• The FDA is warning consumers not to purchase or use South Moon, Rebright or FivFivGo eyedrops because of the potential risk of eye infection. These are copycat eyedrop products that consumers can easily mistake for Bausch + Lomb’s Lumify brand eyedrops. South Moon, Rebright and FivFivGo eyedrops are unapproved drugs and should not be available for sale in the United States, the FDA says. They claim to treat eye conditions such as glaucoma, which is treated with prescription drugs or surgery. The origin of these products is currently unclear, and the FDA is continuing to investigate. South Moon is labeled as made by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China. The FDA has not received any adverse event reports that specifically name the South Moon, Rebright or FivFivGo products. However, the agency has received reports related to possibly fake Lumify, including product quality concerns, eye irritation, pain and infection. Patients who have signs or symptoms of an eye infection should talk to their health-care provider or seek medical care immediately. Health-care professionals and consumers should report adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online at MedWatch Online Voluntary Reporting Form or Download and complete the form, then submit it via fax at 1-800-FDA-0178. For more, click here.


• Genentech, a member of the Roche Group, announced new 72-week data from two global Phase 3 studies, BALATON and COMINO, evaluating Vabysmo (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). The data showed nearly 60% of people receiving Vabysmo in BALATON and up to 48% of people in COMINO were able to extend their treatment intervals to 3 or 4 months apart. In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year. In both studies, Vabysmo was well tolerated, and the safety profile was consistent with previous studies. Both studies evaluated the average change in BCVA score from baseline. The studies also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness. Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks. For more, see the study results here. 

• 4D Molecular Therapeutics announced positive interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet AMD patients with severe disease activity and a high treatment burden. Fifty-one wet AMD patients with severe disease activity (mean of 442 µm central subfield thickness and presence of retinal fluid) and high treatment burden (mean of 10 anti-VEGF injections in preceding 12 months) were randomized to high (3E10 vg/eye) or low (1E10 vg/eye) dose 4D-150 or aflibercept control regimen. 4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up: no significant inflammation was observed (including no Grade ≥1+ inflammation in high dose patients) and all patients remained off topical steroids. Also, high dose 4D-150 resulted in an 89% reduction in the annualized anti-VEGF injection rate; 84% of patients received zero or one injection, and 63% were injection-free through 24 weeks. In addition, visual acuity and central subfield thickness were both stable vs aflibercept. 

• Kiora Pharmaceuticals entered a strategic development and commercialization agreement with Théa Open Innovation (TOI), a sister company of Laboratoires Théa. Under the agreement, Kiora granted TOI exclusive worldwide development and commercialization rights, excluding Asia, to KIO-301 for the treatment of degenerative retinal diseases. In exchange, Kiora will receive an upfront payment of $16 million; up to $285 million upon achievement of pre-specified clinical development, regulatory and commercial milestones; tiered royalties of up to low 20% on net sales; and reimbursement of KIO-301 research and development expenses. The strategic partnership covers retinitis pigmentosa and potentially other indications in ophthalmology across all global geographies, excluding China, Japan and certain other countries in Asia. Kiora is primarily responsible for the design and implementation of clinical development through Phase 2. Théa will assume primary responsibility for Phase 3 clinical trials as well as for securing regional marketing authorizations. Upon approval in respective regions, Théa will be responsible for all commercial activities including sales, marketing and market access.


• The ASCRS Foundation announced Martin Spencer, MD, as the distinguished recipient of the 2024 ASCRS Foundation Chang-Crandall Humanitarian Award, an award that recognizes and celebrates exceptional contributions to humanitarian work in the field of cataract blindness and disability. Dr. Spencer, through years of dedicated service, has collaborated extensively with Seva Foundation and Seva Canada, contributing significantly to humanitarian efforts in Nepal and many other countries worldwide.

• Aviceda Therapeutics dosed the first patient in Part 2 of the Phase 2/3 SIGLEC trial for AVD-104 in patients with geographic atrophy (GA) secondary to AMD. Part 2 of the SIGLEC trial is a multi-center, double-masked, randomized, controlled trial that will assess safety and efficacy outcomes of AVD-104 and an active comparator (avacincaptad pegol) for the treatment of GA secondary to AMD. Patients will be dosed for 12 months, with the opportunity to remain in the study for an additional 12 months. Those assigned to treatment with AVD-104 will receive low-dose AVD-104, high-dose AVD-104 or the active comparator. The primary endpoint will be the difference in growth rate of the GA area in patients treated with AVD-104 vs those receiving active comparator at 12 months as measured by fundus autofluorescence. Other visual functional and anatomic efficacy measures will also be explored and compared between AVD-104 and the active comparator. Part 2 of SIGLEC is expected to enroll approximately 300 patients. For more on the Phase 2/3 SIGLEC trial, click 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.