• The FDA approved Bausch + Lomb’s LUMIFY Preservative Free redness reliever eyedrops, the first over-the-counter (OTC) preservative-free eyedrop with low-dose OTC brimonidine tartrate for the treatment of ocular redness due to minor eye irritations. LUMIFY Preservative Free significantly reduces redness within 1 minute and lasts up to 8 hours, the company says. In clinical trials, LUMIFY Preservative Free was shown to have a low incidence of side effects, like rebound redness and loss of efficacy over time, when used as directed. Bausch + Lomb says it expects to make LUMIFY Preservative Free available for purchase at major retailers in early 2025 in single-use vials. 

• Bausch + Lomb also announced Frontiers in Ophthalmology published statistically significant results from a clinical study evaluating the efficacy and safety of a novel daily nutritional supplement formulated to address the symptoms of dry eyes. The clinical study met both primary endpoints: Change from baseline at day 56 (week 8) in tear production (Schirmer’s test); and change from baseline at day 56 in ocular symptoms measured by OSDI score. The study also met secondary endpoints, showing statistically significant improvements in tear-film break-up time, osmolarity, ocular surface health and presence of an inflammatory marker. Bausch + Lomb expects to launch the supplement, which features a proprietary blend of ingredients including lutein, zeaxanthin isomers, curcumin and vitamin D3, under the brand name Blink NutriTears early in the third quarter of 2024 in the United States. 

• AEYE Health received the first FDA clearance for AEYE Diagnostic Screening technology (AEYE-DS), a fully autonomous artificial intelligence (AI) that diagnoses referable diabetic retinopathy (DR) from retinal images obtained by a handheld camera. The portable solution is suited for point-of-care screening, enabling screenings in clinic or at-home. AEYE-DS is commercially available with a tabletop imaging device. AEYE-DS screens patients using just one image per eye with over 99% imageability. Screening for DR with AI is now reimbursable in using the newly approved AI CPT code 92229 for autonomous screening. Additionally, it serves as a major HEDIS measure for most health plans. 

• Eyenovia announced results from a Phase 4 study of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% designed to determine the efficacy and duration of effect of the lowest deliverable dose of Mydcombi for pupil dilation. Twenty-nine subjects were treated with a half dose of Mydcombi (8µL per eye) and evaluated at the end of 2023. At 30 minutes post dose, clinically relevant pupil dilation was achieved in approximately 67% of patients, and by 60 minutes, that percentage increased to 86%. In addition, the majority of patients returned to a pupil size of less than 5 mm between 3.5 and 6 hours post-instillation, with 93% reaching that point by 6 hours. Administering a lower 8 microliter volume was well tolerated with minimal adverse events reported. Mydcombi is the first FDA-approved product dispensed with the company’s Optejet technology. For more, see the study results here. 

• Prevent Blindness designated May as “Inherited Retinal Disease (IRD) Genetic Testing Awareness Month.” The group is providing a variety of tools to promote awareness and education for IRDs and the importance of genetic testing, including a free webinar, expert and patient videos, shareable social media graphics, and fact sheets in English and Spanish. Later in May, Prevent Blindness will establish a dedicated webpage, new fact sheets, an expert video and resources to provide education and support for those with Stargardt Disease. On May 29, at 2 p.m. EST, the National Center for Children’s Vision and Eye Health at Prevent Blindness will host the free webinar, “Pathway to Diagnosis: Genetic Testing for Inherited Retinal Diseases.” Additionally, as part of its Focus on Eye Health Expert Series, Prevent Blindness offers the episode, “Inherited Retinal Disorders and Genetic Testing.” For more information on these and additional resources, click here.

• Coave Therapeutics announced that preclinical studies on its novel Conjugated AAV (coAAV) gene therapy vectors demonstrate promising results for ocular gene therapy. Engineered coAAV vectors, generated using Coave’s ALIGATER platform, show the ability to increase both the distribution and expression patterns of transgenes delivered via suprachoroidal administration, effectively improving the targeting of key tissues at the back of the eye. This advancement suggests a new, potentially impactful approach for treating acquired retinal diseases. These data, generated in collaboration with REGENXBIO, will be presented at the upcoming 2024 American Society of Gene & Cell Therapy meeting.

• Lighthouse Guild received an AMDF Thrive Award of $75,000 from American Macular Degeneration Foundation to study the effectiveness of various assistive technology devices. The goal is to provide objective information that will help people with vision impairment determine which devices will work best for them. Working directly with a cohort of people with vision impairment, Lighthouse Guild is collecting data on the functionality, usability, accessibility and acceptability of specific devices. The data will be compiled to develop recommendations. According to AMDF, the findings from this study will ripple across the entire AMD community, helping patients quickly find assistive technology that meets their unique needs while allowing providers of low vision services to optimize their consultations.

• Emmetrope Ophthalmics (Emmecell) announced final dose administration for the last patient in its US randomized, double-masked, multi-center trial assessing the safety and efficacy of EO2002 for the treatment of corneal edema. EO2002 is a first-in-class, non-surgical cell therapy with the ability to modify disease via Emmecell’s Magnetic Cell Delivery nanotechnology platform. EO2002 offers the promise of a treatment for corneal edema without the need for invasive and high-risk surgical procedures such as corneal transplantation. Topline results from both trials are anticipated in the second half of 2024, with a Phase 3 pivotal study planned for the first quarter of 2025.


• Aurion Biotech completed dosing of all subjects in its Phase 1/2 clinical trial (CLARA) of AURN001, an allogeneic cell therapy for the treatment of corneal edema secondary to corneal endothelial dysfunction. The CLARA trial is designed to assess the safety, tolerability and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. The primary endpoint is the percentage of subjects who gain three lines of vision at 6 months. The study will evaluate three different doses of neltependocel (allogeneic human corneal endothelial cells) used in combination with Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase). AURN001 is intended to be administered to the eye as a one-time, intracameral injection.

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.