Weekly Ophthalmic Newsletter

1. FDA Approves Biocon Biologics’ Yesafili?, Interchangeable Biosimilar Eylea

Biocon Biologics announced that the US FDA has approved the Company’s first-to-file application for Yesafili? (aflibercept-jbvf), an interchangeable biosimilar aflibercept.

YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization (myopic CNV). It is highly similar to the reference product Eylea? (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea?.

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2. KDB GLIDE? Receives FDA 510(k) Clearance for Expanded Indication in Glaucoma Treatment

New World Medical announced a significant milestone with the receipt of 510(k) indication expansion from the U.S. Food and Drug Administration (FDA) for KDB (Kahook Dual Blade) GLIDE.

This clearance allows for the reduction of intraocular pressure (IOP) in adult patients with primary open-angle glaucoma (POAG) during cataract surgery or as a standalone procedure, making KDB GLIDE? the only goniotomy device with this indication.

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3. Researchers Pioneer New OCT Technique for Scleral Structure Analysis

In a study published in the journal JAMA Ophthalmology, researchers at Tokyo Medical and Dental University in Japan have successfully pioneered a new optical coherence tomography (OCT) technique. This innovative method, known as polarization-sensitive OCT (PS-OCT), provides unprecedented insights into the detailed structure of the sclera—the white outer layer of the eyeball.

Using this technique, the team investigated the properties of the collagen fibers in the sclera of patients with highly myopic eyes. They also focused on the link between myopathy and a sometimes-pathological condition known as dome-shaped macula (DSM), in which a specialized area in the retina bulges outwards.

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4. Novel Resin Technology Could Improve 3D Printing of Intraocular Devices

Researchers at the University of East Anglia have developed a novel resin suitable for 3D printing intraocular devices. This pioneering innovation holds the potential to revolutionize the production of eye implants, which are crucial for cataract and refractive surgeries, by enhancing their customization and precision.

Dr. Aram Saeed, the lead author and Associate Professor in Healthcare Technologies at UEA's School of Pharmacy, emphasized the significance of this development: "For the first time, we have developed a resin that can be used to print ocular devices directly. While still in the early stages, the ability to 3D print these lenses could significantly enhance eye care for patients by offering unprecedented levels of customization and design precision, potentially leading to better clinical outcomes."

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5. Rezolute Announces Positive Phase 2 Results for Oral Drug in DME Patients

Rezolute, Inc. announced promising topline results from its Phase 2 clinical study of RZ402. This study targeted patients with diabetic macular edema (DME) who were either na?ve to or had limited exposure to anti-vascular endothelial growth factor (anti-VEGF) injections.

According to Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, and a member of Rezolute’s Scientific Advisory Board, the results are monumental for the DME community. "I am impressed by the significant reduction in CST in this study across all three dosages as retinal thickness is the key biomarker to determine whether a therapy may offer a potential benefit to patients. These data are very encouraging and are supportive of the potential for a new first-line, non-invasive treatment for DME."

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