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Ocuphire Pharma and Viatris Inc. announced the FDA approved RYZUMVI (phentolamine ophthalmic solution) 0.75% eyedrops for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tropicamide) agents. RYZUMVI is expected to be commercially available in the United States in the first half of 2024. RYZUMVI was evaluated in the comprehensive MIRA clinical trial program involving more than 600 subjects, including the MIRA-1 Phase 2b trial, MIRA-2 and MIRA-3 Phase 3 pivotal trials, and MIRA-4 Phase 3 pediatric trial.
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Apellis Pharmaceuticals announced the Centers for Medicare & Medicaid Services (CMS) assigned a permanent and product-specific J-code (J2781) for SYFOVRE (pegcetacoplan injection), the first-ever treatment for geographic atrophy secondary to AMD. The J-code for SYFOVRE will become effective on Oct. 1, 2023. The permanent J-code has been published by CMS here.
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Thea Pharma announced the launch of IYUZEH (latanoprost ophthalmic solution) 0.005% in the US market. IYUZEH is the first preservative-free latanoprost for patients with primary open-angle glaucoma and ocular hypertension in the United States. IYUZEH is available through authorized distributors and the following wholesalers and order numbers: ABC (10282592), ANDA (603442), Cardinal (5865035), McKesson (2849651) and NDC (82584-003-30). IYUZEH is available for $60 for a 30-day supply through programs with PhilRx and the Thea Savings Card. For more information and eligibility requirements, visit iyuzeh.com. In addition, Thea is providing a Patient Assistance Program for eligible US patients that have a demonstrated financial need and are without prescription insurance coverage.
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Bausch + Lomb announced the US launch of LUMIFY EYE ILLUMINATIONS, a new line of hypoallergenic specialty eye-care products scientifically developed to cleanse, nourish and brighten the sensitive eye area. The product line includes: LUMIFY EYE ILLUMINATIONS 3-in-1 Micellar Cleansing Water and Eye Makeup Remover, Nourishing Lash & Brow Serum and Hydra-Gel Brightening Eye Cream. Each product has been formulated with nutrient rich ingredients and contains no fragrance, alcohol, sulfates, mineral oil, prostaglandins, PEG (polyethylene glycol), parabens, phthalates or PHMB (polyhexamethylene biguanide). In addition, the safety and performance of the products were tested up to 12 weeks with more than 15,000 applications using cutaneous and ophthalmic testing metrics.
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Johnson & Johnson Vision announced the launch of Vision Made Possible, a global effort to raise awareness and ignite conversation about the importance of eye health across all ages and stages of vision. To capture the real-life stories of patients, Johnson & Johnson Vision is collaborating with Kate T. Parker, a professional photographer/director and New York Times best-selling author. Vision Made Possible will explore personal stories of patients around the world and physicians across various eye diseases — myopia, presbyopia, cataracts and others — to highlight how their life improved with better vision and educate others on the importance of comprehensive eye care.
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Real World Ophthalmology’s virtual meeting, titled “Top 10 Things I Wish I Knew Sooner!” will take place on September 30 from 8:00 a.m.-5:00 p.m. CST. The conference will feature keynote speakers Paul P. Lee, MD, JD, and Jane C. Edmond, MD, as well as leaders from seven major specialty societies and more than 70+ experts in the field. Attendees will have the opportunity to learn, engage and network. The event is free for all ophthalmologists in residency and fellowship through the first 10 years of practice. To register, click here.
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Researchers at the University of Toronto built an online simulator that gives an improved visual representation of the deterioration caused by glaucoma. The simulator depicts the disease from the patient’s perspective and is based on a data-driven model the researchers developed to help quantify glaucoma measurements. The model, which takes into consideration the physiological mechanism of the eye, was published in a paper in the journal Translational Vision Science & Technology. The online simulator allows the user to set the patient’s age range and control progression rates from a starting point of mild, moderate or severe. It then simulates the yearly progression of the disease through photos of people, landscapes and city scenes. The researchers next step is to combine different testing methodologies for glaucoma to shorten the time required to reliably detect its onset using machine learning methods.
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.