Ophthalmology

With a completed 12-week analysis, Outlook Therapeutics plans to resubmit the Biologics License Application for ONS-5010 in the first quarter of 2025.

With a Phase 3 trial expected in 2025, linsitinib is the first oral small-molecule therapy to demonstrate statistical significance in thyroid eye disease.

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

All participants with RP treated with OCU400 gene therapy achieved vision improvement or preservation at 2 years of the Phase 1/2 trial.

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.

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.

At AAO 2024, Borkar discusses the visual acuity benefit of ONL1204 ophthalmic solution for patients with macula-off rhegmatogenous retinal detachment.

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.

At AAO 2024, Do describes the durable vision gains and anatomic improvements achieved with aflibercept 8 mg for DME over 3 years of the PHOTON trial.

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.

At AAO 2024, Cunningham describes the clinical response and safety of faricimab (Vabysmo) in underrepresented populations with diabetic macular edema.

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