FDA warns against copycat eye drops

The FDA issued a consumer warning against copycat eye drops that could be mistaken for Lumify (Bausch + Lomb), which is an over-the-counter drop approved to treat eye redness. The copycat drops named by the FDA are South Moon, Rebright, and FivFivGo. The FDA notes that these drops are “unapproved drugs and should not be approved for sale in the U.S.” The FDA stated that agency-tested samples revealed bacterial contamination in some of these drops, though it noted that there have not been any reported adverse events that specifically name these brands. It has, however, received reports related to “fake Lumify.”

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Generic drop receives FDA approval

Lupin announced that the FDA approved its abbreviated New Drug Application for bromfenac ophthalmic solution, 0.075%, as a generic equivalent to BromSite Ophthalmic Solution (Sun Pharma), 0.075%. This drop is indicated, according to the company, for treatment of postop inflammation and prevention of pain for patients having cataract surgery.

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Topline data revealed in two presentations

EyePoint Pharmaceuticals announced new subgroup analysis from its topline data from its Phase 2 trial EYP-1901 as a treatment for wet AMD. EYP-1901 is a sustained delivery of vorolanib, which the company describes as a tyrosine kinase inhibitor delivered via the bioerodible Durasert implant. Presentations made at the Angiogenesis, Exudation, and Degeneration 2024 Meeting revealed that a subgroup of patients were supplement-free up to 6 months after receiving EYP-1901and had a greater change in BCVA compared to the aflibercept control group. According to the company’s press release, full 12-month Phase 2 data and the beginning of a Phase 3 trial are expected in the second half of this year.

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New 72-week data from Phase 3 RVO treatment studies

Genetech announced 72-week data from its two Phase 3 studies evaluating Vabysmo (faricimab-svoa) in the setting of macular edema due to branch and central retinal vein occlusion. According to the company’s press release, nearly 60% of people in the Vabysmo group in one study and 48% in the other, extended treatment intervals, beyond the typical 1–2 months, to 3–4 months apart with the investigational treatment. The press release also reported vision gains and retinal drying was achieved in the first 24 weeks and maintained for more than a year. The drug was well tolerated, and the safety profile similar to that reported in previous studies.

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First patient dosed in Phase 2/3 trial for GA treatment

Aviceda Therapeutics announced that the first patient was dosed in part 2 of its Phase 2/3 trial of AVD-104 for treatment of geographic atrophy (GA). According to the company, this part of the trial is expected to enroll about 300 patients who will be randomized to receive one of two AVD-104 doses (a low dose or a high dose) or the comparator (avacincaptad pegol). This trial is multicenter, double masked, randomized and controlled. Patients will be dosed for 12 months with the opportunity to continue for another 12 months. The primary endpoint is the difference in growth rate of GA area measured by fundus autofluorescence. Other functional and anatomic measures will be compared as well. The company describes AVD-104 as “a promising intravitreal glycan-coated nanoparticle with a dual mechanism of action that modulates critical inflammatory cellular and complement pathways.”

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ASCRS news and events

• ASCRS Annual Meeting: The ASCRS Annual Meeting has something for everybody, from symposia to courses and paper sessions to hands-on lab experiences to networking opportunities. See what to expect April 5–8 in Boston, Massachusetts, by reviewing the ASCRS ASOA Preview Program.
• ASCRS Foundation: The 2024 ASCRS Foundation Chang-Crandall Humanitarian Award recipient is Martin Spencer, MD. Read more about Dr. Spencer and his inspiring work in this press release.

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Research highlights

• The long-term visual and anatomical outcomes of sutured scleral-fixated IOLs were evaluated in a retrospective, interventional, noncomparative study published in the Journal of Cataract & Refractive Surgery. The study included 64 eyes of 53 patients with a follow-up of 11.4±1.2 years. Mean preop CDVA was 0.71±0.43 logMAR and mean postop at the final visit was 0.52±0.49 logMAR. The authors reported that 48% had a CDVA of 6/12 or better at the last follow-up visit, and 58% had other ocular pathology affecting their visual outcomes. Seventeen percent of cases had IOL decentration, 14% IOL drop, and 6% suture exposure. IOL survival was 90.6% at 8 years postop and 81.2% at 10 years postop. The authors reported that postop IOL-related complications were not affected by patient sex, age, reason for initial surgery, previous intraocular surgery, or scleral fixation technique.
• The refractive outcomes and quality of vision of multifocal IOLs in the setting of high myopia (an axial length greater than 26 mm) was reported in a study published in Clinical Ophthalmology. The study included 50 eyes of 28 patients. Mean follow-up was 5.4±1.0 years. From 1-month postop to the last follow-up visit in these eyes, there was a decrease in UCVA from 0.14±0.13 to 0.08±0.09 logMAR, a negative increase in spherical equivalent from −0.31±0.60 to −0.02±0.20, and no change in BCVA. Near visual acuity of at least J2 was achieved in 89% of eyes 1-month postop and in 91% of eyes at the last follow-up. Most patients (91%) reported some near vision difficulty and 74% reported photic phenomena, but most did not find either bothersome. Eight-seven percent of patients at the last follow-up were at least “fairly satisfied” with their surgery.

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Product news

• Toku received the CE and UKCA Marks for its CLAiR technology, which uses retinal imaging and artificial intelligence to assess risk for cardiovascular disease.

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