FDA authorizes first device treatment for dry AMD

LumiThera announced that the FDA granted marketing authorization for its Valeda Light Delivery System, a photobiomodulation device, as a treatment for patients with dry AMD, making it the first FDA authorized device-based treatment. According to the company’s press release, Valeda treatment provides an improvement of 5 or more letters in BCVA over 24 months. The company submitted its pivotal trial data under a De Novo request with special controls. Valeda already has the CE Mark in the E.U. and is available in some Latin American countries.

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Fast track designation granted to retinopathy of prematurity prevention therapy

FELIQS received a Fast Track designation from the FDA for FLQ-101, a therapy intended to prevent retinopathy of prematurity. If successful, the once-daily oral/intravenous solution would be the first preventative treatment for this condition. According to the company’s press release, FLQ-101 “enhances the physiologic response of vascularization in [the] retina and protects from inflammation and abnormal neovascularization.” The therapy already has an Orphan Drug designation.

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Fluorescent hydrogel for cataract surgery

Researchers at Johns Hopkins University developed a fluorescent hydrogel for cataract surgery, intended to help surgeons see it better and thus ensure it all has been removed efficiently at the end of cases. The hydrogel, according to the university’s news article, is fluorescent green under blue light. More details about the ophthalmic viscosurgical device (OVD) were published in a paper in the Journal of Cataract & Refractive Surgery. The paper noted that the OVD was manufactured with fluorescein-conjugated hyaluronic acid.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is now open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
• ASCRS Live!: This educational dinner series has made its way to several cities across the U.S. in 2024. Registration is open for the events in Charlotte, North Carolina, on November 14 and Denver, Colorado, on December 5.
• ASCRS 50th anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

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Research highlights

• A prospective observational study published in the Journal of Cataract & Refractive Surgery is providing guidance for predicting changes in ocular dominance after cataract surgery. According to the study, which included 94 patients (188 eyes), 40.4% experienced an ocular dominance shift. Risk factors for this were determined to be age, UDVA of the non-dominant eye, posterior subcapsular cataract, and total astigmatism. The authors wrote that these findings could help improve IOL selection and monovision strategies. The authors also reported there was no difference in vision-related quality of life among patients who experienced ocular dominance shift compared to those who didn’t.
• A retrospective chart review published in the journal Clinical Ophthalmology evaluated visual outcomes and satisfaction after receiving a trifocal IOL in patients who had prior radial keratotomy (RK). The review included 14 eyes from 7 patients who had prior 8-cut RK and later cataract surgery with a trifocal IOL. Mean spherical equivalent went from +1.81±4.27 preoperatively to −0.41±1.2 D at the last follow-up visit; 29% of patients were within 0.5 D of targeted spherical equivalent and 86% were within 1 D. UDVA preop was 0.32±0.2 and 0.64±0.2 postop. DCNVA of 20/40 or better was achieved in 80% of patients. Two patients in the group reported “a lower degree of satisfaction” with their trifocal IOL vision. Glare and night vision were the most frequent complaints. The authors concluded that trifocal IOLs can be safe and effective for patients with RK, but factors such as “preoperative expectations, glare testing, refractive error, number of cuts, optical zone size, and visual phenomena related to RK, should be considered before implantation.”

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