Screen Failures in Clinical Trials in Retina.

Purpose: Disparities in clinical trials are a major problem because of significant underrepresentation of certain gender, racial, and ethnic groups. Several factors including stringent eligibility criteria and recruitment strategies hinder our understanding of retinal disease. Thus, we aimed to study the various reasons of screen failures and specific patient and study characteristics among screen failures.

Efficacy and Safety of Faricimab for Macular Edema due to Retinal Vein Occlusion: 24-Week Results from the BALATON and COMINO Trials.

Purpose: To evaluate the 24-week efficacy and safety of the dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A inhibitor faricimab versus aflibercept in patients with vein occlusion.

Design: Phase 3, global, randomized, double-masked, active comparator-controlled trials: BALATON/COMINO (ClincalTrials.gov identifiers: NCT04740905/NCT04740931; sites: 149/192).

Safety and efficacy of ixoberogene soroparvovec in neovascular age-related macular degeneration in the United States (OPTIC): a prospective, two-year, multicentre phase 1 study.

Background: Gene therapy, successfully used in rare, monogenetic disorders, may prove to be a durable management approach for common, polygenetic conditions, including neovascular age-related macular degeneration (nAMD). Repeated injections, oftentimes monthly, and possibly for decades, of vascular endothelial growth factor antagonists (anti-VEGF), is the standard for nAMD. We hypothesised that an in-office, intravitreal administration of ixoberogene soroparvovec (ixo-vec, formerly ADVM-022), a single-dose gene therapy encoding for the proven anti-VEGF protein, aflibercept, would transform retinal cells to continually produce aflibercept to minimise treatment burden in nAMD.

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale.

Purpose: Dual inhibition of angiopoietin-2 and VEGF-A with faricimab (Vabysmo) offers excellent visual acuity gains with strong durability in patients with diabetic macular edema (ME) and neovascular age-related macular degeneration. The phase III BALATON/COMINO (NCT04740905/NCT04740931) trials will investigate the efficacy, safety, and durability of faricimab in patients with ME due to retinal vein occlusion (RVO).

Design: Two identically designed global, randomized, double-masked, active comparator-controlled studies.

Orbital Gas after 25-Gauge Pars Plana Vitrectomy with Incorrect Gas Mixture.

We present 2 cases of sutureless 25-gauge pars plana vitrectomy and fluid-gas exchange, in which incorrect gas concentrations likely led to elevated intraocular pressures and retrobulbar gas. Combined removal of orbital gas with anterior orbitotomy and pars plana vitrectomy was performed in the first case to address expanding intraocular and retrobulbar gas resulting from a suspected error in gas dilution. Vitreous and orbital gas removal by needling was effective in the second case.

The real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study - 6 month results.

Background/objective: Investigate real-world patients receiving faricimab for the treatment of neovascular age-related macular degeneration (nAMD).

Subjects/methods: Multicenter, retrospective chart review was conducted on patients treated with faricimab for nAMD from February 2022 to September 2022. Collected data includes background demographics, treatment history, best-corrected visual acuity (BCVA), anatomic changes, and adverse events as safety markers.

Review of gene therapies for age-related macular degeneration.

Gene therapies aim to deliver a therapeutic payload to specified tissues with underlying protein deficiency. Since the 1990s, gene therapies have been explored as potential treatments for chronic conditions requiring lifetime care and medical management. Ocular gene therapies target a range of ocular disorders, but retinal diseases are of particular importance due to the prevalence of retinal disease and the current treatment burden of such diseases on affected patients, as well as the challenge of properly delivering these therapies to the target tissue.

Angiopoietins as Potential Targets in Management of Retinal Disease.

The Ang/Tie2 pathway complements VEGF-mediated activity in retinal vascular diseases such as DME, AMD, and RVO by decreasing vascular integrity, increasing neovascularization, and increasing inflammatory signaling. Faricimab is a bispecific antibody that has been developed as an inhibitor of both VEGF and Ang2 that has shown positive results in phase I, II and III trials. Recent Year 1 data from phase III clinical trials YOSEMITE, RHINE, TENAYA, and LUCERNE have confirmed the efficacy, safety, durability, and superiority of faricimab in patients with DME and nAMD.

Port delivery system: a novel drug delivery platform to treat retinal diseases.

Introduction: Retinal disease treatment delivery is mostly limited to intravitreal injections and slow-release injectable implants due to structural barriers in the eye, and carry associated adverse effects and relatively high treatment burden. The Port Delivery System with ranibizumab (PDS) is a novel drug delivery device that is surgically implanted into the vitreous cavity and allows for continuous release of the anti-vascular endothelial growth factor (anti-VEGF) ranibizumab, eliminating the need for frequent intravitreal injections while maintaining therapeutic intraocular drug levels to control disease activity. Investigations of PDS are summarized in this review.

Reverse magnetic resonance signal from intraocular hemorrhage.

Purpose: To report the effect of massive intraocular hemorrhage on magnetic resonance imaging signal.

Methods: Case report.

Results: A 34-year-old power weightlifter developed sudden, nontraumatic loss of vision to no light perception in his right eye.

Fluorescein angiography of iris juvenile xanthogranuloma.

A 3-year-old boy was referred because of the presence of a non-pigmented, highly vascular mass with tapioca appearance involving the superior portion of the left iris. Iris fluorescein angiography revealed early hyperfluorescence of the iris tumor with diffuse, intense late leakage of dye throughout the entire iris, not just in the region of the tumor. Cytopathologic examination revealed Touton giant cells and the presence of histiocytes, confirming the diagnosis of iris juvenile xanthogranuloma.

Ultrasound biomicroscopy of eyelid eccrine hidrocystoma.

Case Report: A 58-year-old white female noted a lesion on her left lower eyelid, present for 3 months. Examination disclosed a dark-blue, subepithelial, smooth mass along the cilia near the punctum. The lesion did not transmit light and was thought to be a solid mass, such as a deep-blue nevus or melanoma versus a cystic mass with internal debris.

Intraocular lacrimal gland choristoma diagnosed by fine-needle aspiration biopsy.

Purpose: To describe an intraocular lacrimal gland choristoma confirmed with fine-needle aspiration biopsy in a child.

Methods: Case report.

Results: A 6-year-old Asian girl developed a pink, vascularized, cerebriform mass with marked corectopia in the inferonasal iris of the left eye.

Fine-needle aspiration biopsy of iris tumors in 100 consecutive cases: technique and complications.

Objective: To evaluate the technique and complications of fine-needle aspiration biopsy (FNAB) for iris tumors.

Design: Retrospective, nonrandomized, single-center case series.

Participants: One hundred eyes of 100 patients with diagnostically challenging iris tumors evaluated with FNAB.