• Johnson & Johnson Vision’s ELITA Femtosecond Laser has received FDA 510(k) clearance for the creation of LASIK flaps. The ELITA Femtosecond laser features include low energy per pulse, fast laser repetition rate and small spot size (1µm), smooth stromal bed and sub-micron precision. Additionally, ELITA features an intuitive user interface, modular design and a quick system startup in less than 5 minutes. Also, it is designed to reduce complications, improve visual outcomes and enable fast visual recovery. ELITA will be unveiled at the ASCRS annual meeting and will be available to ophthalmologists across the United States later this year.

• The FDA approved the ZEISS CT LUCIA 621P Monofocal aspheric, single-piece C-loop IOL. The IOL features the patented ZEISS Optic Asphericity Concept, which is designed to compensate for a wide range of spherical aberrations and optimize visual outcomes in the event of potential decentration and lens misalignments. The IOL comes in a fully preloaded injector, and the architecture of the IOL is designed to enable easy centering while maximizing direct capsular contact, thus optimizing stability and supporting a consistent position in the bag. The CT LUCIA 621P Monofocal IOL will be showcased at the ASCRS annual meeting in San Diego.

• Bausch + Lomb announced the US launch of StableVisc cohesive ophthalmic viscosurgical device (OVD) and the TotalVisc Viscoelastic System. StableVisc and TotalVisc provide eye surgeons with new options for dual-action protection during cataract surgery. StableVisc, a cohesive OVD, helps maintain space in the anterior chamber of the eye to allow surgeons to extract and replace the clouded natural lens. TotalVisc includes both StableVisc and ClearVisc, a dispersive OVD, and protects ocular tissue during the surgical procedure.

• Lumibird Medical announced the launch of two additional variants within its premium Nd:YAG/SLT laser range: the Ultra Q Reflex Neo and Tango Neo. A fully integrated Q-switched Nd:YAG laser for anterior-segment YAG and glaucoma indications, Ultra Q Reflex Neo features second-generation Reflex technology with True Coaxial Illumination, enhancing visualization of anterior and posterior segments. Features include Imprint, a dynamic heads-up display with real-time view of treatment settings within the binoculars, joystick control of energy settings and up to 2 mm YAG posterior offset, facilitating Premium Refractive Outcome Capsulotomies (PROcap). Tango Neo has an improved general user interface with a modern look and feel and more intuitive control. Tango Reflex Neo, UltraQ Reflex Neo and Tango Neo are FDA 510K approved and will be on display at ASCRS.

• Medical Consulting Group (MCG), a provider of consulting services to ophthalmic practices and companies, and Corcoran Consulting Group (CCG), a company specializing in billing, coding and reimbursement issues for ophthalmology and optometry practices, announced a definitive merger agreement. MCG and CCG believe this merger will enhance the ophthalmic community by providing a broad range of ophthalmic consulting and educational services in the eye-care marketplace. Clients of both companies will have a larger team to draw upon to support the increasingly complicated back-office functions and regulatory compliance issues they face. Both companies will continue to operate under their current names.

• Apellis Pharmaceuticals announced post hoc analyses from the 24-month, Phase 3 OAKS and DERBY studies evaluating SYFOVRE (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to AMD. SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions (≥0.25 mm from the foveal center). Additionally, SYFOVRE showed a meaningful reduction in the loss of photoreceptor and retinal pigmented epithelial cells. In the 24-month analysis, SYFOVRE-treated patients compared to sham demonstrated: Preservation of 5.6 letters, equivalent to more than one line of vision on an ETDRS chart, as measured by BCVA; and a 4.1-point benefit in vision-related quality-of-life outcomes, as measured by the NEI-VFQ-25, a questionnaire that assesses outcomes, such as social function, driving and dependency on others. Four points is considered clinically meaningful.

• IVERIC bio released findings from exploratory analyses of data for avacincaptad pegol (ACP). A post-hoc analysis from the GATHER1 and GATHER2 pivotal Phase 3 clinical trials showed, for the first time in an interventional study in GA, a relationship between GA growth and worsening vision loss. In this combined analysis, greater vision loss was correlated with increased GA growth. The analysis from the trials signals that reduced rate of vision loss in patients receiving ACP was correlated with reduced GA growth. Additionally, post-hoc time-to-event analyses signal fewer patients receiving ACP had 10-, 15- and 20-letter losses from baseline at two consecutive visits up to 12 months compared to sham.

• Haag-Streit announced the Lenstar Myopia, a comprehensive solution for myopia management, now includes the Age-Matched Myopia Control (AMMC) framework by Dr. Hakan Kaymak. The AMMC framework provides data on the eye's expected length growth considering age, gender and sociocultural environment. Ophthalmologists can compare axial length growth speed to a broad demographic database and can observe and assess axial length growth over time and overlay potential treatments. This makes it possible to understand therapy effectiveness, allowing ophthalmologists to adjust the individual patient's therapy as required. AMMC can also help to uncover developing myopia based on excessive axial length growth before it becomes visible in refraction.

• RetinAI Medical announced a partnership with Boehringer Ingelheim. The companies aim to improve patient outcomes in GA by combining RetinAI’s Discovery platform and artificial intelligence tools with Boehringer Ingelheim’s research in retinal diseases. RetinAI’s tools for identifying novel biomarkers will be tested for the analysis of Boehringer Ingelheim’s imaging datasets from clinical studies and real-world evidence to identify additional, novel biomarkers and predictors of disease progression. This integration of digital technologies and AI could help accelerate the development of needed novel treatments and enable earlier and more precise diagnosis.

• Atsena Therapeutics announced positive 6-month safety and efficacy data from the ongoing Phase 1/2 clinical trial of ATSN-101, the company’s investigational gene therapy for the treatment of GUCY2D-associated Leber congenital amaurosis. Among patients who received the high-dose treatment, the mean change from baseline in retinal sensitivity by dark-adapted full-field stimulus testing was significantly greater in treated eyes compared with untreated eyes at Day 28 and all subsequent follow-up visits. Two high-dose patients demonstrated BCVA improvement greater than 0.3 logMAR, and no treated eyes had a decrease in BCVA. Of the five high-dose patients who were tested with the MLMT mobility test, four patients demonstrated either a maximum MLMT score of 6 or a ≥2 level improvement, compared to baseline when available or to the untreated fellow eye, at one or more post-treatment visits. 

• Trefoil Therapeutics announced a series of data presentations demonstrating the potential use of TTHX1114 to protect endothelial cells. The company also announced the completion of the Phase 1 epithelial study designed to assess the safety and dosing profile of TTHX1114 in a topical eyedrop formulation for epithelial conditions. A data update from the Phase 2 STORM study, which evaluated the potential use of TTHX1114 as a way to protect endothelial cells from damage due to cataract surgery in Fuchs endothelial corneal dystrophy patients undergoing Descemet stripping only (DSO), was also presented. Across all patients, TTHX1114 produced a dose-dependent response in resolution of corneal edema and improvement of BCVA following surgery; and the proportion of patients with complete resolution of corneal edema in the high-dose groups at 28 days after surgery was similar in patients with DSO vs those with DSO and cataract surgery. The abstracts are available here.

• OKYO Pharma announced the activation of the first clinical trial site in the United States for its Phase 2, multi-center, randomized, double-blinded, placebo-controlled trial evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with dry eye disease (DED). OK-101 was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating DED. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of DED and corneal neuropathic pain. It is designed to combat washout through the inclusion of the lipid “anchor” contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment. 

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.