• NeoLight announced FDA Class 2 clearance for ICON GO, its portable ophthalmic retinal imaging system with expanded fluorescein angiography (FA) capabilities. The system provides sharp retinal imaging quality across diverse patient care environments such as the pediatric intensive care unit, neonatal intensive care unit, operating room and emergency room. Designed to empower clinicians across the continuum of care for screening and treating newborns, ICON GO employs proprietary Direct Illumination technology, which ensures high-resolution and high-contrast retinal imaging and is particularly beneficial for darkly pigmented fundi. In addition, the system is optimized to minimize scatter at the edge of the field of view. The ICON GO with FA is available for purchase Q4 2023.

• Altris received FDA 510(k) clearance for its image and data management platform, Altris IMS. The platform is designed to import, store, manage, display, analyze and measure data from ophthalmic diagnostic instruments, including patient data, diagnostic data, clinical images and information, reports, and measurement of DICOM-compliant images. The cloud-based platform is also indicated for manual labeling and annotation of retinal optical coherence tomography scans. In addition, Altris IMS allows the user to manually annotate areas of interest in the images, calculate the layer thickness and volume from annotated images and present the progression of the measurements. Altris IMS also provides a tool for linear distance measuring of ocular anatomy and ocular lesion distances.

• Iveric Bio, an Astellas company, announced positive 24-month topline results from the Phase 3 GATHER2 clinical trial evaluating the efficacy and safety of IZERVAY (avacincaptad pegol intravitreal solution), a complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to AMD, that received FDA approval on Aug. 4, 2023. Topline results demonstrated that the IZERVAY monthly dosing regimen met the primary objective to significantly slow GA growth compared to sham at 24 months. Additionally, the treatment effect with the every-other-month dosing regimen for IZERVAY showed a similar reduction in the rate of GA growth vs sham. Overall, safety after 24 months of treatment was consistent with previously reported 12-month data, with no new safety signals identified. For more, see the study results here. 

• NovaBay Pharmaceuticals announced the commercial launch of Avenova Allograft in the United States through its physician-dispensed channel. This prescription product is the first optic allograft manufactured using BioStem Technologies’ proprietary process and is intended for use as a protective covering during the repair of ocular surfaces. It consists only of the amnion layer of the placental membrane and measures between 20-50 microns thick, making it ideal for delicate ophthalmic applications. Avenova Allograft is available in 8 mm, 10 mm and 12 mm diameter sizes. The product launch follows a previously announced agreement under which NovaBay was granted the right to commercialize BioStem Technologies’ Amniotic Tissue Allograft under the Avenova brand. NovaBay’s commercial launch of Avenova Allograft includes outreach programs aimed at educating eye-care specialists on both the clinical benefits of the product as well as the process for Medicare reimbursement. Order at www.avenova.com.

• Link Biologics Limited and Théa Open Innovation entered into an agreement to co-develop Link_TSG6 for the treatment of dry eye disease (DED) and other ophthalmology indications worldwide (excluding Asia). Link_TSG6 is a biological drug based on human TSG-6, a protein that has an intrinsic role to protect tissues from inflammatory damage. Link_TSG6 has been shown to have potent disease modifying properties in various preclinical models, including models of DED. Under the terms of the exclusive license and co-development agreement, in parallel with an equity investment from Théa Open Innovation, Link Biologics will be responsible for all DED research and development up to the end of Phase 2 trials, with Théa taking over responsibilities, including commercialization, thereafter.

• Otsuka Pharmaceutical and ShapeTX announced a multi-target collaboration to develop intravitreally delivered adeno-associated viruses (AAVs) for ocular diseases, with options to add additional targets and tissue types. The companies will collaborate to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology along with Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for people living with serious eye diseases. ShapeTX’s AI-driven AAVid platform combines massive throughput screening of billions of unique AAV variants and machine learning to identify novel AAV capsids for direct-to-NHP in vivo selection to maximize clinical translation. As part of the collaboration, ShapeTX will also apply the company’s transgene engineering technology to optimize payloads provided by Otsuka for therapeutic levels of gene expression in targeted cell types. 

• LSU Health New Orleans researchers discovered a key failure in AMD that may lead to progression and vision loss. The findings, published in Experimental Eye Research, suggests that AMD decreases an essential fatty acid, preventing the formation of a class of protective molecules and reducing repair potential. The study shows that AMD decreases peripheral retinal docosahexaenoic acid 22:6 in rod photoreceptor cells, limiting the elongation of fatty acids to form very-long-chain polyunsaturated fatty acids (VLC-PUFAs). VLC-PUFAs are precursors of elovanoids, bioactive chemical messengers made from omega-3 very long-chain polyunsaturated fatty acids. Elovanoids have been shown to restore the structure and integrity of damaged photoreceptor cells by repairing, remodeling and regenerating healthy cells. The loss of the neuroprotective precursors of elovanoids in the retina periphery from AMD facilitates uncompensated stress and cell loss. 

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.