Ophthalmology

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.

OCU400 gene therapy remained safe and tolerable across different mutation and dose cohorts in retinitis pigmentosa and Leber congenital amaurosis.

Based on the regulatory feedback provided by the FDA, Nanoscope announced plans to initiate Biologics License Application submission in Q1 2025.

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.

The resubmission includes positive data from a recently completed dry eye disease symptom trial requested by the FDA after a review of the previous NDA.

Phentolamine ophthalmic solution 0.75% effectively reversed pharmacologically-induced pupil dilation in the MIRA-2 and MIRA-3 clinical trials.

Individuals diagnosed with retinitis pigmentosa experienced an elevated risk of depressive disorder, compared with the general Korean population.

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.

Nanoscope Therapeutics announced the meeting with the FDA supported the advancement of MCO-010 into Phase 3 for Stargardt disease.

ATSN-101 was well tolerated 12 months after treatment and demonstrated on average, a 100-fold improvement in vision, with some improved by 10,000-fold.

Nearly 19% of dementia cases were attributable to ≥1 vision impairment in a nationally representative sample of older US adults.

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.

Panretinal photocoagulation followed by anti-VEGF injections increases the likelihood of PPV, compared with anti-VEGF therapy first.

After an initial switch to faricimab, anatomical measures showed improvement while no functional improvement was identified in real-world data.

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.