• Outlook Therapeutics announced the FDA issued a Complete Response Letter to the company’s Biologic License Application (BLA) for ONS-5010 (Lytenava), an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

• Prevent Blindness released new annual data that shows there were more than 32,000 sports-related eye injuries treated in the United States last year, an increase of almost 20% from the previous year. To educate the public on the risk of significant and potentially blinding eye injuries and the need for proper eye protection, the organization declared September Sports Eye Safety Month. In addition to providing free downloadable fact sheets, shareable social media graphics, and a dedicated webpage, Prevent Blindness is debuting a new episode in the online Focus on Eye Health Expert Series, “Sports Eye Safety.” In addition, Prevent Blindness and Rec Specs (Liberty Sport) are partnering during Sports Eye Safety Month to promote education and awareness on ways to protect vision. To download free educational and promotional materials, including the Sports Eye Safety Guide from Liberty Sport, visit LibertySport.com/resources. 

• Atsena Therapeutics announced the first patient has been dosed in its Phase 1/2 open-label, dose-escalation and dose-expansion clinical trial, the LIGHTHOUSE study, evaluating subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). The trial is evaluating the safety and tolerability of ATSN-201 in male patients ages 6-64 with a clinical diagnosis of XLRS caused by pathogenic or likely pathogenic mutations in RS1. ATSN-201 leverages AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment.

• According to new research led by scientists at the University of Pittsburgh and Mass Eye and Ear, and published in the journal BMJ Oncology, relatively short-term use of immunosuppressant medications to control an inflammatory disease was not associated with an increased risk of later developing cancer. The study evaluated cancer risk for people with non-infectious ocular inflammatory diseases taking immunosuppressants. The research team tracked each participant in the study for an average of 10 years after they took immunosuppressant medications, or for a similar amount of time for those not taking immunosuppression, to see if they ever developed cancer. Four different categories of immunosuppressants — TNF-inhibitors, antimetabolites, alkylating agents and calcineurin inhibitors — were covered by the study, with some patients taking more than one type. Across all four classes of immunosuppressant medications the scientists found no evidence of excess risk of cancer in patients who took them on a short-term basis, regardless of medication dose.

• NEI Researchers successfully transplanted human microglia cells into mouse retina to create a model that could be used to test new treatments for incurable eye diseases. The researchers grew microglia from a type of stem cell called human induced pluripotent stem cells (hiPSCs). They conducted a series of tests to check that their cultivated microglia cells functioned as typical immune cells and then transplanted them into mice retina. At 4 and 8 months after transplantation, the human microglial cells had migrated into the retina and were well distributed — responding to chemical signals within the eye. The introduction of hiPSC-microglia cells had no negative effects on the surrounding cells of the retina. The team also tested whether the transplanted cells had a normal immune reaction to retinal cell injury and found that the cells behaved exactly as the resident mouse microglia. Not only did the transplanted microglia move into the damaged regions, but they also hoovered up the damaged light-receiving cells. This further suggests that the transplanted cells mirrored normal functions of resident microglia in the eye. For more, see the study results here. 

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