• Apellis Pharmaceuticals announced the FDA approval of SYFOVRE (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to AMD. SYFOVRE is the first FDA-approved treatment for GA. The drug is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians, with a dosing regimen of every 25 to 60 days. ApellisAssist is a program designed to help SYFOVRE patients by providing a system inclusive of insurance support, financial assistance for eligible patients, disease education and ongoing product support. Patients and health-care providers can call 1-888-273-5547 for more information. SYFOVRE is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide.

• Regeneron Pharmaceuticals reported that the FDA gave Priority Review status to its Biologic License Application (BLA) for aflibercept 8 mg for treatment of wet AMD, diabetic macular edema (DME) and diabetic retinopathy. The FDA target action date is June 27, 2023, following the use of a priority review voucher. The BLA is supported by data from two pivotal trials — PULSAR in wet AMD and PHOTON in DME — that were previously presented at the Annual Scientific Session of The Retina Society. In both trials, patients treated with aflibercept 8 mg (PULSAR n=673; PHOTON n=491) met the primary endpoint of non-inferiority in vision gains for both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to patients treated with an EYLEA (aflibercept) Injection (PULSAR n=336; PHOTON n=167) 8-week dosing regimen.

• Orasis Pharmaceuticals announced the FDA accepted for review its new drug application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%), a novel corrective eyedrop candidate being investigated for the treatment of presbyopia. The NDA is based on data from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of CSF-1. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity, and no loss of 1-line or more in distance visual acuity. The FDA assigned a Prescription Drug User Fee Act goal date of Oct. 22, 2023.

• In addition to EzriCare Artificial Tears, the CDC stated on its website that patients should also stop using Delsam Pharma’s Artificial Tears products pending additional information and guidance from CDC and FDA. The outbreak is associated with multiple types of infections, including eye infections. The investigation to date has identified artificial tears as a common exposure for many patients. As of Feb. 21, 2023, CDC, in partnership with state and local health departments, identified 58 patients in 13 states (CA, CO, CT, FL, IL, NJ, NM, NY, NV, TX, UT, WA, WI) with the outbreak strain, carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA), a rare strain of extensively drug-resistant P. aeruginosa. Thirty-five patients were linked to four health-care facility clusters. One person has died and there have been five reports of vision loss. Read the full statement here.

• Alcon announced the launch of the Alcon Experience Academy (AEA) app to help optimize physicians’ digital learning experiences. The new app underscores Alcon’s commitment to expanding remote, on-demand education and training to physicians worldwide. The customizable global platform offers more than 2,000 courses in 17 languages as well as newly launched podcasts and discussion forums on relevant eye-care topics, along with downloadable content. The AEA app can be downloaded from the Apple App Store or Google Play. For more information about the Alcon Experience Academy, visit AlconExperienceAcademy.com.

• Registration is now open for Compulink Healthcare Solutions’ Compulink Connected annual user conference, May 18-19, 2023, in San Diego. The conference brings together providers, executives, medical staff and other experts for an interactive live event. Attendees can acquire new skills and discover how industry trends affect their practices during two days of courses, workshops and round tables. In addition, attendees can partake in the company’s Advantage SMART Lab, where they can collaborate with company experts to get personalized support and provide feedback. To view the agenda and to register, click here.

• Clearside Biomedical announced several presentations were delivered at two medical conferences. At the Angiogenesis, Exudation, and Degeneration 2023 – Virtual Edition, data was presented on two key programs in wet AMD utilizing Clearside’s SCS Microinjector for suprachoroidal delivery. The results from Clearside’s OASIS Phase 1/2a clinical trial revealed CLS-AX showed 67% of participants in the Extension Study went at least 6 months without needing additional treatment, and 50% went beyond 6 months. Clearside’s partner, REGENXBIO, presented data from its Phase 2 AAVIATE clinical trial utilizing RGX-314, a gene therapy delivered via suprachoroidal injection to treat wet AMD. Results showed that suprachoroidal RGX-314 was well tolerated in cohorts 1-5 (n=85). At the Macula Society annual meeting, a summary was presented of the 6-month Extension Study results from Clearside’s CLS-AX OASIS Phase 1/2a clinical trial in participants with wet AMD. The results showed CLS-AX had an excellent safety profile and promising durability with a meaningful reduction in treatment burden across cohorts of between 77%-85%. Clearside’s OASIS full clinical trial data presentation can be accessed here, and medical meeting presentations can be accessed here.

• A team of researchers found early signs of damage in the eye before the onset of type 2 diabetes, suggesting that diabetic complications may start during the pre-diabetic state. The team, led by Professor Dr. Ali Hafezi-Moghadam, director of the Molecular Biomarkers Nano-Imaging Laboratory (MBNI), in collaboration with Professor Dr. Christoph Rußmann, dean of the Health Campus and a visiting professor at MBNI, published the results in the Journal of Biomedical Science. To unravel the origins of tissue damage in diabetes, the team conducted its studies in the Nile grass rat, a model that they originally reported spontaneously develops type 2 diabetes when kept in captivity and closely mimics the condition in humans. The advanced imaging technology used in this study helped them see for the first time, dot-like microlesions that would not have been visible otherwise. The newly found micro-lesions preceded all forms of diabetic cataract. 

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.