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FDA accepts NDA for dry eye nasal spray

The FDA has accepted a new drug application from Oyster Point Pharma for OC-01, a nasal spray treatment for the signs and symptoms of dry eye disease, according to a press release. The submission for OC-01 (varenicline) is supported by positive safety and efficacy data from the phase 3 ONSET-2, the phase 2b ONSET-1 and the phase 2 MYSTIC clinical trials, in which more than 1,000 patients with dry eye disease demonstrated significantly significant improvement in Schirmers score compared with cont...

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New prostaglandin shows high efficacy for lowering IOP

Patients treated with Vyzulta for open-angle glaucoma and ocular hypertension had significantly better outcomes compared with most beta-blockers, according to results of a systemic review and network meta-analysis. The objective of this study was to assess the relative efficacy of a new IOP-lowering medication, [Vyzulta], compared with other topical medications for the treatment of POAG [primary open-angle glaucoma] and [ocular hypertension (OH)] and to provide a relative ranking of these treatm...

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Ophthalmic innovator George Marcellino dies

George Marcellino, PhD, vice president of clinical affairs and marketing at Iridex, died unexpectedly on Feb. 10, according to a statement released by the company. Marcellino served on the Iridex board of directors for 3 years before becoming vice president in 2018. Before joining Iridex, Marcellino co-founded OptiMedica, where he led the development of pattern scanning laser photocoagulation for retinal disease treatment and the Catalys femtosecond laser cataract system. He spent more than 35 y...

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Anterior uveitis often associated with Zika virus infection

Anterior uveitis may be present in a high percentage of patients infected by Zika virus and is often associated with increased IOP, according to a study. Zika virus (ZIKV) infection is transmitted by Aedes mosquitoes. The first cases were reported in Uganda and Tanzania in the late 1940s, and in subsequent years, outbreaks were identified in several other African and Asian nations, Pacific islands and, later, several countries within Latin America and the Caribbean. Ocular manifestations reporte...

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Bio-Tissue pursuing investigational new drug for dry eye treatment

Bio-Tissue can proceed with a phase 2 study investigating morselized cryopreserved amniotic membrane and cryopreserved umbilical cord following clearance from the FDA, according to a press release. TTBT01 is being studied to support regenerative healing in dry eye disease. Because it is a section 351 biologic investigational new drug, TTBT01 will undergo a strict FDA preapproval process involving two randomized phase 3 clinical trials demonstrating safety and efficacy, the release said. Our lead...

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Glaucoma studies to establish screening, intervention guidelines

Three universities received funding from the CDC for their respective 5-year SIGHT studies investigating best practices to improve glaucoma screenings and intervention in vulnerable communities. By targeting vulnerable populations at high risk for glaucoma, specifically African Americans over age 40 years, Asians, older people (aged 65+ years) especially older Hispanics, those with a family history of glaucoma and those with diabetes, we can improve detection of glaucoma, C. Gustavo De Moraes, M...

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VIDEO: Pandemic intensifies need for paramedical support

In this video, David Spalton, MD, speaks about a session he co-chaired at the virtual European Society of Cataract and Refractive Surgeons winter meeting, focusing on paramedical support. The growing demands due to the aging of the population, as well as the current pandemic situation, have intensified the adoption of shared care models in the United Kingdom that include not only the involvement of optometrists and orthoptists in clinical tasks, but also the training of nurses to perform YAG cap...

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