Age-Related Macular Degeneration

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.

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.

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.

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

Our July 2024 month in review in ophthalmology includes the latest updates to the ophthalmological pipeline and a trio of studies on the treatment landscape for retinal diseases.

Geographic atrophy in eyes with dry AMD and macular atrophy in fellow eyes with neovascular AMD demonstrate similar growth rates.

A recap of the 5 most popular topics related to gene therapy in ophthalmology coming from the 42nd American Society of Retina Specialists meeting.

Hesitancy with anti-VEGF biosimilars was identified in a survey among both ophthalmologists and patients with nAMD in Canada.

Across 40 clinical scenarios, ChatGPT did not provide a comprehensive response in 50% of clinical questions with nearly 30% hallucinated sources.

Intravitreal dosing of sozinibercept up to 2 mg in combination with ranibizumab or aflibercept was well tolerated and supported ≥Q8W dosing intervals.

New data from RHONE-X at ASRS suggest over 90% of DME patients treated with faricimab (Vabysmo) were DME-free at 4 years, with nearly 80% on 3-4 month dosing intervals.

RGX-314 produced by the NAVXpress platform process showed a similar clinical profile to the adherent cell culture process in this Phase 2 pharmacodynamic study.

Phase 2 data from the ARCHER study shows a protective effect of ANX007 on visual acuity and anatomical measures in the central macula in patients with GA.

Veeral Sheth, MD describes an assessment of the need for supplemental injection use after EYP-1901 for wet AMD.

The PRISM trial's 24-week data show 4D-150 reduced anti-VEGF injection rates by 89% in wet AMD, with 77% of patients injection-free at 24 weeks.

We break down 5 top trials to keep an eye on at ASRS 2024, taking place in Stockholm, Sweden from July 17 to 20, 2024.

A case series analysis indicated that switching from aflibercept to faricimab could be a safe and effective option for patients with treatment-resistant nAMD.

Administrative claims database analysis revealed a lower AMD incidence in patients treated with JAK inhibitor therapy versus non–JAK-based immunotherapy.