• On March 8, Congress passed a partial government funding bill that includes policies to address cuts to the Medicare Physician Fee Schedule that went into effect on Jan. 1. The legislation softens the decrease from -3.37% to -1.69% and took effect on March 9 running to the end of 2024. However, it does not provide for retroactive claims processing. In response to this bill, AAO CEO Stephen D. McLeod, said in a statement: “I’m glad to see Congress took action. However, it is distressing that the full cut was not eliminated, and this partial fix is still far from what is needed to bring long-term certainty and stability to a dysfunctional Medicare physician payment system. Congress must act on broader reforms to ensure that physicians can be there for all the patients who need them.” To learn about the solutions that the AAO supports, click here.

• NovaBay Pharmaceuticals and Eyenovia Inc. announced the signing of a co-promotion agreement to commercialize prescription ophthalmic products to physicians across the United States. Under the agreement, NovaBay will market Eyenovia’s clobetasol propionate ophthalmic suspension 0.05%, a steroid indicated for the treatment of inflammation and pain following ocular surgery, through its US physician-dispensed channel. Eyenovia will market NovaBay’s prescription Avenova Antimicrobial Lid & Lash Solution through its Mydcombi and Clobetasol sales representatives located across the United States. Clobetasol propionate ophthalmic suspension 0.05% is expected to receive a tradename this summer.

• The "Global Intraocular Lens Market by Type (Monofocal, Premium, Phakic), Material (Hydrophobic, Hydrophilic, Silicone) Application (Cataract, Presbyopia, Corneal Disorder), End User, Unmet Need, Buying Criteria, Reimbursement - Forecast to 2029" report (ResearchAndMarkets.com) shows the global IOL market is projected to reach USD 6.0 billion by 2029 from USD 4.2 billion in 2023, at a CAGR of 6.3% during the forecast period. Rise in the technological advancement in IOLs, the increasing global aging population and growing awareness of minimally invasive surgeries are some of the key growth drivers for the global IOL market. For more highlights from the report, click here.

• Virtual Vision Health added new features to its Virtual Eye Pro virtual reality visual field headset. The enhanced headset offers improved test modalities, reporting accuracy and repeatability comparable to standard automated perimetry tests, the company says. Portable testing can be conducted anywhere within or outside the practice with onboard audio instructions that replace the need for technician monitoring. The Live Eye Monitoring and Streaming feature uses 8 Tobii infrared cameras and lights to track gaze and improve exam reliability. The system alerts the patient if their gaze is not fixated on the focus point, freeing staff to perform other tasks in clinic while testing is conducted. Additionally, it enables pupillometry and improved ptosis and dermatochalasis testing. Physicans will have an opportunity to demo the Virtual Eye Pro at the 2024 ASCRS annual meeting. 

• MediPrint Ophthalmics completed its Glaucoma SIGHT-2, Phase 2b study evaluating the company’s lead candidate (LL-BMT1), a novel, preservative-free, weekly drug-eluting contact lens, vs a control group on bimatoprost 0.01% ophthalmic solution. The SIGHT-2 study evaluated safety and efficacy of LL-BMT-1 in 28 patients diagnosed with open-angle glaucoma for 3 weeks. Both groups achieved sustained reduction of about 30% from the baseline IOP. No serious treatment emergent adverse events were reported, and the lenses were well tolerated. An evaluation of dry eye and end of the day comfort for the contact lens carried out per CLDEQ-8 questionnaire also showed significant improvements.

• OcuTerra Therapeutics announced topline results from its Phase 2 DR:EAM clinical trial of nesvategrast (OTT166), a novel, selective RGD integrin inhibitor developed as an eyedrop. Topline data showed nesvategrast was safe and well tolerated, but the data failed to demonstrate a statistically significant improvement on the diabetic retinopathy severity scale (DRSS) for patients treated with nesvategrast compared to the placebo group, the primary efficacy endpoint. Data also did not show nesvategrast to have significant impact on the progression of disease as measured by DRSS, a key secondary endpoint. The analysis of the development of vision threatening events (VTEs), another key secondary endpoint, stratified by level of disease severity at baseline, demonstrated a statistically significant improvement in patients with DRSS level 47 and 53 (moderately severe, and severe non-proliferative DR respectively) at baseline in preventing the onset of VTEs by week 24 (p=0.045).

• Surface Ophthalmics is advancing its Kera Sol Tears, an over-the-counter artificial tear solution designed for cell-compatible, short-term, fast-acting, temporary relief of burning and irritation caused by dryness of the eye. The company also announced it is progressing the clinical program for its investigational drug, Mycosol (Surf-101), a first-in-class prescription eyedrop that delivers mycophenolate in the company’s proprietary formulation, which is designed to provide sustained immunosuppressive action and mucin upregulation at the ocular surface. Founder and chairman, Richard Lindstrom, MD, will lead Surface Ophthalmics into its next stage as it advances its patented proprietary portfolio for dry eye syndrome, the company says.

• Atsena Therapeutics announced dosing has been initiated in the second cohort of the LIGHTHOUSE study, a Phase 1/2 clinical trial evaluating subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). ATSN-201 was well tolerated in all three XLRS patients in the first cohort, and no serious adverse events were reported. The Data and Safety Monitoring Board recommended proceeding with the second cohort, in which patients will receive the next dose level of ATSN-201. ATSN-201, a gene therapy product candidate, leverages AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment. For more information about the study, click here. 

• Ocugen Inc. announced that dosing is complete in the first cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA) — a modifier gene therapy candidate being developed for geographic atrophy (GA). Enrollment in the first cohort is complete, and three subjects received 200µL single subretinal administration of the low dose (2.5x10¹⁰ vg/mL) of OCU410. The ArMaDa clinical trial will assess the safety of unilateral subretinal administration of OCU410 in subjects with GA. It will be conducted in two phases. Phase 1 is a multicenter, open-label, dose-ranging study consisting of three dose levels (low dose [2.5×10¹⁰ vg/mL], medium dose [5×10¹⁰ vg/mL] and high dose [1.5 ×10¹¹ vg/mL]). Phase 2 is a randomized, outcome accessor-blinded, dose-expansion study in which subjects will be randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups or to an untreated control group.

• Ophthalmologists at New York Eye and Ear Infirmary of Mount Sinai (NYEE) are warning not to look directly at the sun during the upcoming solar eclipse, on April 8, without taking essential precautions. Their warning comes after a unique case during the 2017 eclipse, when a Mount Sinai patient watched the eclipse for 20 seconds without proper eye protection. That patient ended up with permanent eye damage and was diagnosed with solar retinopathy. A study in JAMA detailed the patient’s eye damage: Within 4 hours, the patient developed blurry distortion in both eyes and could only see the color black. When specialists at NYEE examined her 3 days later, they found she had crescent-shaped retinal damage — the shape of the visible portion of the sun during the partial solar eclipse in New York City. They diagnosed her solar retinopathy and photochemical burns. She has permanent eye damage with no known treatment or cure. Researchers used high-resolution imaging technology to examine the damage on a cellular level and got an instant, detailed look at the damaged photoreceptors. 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.