• Ikerian AG and RetinAI Inc. US launched RetinAI Discovery for Clinics, with two product versions to address the needs of ophthalmologists and optometrists. Discovery for Clinics and its AI models are designed to accelerate and enhance clinical decision workflows, teleophthalmology management, referral decisions, and patient management generating data efficiencies and enhancing decisions for clinics. The platform harmonizes, aggregates and connects large datasets on a single, cloud-based repository for data. The data is then automatically analyzed with RetinAI’s AI algorithms for accelerated and AI-biomarker based treatment decisions. The AI models can be processed on DICOM and other formats for OCT and fundus imaging. Both versions of Discovery for Clinics have progression analytics to help track trends in outcomes and provide visualization to patients on the progression of their disease. 

• SightGlass Vision announced the FDA granted Breakthrough Device Designation to its Diffusion Optics Technology spectacle lenses, which are intended to slow myopia progression in children. The company says the design is the first to use the contrast management mechanism of action, incorporating thousands of elements that gently scatter light across the retina. SightGlass Vision's patent-protected technology has demonstrated proven efficacy and safety through clinical evaluation, the company says. As reported in Sept. 2023, full 4-year outcomes from the company’s pivotal CYPRESS study showed statistically significant slowing of axial length progression and cycloplegic spherical equivalent refraction.

• The "Global Intraocular Lens Market, Size, Forecast 2024-2030, Industry Trends, Share, Growth, Insight, Impact of Inflation, Company Analysis" report (ResearchAndMarkets.com) shows the IOL market size is expected to grow from US$ 4.23 billion in 2023 to US$ 6.11 billion by 2030, growing at a CAGR of 5.39% during 2024-2030. The global IOL market is anticipated to grow drastically due to different factors, which includes the rising incidence of cataracts, which has led to a surge in demand for cataract surgeries. Product developments, government assistance and reimbursement regulations have additionally contributed to the market's growth. Initiatives to reduce the backlog of cataract surgeries and raise consciousness about eye care in essential worldwide locations are also anticipated to expand the market throughout the forecast period. For more highlights from the report, click here.

• Ocular Therapeutix announced the first three subjects have been screened and received their first aflibercept injection in the Phase 3 SOL-1 clinical trial of AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet AMD. AXPAXLI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties being evaluated for the treatment of wet AMD and other retinal diseases. The company previously announced FDA agreement on its special protocol assessment agreement modification on Jan. 25.


• Opthea Limited completed enrollment of all patients in its COAST Phase 3 pivotal clinical trial investigating sozinibercept (OPT-302, a vascular endothelial growth factor [VEGF]-C/D inhibitor) in combination with aflibercept, an anti-VEGF-A therapy, for the treatment of wet AMD. The sozinibercept clinical program includes two Phase 3 pivotal trials, COAST and ShORe. In the COAST trial, sozinibercept is being evaluated in combination with 2.0 mg of aflibercept. In the ShORe trial, sozinibercept is being evaluated in combination with 0.5 mg of ranibizumab. The primary endpoint for both trials is the mean change in BCVA from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy. Each trial will also evaluate the use of sozinibercept treatment dosed every 4 weeks and every 8 weeks after the first three loading doses. Enrollment in ShORe is expected to be completed in calendar Q2 2024.

• Eversight eye bank and Emmecell, a private clinical-stage biotechnology company, announced a partnership to advance cell therapies for the treatment of eye disease. Emmecell’s minimally invasive cell therapy injects healthy corneal endothelial cells obtained from donor corneas into the eye to repopulate the patient’s diseased cornea with functioning endothelial cells, potentially eliminating the need for transplantation. According to the announcement, corneal endothelial cells from a single donor tissue could be amplified using Emmecell’s technology to restore vision for hundreds of patients via injectable cell therapy. Using a proprietary Magnetic Cell Delivery nanoparticle platform, Emmecell aims to solve the therapeutic challenges of delivery, retention and integration of healthy donor cells. US patients may be eligible to enroll in Emmecell’s minimally invasive, multicenter, Phase 1B clinical trial for the treatment of corneal edema. To learn more, click here. 

• In a new study published in Nature Communications, researchers from Mass Eye and Ear, uncovered key genes, biological processes and cell types that may affect the pathogenesis of primary open-angle glaucoma (POAG) in IOP-dependent and independent manners. Researchers conducted a comprehensive study that combined genetic discoveries from a large cross-ancestry genome-wide association study meta-analysis of POAG, and a large meta-analysis of IOP with genetic regulation studies and single cell expression measurements in glaucoma-relevant eye tissues. Using integrative analyses, they identified hundreds of genes and regulatory effects underlying more than 100 loci associated with POAG and/or IOP that may contribute to glaucoma risk through altered gene expression levels. By utilizing single-nucleus gene expression data from the aqueous humor outflow pathways, retina and the optic nerve head and surrounding posterior tissues, as part of a cell atlas of the whole eye, the researchers identified known and less well-established cell types in which gene dysregulation may affect optic nerve degeneration. For more, see the study results here.

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.