• Genentech, a member of the Roche Group, announced a multi-year strategic research collaboration with NVIDIA that couples Genentech’s artificial intelligence (AI) capabilities, extensive biological and molecular datasets, and research expertise with NVIDIA’s computing capabilities and AI to speed up drug discovery and development. The collaboration is designed to enhance Genentech’s advanced AI research programs by transforming its generative AI models and algorithms into a next-generation AI platform to expedite the discovery and delivery of novel therapies and medicines to people. The companies will join forces to accelerate and optimize Genentech’s proprietary machine learning (ML) algorithms and models on NVIDIA DGX Cloud. NVIDIA will share its computing expertise with Genentech’s teams of computational scientists with the goal of optimizing and scaling Genentech’s models. The collaboration with NVIDIA complements Genentech’s AI/ML teams, which are developing and leveraging AI and ML foundational models across numerous research areas including diverse therapeutic modalities. The collaboration will also help accelerate Genentech’s “lab in a loop,” where experimental data feeds computational models that uncover patterns and make new, experimentally testable predictions.

• Ocutrx Technologies introduced the OcuLenz AR/XR headset that is designed to increase visual clarity for individuals living with AMD. The lightweight headset enhances vision by overlaying high-contrast, pixel-manipulated images onto the user's remaining viable field of view. The system processes real-world video imagery and then recreates it as an augmented reality display tailored to the user's remaining good vision. By shifting pixels from the impaired central vision area to the more effective peripheral vision, the headset compensates for the central vision loss characteristic of AMD. Its optical engine delivers 2.5K resolution per eye and has a wide field of view — 60° horizontally, 40° vertically and 72° diagonally. Designed for functionality and mobility, the headset allows users to move freely and perform everyday tasks while wearing it. Its power comes from a Qualcomm Snapdragon XR2 processor, and with wi-fi and cellular connectivity, the headset doubles as a connectivity tool akin to a computer, tablet or smartphone. OcuLenz is set for commercial release in the first half of 2024.

• Compulink Healthcare Solutions announced advancements to its Advantage SMART Practice EHR and practice management solution that the company showcased during AAO 2023. Included in this new release are additional AI-enabled features such as the ability for treatment plans to be auto-generated based on diagnosis codes and historic provider ordering patterns. The release also includes updates to its AI engine, Advantage AI Practice. Compulink also showcased its suite of clinical, financial and operational solutions that are designed to increase efficiency in ophthalmology practices.

• Keeler announced a partnership with Long Grove Pharmaceuticals. Long Grove Pharmaceuticals acquired the rights to AK-FLUOR (fluorescein injection) in both 10% and 25% formulations from Akorn Pharmaceuticals in May 2023. AK-FLUOR is indicated in diagnostic fluorescein angiography. To ensure the consistent availability of AK-FLUOR prior to its relaunch as a Long Grove Pharmaceuticals product, Long Grove reached a distribution agreement with the FDA Office of Drug Shortages through the Regulatory Discretion Process and has made available the existing AK-FLUOR inventory manufactured by Akorn Pharmaceuticals.

• REGENXBIO Inc. reported additional positive data from the ongoing Phase 2 ALTITUDE trial of ABBV-RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery. The data was presented at AAO 2023 by Mark Barakat, MD, Retinal Consultants of Arizona. ABBV-RGX-314 is being investigated as a potential one-time gene therapy for the treatment of wet AMD, DR and other chronic retinal conditions. The data showed that ABBV-RGX-314 continues to be well tolerated in 50 patients from dose levels 1 and 2 (Cohorts 1-3) with no drug-related serious adverse events. Dose level 2 prevented disease progression and reduced vision-threatening events in non-proliferative DR patients at 1 Year — 70.8% of patients achieved Diabetic Retinopathy Severity Scale improvement vs 25.0 % in control; 0% of patients worsened ≥2 steps vs 37.5 % in control; and ABBV-RGX-314 reduced vision-threatening events by 89% compared to control. For more, see the study results here.

• Oxurion NV announced topline data in its KALAHARI Phase 2, Part B clinical trial for DME (KALAHARI trial), did not demonstrate that its novel PKal Inhibitor, THR-149, improved vision as much as the comparator, the anti-VEGF therapy aflibercept, at Month 3 (the primary endpoint). The mean change in BCVA from baseline at Month 3 was -0.2 letters for the THR-149 arm and +3.5 letters for the aflibercept arm. The results confirmed that THR-149 was safe and well tolerated. The KALAHARI trial is the only ongoing trial sponsored by Oxurion. In light of these results and the company’s low cash position, the company stated it has decided to take the necessary steps to file for bankruptcy.

• LENZ Therapeutics and Graphite Bio entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company is expected to trade on Nasdaq under the ticker symbol “LENZ.” The lead programs of the combined company will address presbyopia. In connection with the merger, Graphite Bio has entered into a subscription agreement for a private investment in public equity financing that is expected to close concurrently with the completion of the merger of $53.5 million, with a syndicate of health-care investors led by LENZ’s existing investors and including participation from new investors. The merger is subject to stockholder approval of both companies, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission to register the securities to be issued in connection with the merger, and the satisfaction of customary closing conditions. It is expected that the net proceeds from the merger and concurrent financing will allow the combined company to continue to build infrastructure and successfully commercialize LENZ’s lead product candidate, subject to successful completion of the ongoing Phase 3 trials, and subsequent regulatory approval.

• The FDA issued a warning letter on Nov. 13 to Amazon for selling unapproved ophthalmic drugs on its website. The drugs listed in the letter include: Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eyes Floaters Relief and Manzanilla Sophia Chamomile Herbal Eye Drops products. The letter states that “Amazon is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a). Introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).” The FDA purchased these drugs through www.amazon.com. In the letter, the FDA deemed these products as “especially concerning from a public health perspective.”

• Using atomic force microscopy, researchers at Doheny Eye Institute, an affiliate of UCLA, discovered retinal capillary stiffening in diabetic mice that is causally linked to the development of retinopathy. Published in Diabetes, the study found that atomic force microscopy demonstrated that retinal capillaries in diabetic mice become stiffer in the early stages. Crucially, blocking this stiffening inhibited capillary degeneration and mitigated the loss of contrast sensitivity. Having identified the protein (lysyl oxidase) responsible for the increase in retinal capillary stiffness, the researchers administered an oral drug to diabetic mice that inactivated lysyl oxidase, successfully blocking capillary stiffening. Further investigation into the mechanism revealed that stiffer capillaries become more adhesive and sensitive to toxic immune cells that contribute to DR development, resulting in increased capillary cell death. The Doheny Eye Institute says these findings showcase the potential of an oral drug to inhibit retinopathy, thus eliminating the need for repeated eye injections, and introduce retinal capillary stiffness as a new target for DR prevention strategies.

• A multidisciplinary team led by researchers at the Schepens Eye Research Institute of Mass Eye and Ear identified a new strategy for glaucoma cell replacement therapy. In their new study, published in PNAS, the researchers changed the microenvironment in the eye in a way that enabled them to take stem cells from blood and turn them into retinal ganglion cells that were capable of migrating to and surviving in the eye’s retina. They conducted their study on the adult mouse retina, but the work’s implications could one day be applied to human retina. The researchers created retinal ganglion cells (RGCs) out of stem cells, then tested the ability of various signaling molecules known as chemokines to guide these new neurons to their correct positions within the retina. The research team utilized a “big data” approach and examined hundreds of such molecules and receptors to find 12 unique to RGCs. They found stromal derived factor 1 was the best performing molecule for both migration and transplantation. 

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.