Transscleral Pars Plana Choroid Ablation Using the Iridex Laser System Yields Improvements for Surgical Insertion of the Port Delivery Implant in a Minipig Model.

Purpose: To evaluate an alternative surgical approach for Port Delivery System with ranibizumab (PDS) implant and a novel application of Iridex laser system in Gottingen minipig model.

Methods: A total of seventeen male minipigs (Part 1: 9 animals in non-recovery and Part 2: 8 animals observed for 8-days post-surgery Part 2) received PDS implant insertion into each eye. The effect of Iridex 810 nm infrared diode laser with varying energy (power or duration) on transscleral pars plana ablation, surrounding ocular tissue and postsurgical vitreous hemorrhage (VH) was investigated.

International consortium for innovation and quality: An industry perspective on the nonclinical and early clinical development of intravitreal drugs.

The eye, which is under constant exposure to environmental pathogens, has evolved various anatomic and immunological barriers critical to the protection of tissues lacking regenerative capacity, and the maintenance of a clear optic pathway essential to vision. By bypassing the ocular barriers, intravitreal (IVT) injection has become the mainstay for the delivery of drugs to treat conditions that affect the back of the eye. Both small molecules and biotherapeutics have been successfully administered intravitreally, and several drugs have been approved for the treatment of (wet) age-related macular degeneration and diabetic macular edema.

Intraocular delivery considerations of ocular biologic products and key preclinical determinations.

Introduction: Ophthalmic diseases of the retina are a significant cause of vision loss globally. Despite much progress, there remains an unmet need for durable, long-acting treatment options. While biologic therapies show great promise, they present many challenges, including complexities in biochemical properties, mechanism of action, manufacturing considerations, preclinical evaluation, and delivery mechanism; these are confounded by the unique anatomy and physiology of the eye itself.

Direct Tie2 Agonists Stabilize Vasculature for the Treatment of Diabetic Macular Edema.

Purpose: Diabetic macular edema (DME) is the leading cause of vision loss and blindness among working-age adults. Although current intravitreal anti-vascular endothelial growth factor (VEGF) therapies improve vision for many patients with DME, approximately half do not achieve the visual acuity required to drive. We therefore sought additional approaches to resolve edema and improve vision for these patients.

Application of an organotypic ocular perfusion model to assess intravitreal drug distribution in human and animal eyes.

Intravitreal (ITV) drug delivery is a new cornerstone for retinal therapeutics. Yet, predicting the disposition of formulations in the human eye remains a major translational hurdle. A prominent, but poorly understood, issue in pre-clinical ITV toxicity studies is unintended particle movements to the anterior chamber (AC).