.

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

TRS01 eye drops demonstrate a positive benefit-risk profile for potential use as a first-line treatment in anterior non-infectious uveitis.

The 24-month data showed a notable response rate in study eyes treated with a high dose of AGTC-501, with a generally safe and tolerable clinical profile.

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