• Ocutrx Technologies introduced the OcuLenz AR/XR headset 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 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. 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. Included in this new release are additional artificial intelligence (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. The enhanced features in this latest release allows for more streamlined processes and efficiencies in workflow.

• Genentech, a member of the Roche Group, announced a multi-year strategic research collaboration with NVIDIA that couples Genentech’s AI capabilities, 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 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, according to the annoucement. 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.

• Aldeyra Therapeutics announced receipt of a Complete Response Letter from the FDA for the new drug application (NDA) of reproxalap, an investigational drug candidate for the treatment of dry eye disease (DED). Although no safety or manufacturing issues with reproxalap were identified, the FDA stated in the letter that the NDA did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted. Per draft FDA DED guidance, efficacy in DED may be demonstrated with two symptom trials and two sign trials. Aldeyra conducted two trials for ocular redness as well as a DED symptom trial. On Nov. 16, 2023, Aldeyra submitted to the FDA a Special Protocol Assessment (SPA) for a DED chamber crossover clinical trial. The SPA review cycle is anticipated to be 45 days.

• Lupin Limited received approval from the FDA for its abbreviated NDA for bromfenac ophthalmic solution, 0.07%, to market a generic equivalent of Prolensa ophthalmic solution, 0.07% (Bausch + Lomb). Bromfenac ophthalmic solution, 0.07%, is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Lupin states it is the exclusive first-to-file for this product and is eligible for 180-day exclusivity. 



• Skye Bioscience treated the first patient in its Phase 2 clinical trial evaluating SBI-100 Ophthalmic Emulsion’s (OE) ability to lower IOP, safety and relevant biomarkers in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). SBI-100 OE is a synthetic prodrug of tetrahydrocannabinol that is able to bind and activate CB1 receptors in key ocular tissues. The trial is a double-masked, randomized, placebo-controlled study treating approximately 54 patients with elevated IOP (between 21 mm Hg and 36 mm Hg) diagnosed with POAG or OHT. The primary endpoints of the trial are to assess change in diurnal IOP vs placebo and ocular and systemic safety, and secondary endpoints are to assess ocular hypotensive efficacy at individual time points and application comfort. 

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.