• Iveric Bio, An Astellas Company, announced the Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPS) J-code for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to AMD. The new J-code, J2782, is effective April 1, 2024. The permanent J-code for IZERVAY is expected to accelerate patient access in the United States and has been published on the CMS website here.

• Nicox SA announced the results from the Mont Blanc pivotal Phase 3 trial comparing NCX 470, a novel nitric oxide-donating bimatoprost eyedrop, to latanoprost in the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. Trial data showed the NO-donating prostaglandin analogue NCX 470 0.1% was well-tolerated and lowered IOP more than latanoprost in subjects with open-angle glaucoma or ocular hypertension at all six time points. With a dual mechanism of action that enhances both uveoscleral and trabecular outflow, NCX 470 could become a first-line therapy for IOP reduction in glaucoma, the company says. For more, see the study results here.

• Nanodropper Inc. announced the results from its clinical trial "An Evaluation of the Efficacy and Safety of Timolol Maleate 0.5% Microdrops Administered with the Nanodropper.” The trial enrolled glaucoma patients and demonstrated there was no clinically significant difference in the IOP-lowering effects of microdrops administered with the Nanodropper Adaptor compared to conventional eyedrops of timolol, an eyedrop medication commonly used to treat glaucoma. This was observed at all time points throughout the 8-hour study. Subjects in the microdrops arm also experienced a significantly smaller decrease in heart rate compared to those that received conventional drops, demonstrating there could be an enhanced safety profile of using a microdrop of timolol compared to a conventionally-sized eyedrop. For more, see the study results here.

• OKYO Pharma Limited announced additional key findings from analyses of the clinical data set from the 240 patient Phase 2, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease. Ocular pain relief showed statistically significant improvement as early as day 15, and the benefit was durable throughout the trial. Conjunctival Staining improved as early as day 29 with a durable benefit throughout the trial. Tear film breakup time showed statistically significant improvement as early as day 15 with the benefit durable for the remainder of the trial. Additionally, significant improvements were observed across multiple symptoms as measured in a daily symptom diary including pain, burning/stinging, eye dryness and itching within the first 2 weeks of treatment. For more, see the study results here.

• GenSight Biologics reported initial efficacy and safety results at 4 years post-treatment administration in the REFLECT Phase 3 clinical trial with LUMEVOQ (GS010; lenadogene nolparvovec). The results showed a sustained efficacy 4 years after injection, along with a continued benefit at 4 years in bilaterally treated patients: clinically meaningful improvement of at least 15 letters relative to their observed nadir. In addition, 73% of bilaterally treated patients experienced clinically meaningful level of improvement, and a favorable safety profile was confirmed at 4 years. The findings reinforce the results observed at 3 years post-treatment administration, which were reported in March 2023. For more, see the study results here.

• OnPoint Vision announced open enrollment of approved Investigational Device Exemption to begin Phase 1 of its pivotal clinical trial of the AccuraSee Intraocular Pseudophakic Capsular Lens (IOPCL) Magnifier (MAG) for secondary implantation in the capsular bag with a pre-existing 6 mm acrylic posterior chamber IOL. The IOPCL MAG is neutral optic (Plano power) with a central +10.0 D 1.8 mm zone designed to magnify near images when unilaterally implanted in low vision pseudophakic subjects with inactive AMD at least 6 months after cataract surgery. 

• LENZ Therapeutics announced the completion of its merger with Graphite Bio. The new combined company will operate under the name LENZ Therapeutics and will commence trading on Nasdaq under the ticker symbol “LENZ.” The company also announced that topline data from the Phase 3 CLARITY trials for lead assets LNZ100 and LNZ101 are expected in April 2024. The objective of the trial is to confirm the long-term safety profile of LNZ100 and LNZ101 over a 6-month period. Based on the data from the CLARITY trials, LENZ plans to submit an NDA to the FDA. LENZ intends to launch either LNZ100 or LNZ101 in the United States with its own commercial organization. 

• ABVC BioPharma announced that each of the company and its subsidiary BioFirst Corp. entered into a global licensing agreement with ForSeeCon Eye Corp. for the company's ophthalmology pipeline. The pipeline includes the medical device Vitargus, a biodegradable vitreous substitute to facilitate retinal reattachment surgery (valued at $187M, by third-party valuer). This license will cover the Licensed Products' clinical trial, registration, manufacturing, supply and distribution rights. ABVC will continue to serve as the R&D partner of ForSeeCon to discover new pipelines for ophthalmic products. 

• Of the 12 types of single-use surgical products examined in the “2023 Single-Use Ophthalmic Surgical Products Market Report” (Market Scope), ophthalmic viscoelastic solutions (OVDs) is the largest market segment and is estimated to have accounted for around 25% of single-use product revenue in 2023. Disposable instruments represent the second largest revenue category, with sales of around $530 million. Disposable knives and procedure packs are the third and fourth largest categories, both with revenues near $400 million. For more highlights from the report, click here. 

• An International Space Station (ISS) National Laboratory-sponsored investigation by Oculogenex will validate spaceflight as a novel biologic model of intermediate AMD. The company says it will allow them to evaluate its new gene therapy in the space environment, providing an opportunity to replicate a hard-to-study stage of the condition. The investigation seeks to ascertain whether gene therapy can thwart spaceflight-induced retinal dysfunction and degeneration. Female rodents on the space station will be used to conduct this experiment, considering that macular degeneration disproportionately affects women. Spaceflight will serve as a disease model for AMD, with oxidative stress induced by spaceflight mirroring pathways observed in patients on Earth. To learn more about this investigation, click 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.