IN THE NEWS

The FDA issued a warning for consumers not to purchase and to immediately stop using 27 over-the-counter eyedrop products due to the potential risk of eye infections that could result in partial vision loss or blindness. The products are marketed under the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up, Velocity Pharma and Walmart Equate.

Orasis Pharmaceuticals announced the FDA approved QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is a prescription eyedrop that can be used daily, or as needed, up to twice per day. QLOSI is expected to be commercially available in the United States in the first half of 2024.

The FDA approved Genentech’s Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication for Vabysmo, in addition to wet, or neovascular, AMD and diabetic macular edema. The approval is based on positive results from the global Phase 3 BALATON and COMINO studies.

Heidelberg Engineering announced FDA clearance of its ANTERION platform that combines biometry, IOL power calculation with corneal topography and tomography, anterior chamber metrics, and high-resolution imaging.

Bausch + Lomb launched enVista Aspire monofocal and toric IOLs with Intermediate Optimized optics in the United States. In addition, Bausch + Lomb announced the US launch of SeeNa, an ophthalmic diagnostic system for refractive cataract patients that is fully integrated with its Eyetelligence surgical planning software. Also, a new surgical planning software for the Eyetelligence platform was introduced.

ZEISS Medical Technology announced digital enhancements to the cataract, corneal refractive and retina workflows as part of the ZEISS Medical Ecosystem. The VISULAS yag therapeutic laser received 510k clearance by the FDA. Additionally, the ZEISS AI IOL Calculator on the VERACITY Surgery Planner can now calculate the ZEISS CT LUCIA 621P IOL. ZEISS is also launching PROSPARA, a digital marketing cloud-based software solution.

Topcon Healthcare introduced the TEMPO Perimeter for fast and accurate visual field testing that can also function in ambient light. TEMPO’s binocular feature can test the right and left eyes separately and can randomly present the test object to either eye in a nonocclusion manner without the examinee being aware of which eye is being tested. TEMPO can be connected to Topcon’s Harmony image and data management solution.

ModMed announced the availability of a single-screen SOAP note into EMA that allows ophthalmologists to streamline their workflow. Reviewing a patient’s medical history, documenting findings and plans, and editing when needed are all handled on a single screen, reducing the need to click and scroll through various sections of the EHR in order to document a clinical visit.

EyeMD EMR launched Axon, a third-generation patient engagement system that allows clinicians to digitally interact with their patients outside of the clinical setting to enhance quality of care. Patient-captured images and clinical data are used to create workflow efficiencies.

The FDA granted Breakthrough Device designation to Toku Inc.’s patented AI-powered CLAiR technology. If cleared, the CLAiR platform will be the first medical device in the US market that can provide point-of-care and non-invasive evaluation for risk of cardiovascular disease using fundus retinal images through a routine eye exam, the company says.

Aldeyra Therapeutics entered into an exclusive option agreement with AbbVie Inc. Under the terms of the option agreement, AbbVie has the option to acquire a co-exclusive license to develop, manufacture and commercialize reproxalap in the United States and an exclusive license to develop, manufacture and commercialize reproxalap outside the United States.

LENSAR Inc. announced a step forward in its plans to integrate phacoemulsification technology from Oertli Instrumente AG into the ALLY Adaptive Cataract Treatment System. Oertli filed a 510(k) with the FDA for its Faros easyPhaco device, which would bring LENSAR closer to delivering combined femto phaco technology.