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Brassica Pharma Pvt. Ltd. based in Thane, Maharashtra, India, issued a statement that it is voluntarily recalling four eye ointment products — Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment and Lubricant PM Ointment — with expiration dates ranging from Feb. 2024 to Sept. 2025. The products are being recalled due to lack of sterility assurance during an inspection conducted by the FDA, the company says. These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals. The company says there is a potential risk of eye infections or related harm and that consumers should stop using the recalled ointments. To date, Brassica says it has not received any reports of adverse events up to Feb. 16, 2024, related to this recall. Consumers with questions can contact Brassica Pharma Pvt. Ltd. at +1 833-225-9564 or info@brassicapharma.com. 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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program. Complete and submit the report online. Regular mail or fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. For more, click here.
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CoFi Inc. announced that patient payments with the CareCredit credit card, a Synchrony solution, can now be processed through CoFi’s multi-party payments platform. This market-wide availability follows a successful beta period involving joint CoFi and CareCredit customers. With CareCredit integrated into CoFi patients can now finance the entire cost of a procedure with CareCredit — including the surgeon’s fees and those of their surgical partners, such as the ASC and/or co-managing provider — right through the surgeon’s office. Funds are distributed compliantly to each provider, and there is no requirement that the surgical partners are enrolled with CareCredit.
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Skye Bioscience dosed 56 patients using SBI-100 Ophthalmic Emulsion (OE) in its Phase 2a study and completed final study visits for all patients. SBI-100 OE is a cannabinoid receptor type 1 agonist administered topically onto the eye and is being developed to address the unmet needs of patients with elevated IOP related to primary open-angle glaucoma or ocular hypertension. All treated patients completed the study, with no early discontinuations due to adverse events. Topline data for the entire study will be available in Q2. To learn more about the study, click here.
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Prevent Blindness launched the new “Retinopathy of Prematurity Education and Support Program,” as part of its first Retinopathy of Prematurity (ROP) Awareness Week, declared Feb. 26-March 3, 2024. The group is offering a variety of free educational resources to the public and professionals, including fact sheets, social media graphics in English and Spanish, dedicated online resources, and a new video series. Working with partners Hand to Hold, the National Coalition for Infant Health, and the SPAN Parent Advocacy Network, Prevent Blindness led the creation of a variety of expert-approved resources to educate parents and professionals on ROP. Prevent Blindness offers a dedicated ROP webpage, along with a three-part series of comprehensive fact sheets. Also available is the “Retinopathy of Prematurity” video in the Prevent Blindness Focus on Eye Health Expert Series. In addition, Prevent Blindness recently conducted a roundtable discussion, “Your Child and Retinopathy of Prematurity,” that has been adapted into a video series and is available on the Prevent Blindness website. For more information, click here.
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Researchers at the University of California, Irvine discovered profound similarities and surprising differences between humans and insects in the production of the critical light-absorbing molecule of the retina, 11-cis-retinal (or visual chromophore). The findings deepen the understanding of how mutations in the RPE65 enzyme cause retinal diseases, especially Leber congenital amaurosis. The researchers used X-ray crystallography to study NinaB, a protein found in insects that functions similarly to the RPE65 protein found in humans. The study found that structurally, these enzymes are very much alike, but the locations in which they perform their activity are different. Understanding key features within the NinaB structure has led to an enhanced understanding of the catalytic machinery necessary to support the function of the retinal visual pigments. Through the study of NinaB, the researchers were able to learn about the structure of a key portion of RPE65 that had not previously been resolved. This discovery is vital in understanding and addressing loss-of-function mutations in RPE65. For more information, see the study results here.
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A new international study in mice led by researchers at UCL and Moorfields shows that sight loss in certain inherited eye diseases may be caused by gut bacteria and is potentially treatable by antimicrobials. In eyes with sight loss caused by a particular genetic mutation, gut bacteria were found within the damaged areas of the eye. The findings suggest that the genetic mutation may relax the body’s defenses, thus allowing harmful bacteria to reach the eye and cause blindness. Using mouse models, the researchers discovered the CRB1 gene is key to controlling the integrity of the lower gastrointestinal tract. The team found that when the gene has a particular mutation, dampening its expression, the barriers in both the retina and the gut can be breached, enabling bacteria in the gut to move through the body and into the eye, leading to lesions in the retina that cause sight loss. Treating these bacteria with antimicrobial agents, such as antibiotics, was able to prevent sight loss in the mice even though it did not rebuild the affected cell barriers in the eye. Future work will investigate whether this mechanism and potential treatment applies in humans. 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.