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Sight Sciences announced the US launch of the Ergo-Series of the OMNI Surgical System. The technology facilitates surgeons’ ability to perform minimally invasive, implant-free glaucoma procedures in adults with primary open-angle glaucoma. The Ergo-Series enables a minimally invasive glaucoma surgery that addresses the trabecular meshwork, Schlemm’s canal and the collector channels. It can be used before, in combination with or following cataract surgery. The system allows surgeons to easily rotate and position the cannula tip within Schlemm’s canal with precise finger rotations vs wrist adjustments. Additionally, the handle’s viscoelastic luer connector is now removable and detaches when the viscoelastic cartridge is removed, resulting in more clearance with the surgical microscope. The cannula tip also has a new profile that enables gentle and precise access to Schlemm's canal while continuing to enable full 360-degree catheterization associated with the OMNI procedure.
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Apotex Corp., with the knowledge of the FDA, issued a voluntary recall at the consumer level for six lots of brimonidine tartrate ophthalmic solution, 0.15% due to cracks that developed in some of the unit caps of the bottles. The broken cap may impact sterility and the possibility of adverse events. The six lots can be identified by NDC numbers stated on the carton and label of the product. The lots were distributed nationwide in the United States between April 5, 2022 to Feb. 22, 2023. Patients who have received the identified lots or have questions regarding the recall should contact their pharmacy and immediately contact their health-care provider for medical advice. Consumers with questions can also contact Apotex Corp. at 1-800-706-5575 or UScustomerservice@Apotex.com.
- Pharmedica USA, with the knowledge of the FDA, issued a voluntary worldwide recall of two lots of Purely Soothing, 15% MSM Drops due to non-sterility. Pharmedica is advising customers to immediately stop using the product and return it to the place of purchase. Consumers should contact their physician or health-care provider if they have experienced any problems that may be related to taking or using this drug product. Wholesalers and retailers should stop distributing/return to Pharmedica immediately or confirm that the product has been disposed of with proper verification. To date, Pharmedica has not received any reports of adverse events or illness related to this recalled product. Consumers with questions can contact Pharmedica at +1 (623) 698-1752 or osm@pharmedicausa.com.
- Eyebiotech Limited (EyeBio) announced details on its lead program, Restoret, the first asset in a diversified pipeline of multi-specific agonist antibodies. Restoret is a tri-specific Wnt agonist antibody designed to address urgent unmet medical need in patients with back-of-the-eye diseases. Restoret is the result of a breakthrough in antibody technology and will enable the clinical translation of the Wnt pathway for the first time in the eye. EyeBio plans to file for clinical trial authorizations to enable a global Phase 1b/2 clinical trial of Restoret in the second quarter of 2023. In addition, EyeBio has also in-licensed a second bispecific agonist antibody asset for the treatment of retinal diseases, with a separate and complementary mechanism of action to Restoret.
- Ophtec, a producer of IOLs based in Groningen, the Netherlands, is celebrating its 40th anniversary in 2023. Ophtec was founded by the Dutch ophthalmologist Professor Dr. Jan Worst, the inventor of the world’s first iris fixated IOL, the Artisan lens. As part of the company’s anniversary, it has launched a new brand identity that honors its heritage, freshens up its brand and connects to a new generation of eye doctors, said Marketing Manager Remko Bos via press release. The company also announced that it is introducing a new preloaded injector system for its Precizon cataract lenses.
- Cedars-Sinai investigators produced an extensive analysis of changes in the retina and how those retinal changes correspond to brain and cognitive changes in Alzheimer’s disease patients. Their analysis, published in Acta Neuropathologica, provides a step toward understanding the complex effects of Alzheimer’s disease on the retina, especially at the earliest stages of cognitive impairment. Investigators found an overabundance of a protein called amyloid beta 42, which in the brains of Alzheimer’s disease patients clumps together to form plaques that disrupt brain function. Additionally, they found an accumulation of amyloid beta protein in ganglion cells and higher numbers of astrocytes and immune cells, called microglia, tightly surrounding amyloid beta plaques. For more, see the study results here.
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