Voluntary IOL recall

Bausch + Lomb announced the voluntary recall of IOLs on its enVista platform, including enVista Aspire, enVista Envy, and certain enVista monofocal IOLs. In a press release the company stated that the recall is “out of an abundance of caution” after reports of an increased number of toxic anterior segment syndrome (TASS) cases that were “in conjunction with implantation of the enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.” The company stated that the reports are a small percentage of implanted cases and that they have all had a positive prognosis. The company is working to identify the root cause.

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Phase 4 study assesses patient-reported outcomes of dry eye drop

Bausch + Lomb announced publication of results from a Phase 4 study that evaluated patient-reported outcomes with MIEBO (perfluorohexyloctane ophthalmic solution). The study, according to the company’s press release, was prospective, multicenter, open label, and evaluated the effect of MIEBO on symptom severity and frequency in early treatment among patients who had a history of dry eye disease and meibomian gland dysfunction. Patients completed outcome surveys on day 1 (before treatment and at 5 and 60 minutes after the first drop administration) and at days 3, 7, and 14. The visual analog scale from 0 to 100 was used to rate symptom severity, symptom frequency, and treatment satisfaction. The study found that the drop significantly reduced overall symptom severity at day 7, provided significant symptom relief within 5–60 minutes after one drop administration, and provided significant reductions in symptom severity among all symptoms of dryness, blurred vision, irritation, light sensitivity, and burning/stinging, among others. These and other findings were published in the journal Ophthalmology and Therapy.

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Study: synthetic opsin restores vision in cases of severe retinal degeneration

Nanoscope Therapeutics announced publication of its Phase 1/2 trial in the journal Molecular Therapy, showing restoration of vision in patients with severe retinal degeneration. According to the study, a broadband multi-characteristic opsin (MCO-010) was given via an intravitreal gene therapy injection to four patients who were blind from retinitis pigmentosa with ABCA4 variants. Noninvasive imaging, according to the investigators, showed retinal gene expression, and patients showed “improvement in vision, shape discrimination, and mobility through 52 weeks.” The authors reported no significant safety concerns and wrote that “this is the first report of a gene monotherapy that can restore vision in blind patients in a mutation-independent manner utilizing an optogenetics technology platform.” The company, in its press release about the study, included that it previously announced plans to begin a BLA submission for MCO-010 to treat retinitis pigmentosa in the first quarter of this year. It also announced that it has completed its Phase 2 trial of the therapy for patients with Stargardt disease and plans to begin a Phase 3 registrational trial this year. MCO-010 has a Fast Track Designation and an Orphan Drug Designation from the FDA for retinitis pigmentosa and Stargardt disease.

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Phase 3 endpoints not met in trial evaluating wet AMD treatment

Opthea announced that its Phase 3 trial evaluating OPT-302 (sozinibercept, 2 mg) administered every 4 or 8 weeks in combination with 2 mg aflibercept every 8 weeks for treatment of wet AMD did not meet its primary endpoint (mean change in BCVA from baseline at week 52). In a press release the company also noted “no numerical difference observed in the key secondary endpoints.” The company reported that discussions are underway to determine next steps.

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Merger news

• Alcon and LENSAR entered into a definitive merger agreement for Alcon to acquire LENSAR. According to Alcon’s press release, the acquisition of LENSAR’s ALLY Robotic Cataract Laser System “strengthens Alcon’s cataract equipment and technology portfolio.” The transaction is expected to close in mid- to late 2025, pending closing conditions and approvals.
• Alcon announced that it acquired majority interest in Aurion Biotech. A press release stated that Aurion would operate as a separate company with support of Alcon as it advances its clinical-state allogenic cell therapy asset, AURN001.
• Eyenovia announced a proposed merger with Betaliq that would create a new ophthalmic company combining Betaliq’s EyeSol, a water-free drug delivery technology used in glaucoma, and Eyenovia’s Optejet dispensing platform. The proposed merger is still subject to several terms of completion.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California. Find the most up-to-date information on the Real-Time Program here.
• SightLine at ASCRS: This is a new day-long meeting April 24, ahead of the ASCRS Annual Meeting, for all commercial stakeholders in ophthalmology to learn about and collaborate on technologies and care delivery ideas that will forge a more sustainable financial future. Learn more.
• Business of Interventional Glaucoma: Surgeons and practice administrators alike are invited to the ASOA ASCRS Business of Interventional Glaucoma program, taking place Thursday, April 24 from 1:00–5:30 p.m. in Los Angeles ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.
• 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. Tune in each week through April 2025 for a new video.

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Research highlights

• The safety and efficacy of customized femtosecond laser-assisted corneal allogenic intrastromal ring segments (CAIRS) in patients with keratoconus who had a prior history of intrastromal corneal ring segments (ICRS) that were explanted was evaluated in a prospective case series published in the Journal of Cataract & Refractive Surgery. The case series included 8 patients with keratoconus who had stable disease and ICRS explantation at least 6 months prior to the study. Customized CAIRS were created and implanted, and patients were followed up for at least 6 months postop. The authors wrote that the mean reduction in “maximum, mean, and steep central keratometry was 3.03 ± 1.35 diopters (D) (P=.01), 2.88 ± 2.51 D (P=.02), and 2.41 ± 2.72 D (P=.04), respectively.” Mean spherical equivalent and refractive astigmatism was also reduced. They noted that all eyes included in the study, except one, gained 2 or more lines of CDVA. Five patients were able to achieve a CDVA of 20/40 or better. There were no reported intraoperative or postop complications. The investigators concluded that femtosecond laser-assisted CAIRS was effective and safe for patients who had previous ICRS that were explanted.
• A retrospective study evaluated efficacy of a decellularized dehydrated amniotic membrane basement membrane (AMBM) used with eyelid pressure patching postop for treatment of persistent corneal epithelial defects. The study, which included 144 eyes treated with either a single-layer AMBM or a three-layer AMBM with 24-hours of eyelid pressure patching in the immediate postop period, found that the treatment was a safe and effective method of healing. More specifically, the single-layer group achieved 100% healing and AMBM dissolution. The three-layer group achieved a 100% improvement in corneal staining, though 20–30% of the AMBMs remained undissolved. There were no reports of patient pain, discomfort, or infection. This study was published in the journal Ophthalmology and Therapy.

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Product news

• TRIESENCE (triamcinolone acetonide injectable suspension, 40 mg/mL, Harrow) received CMS transitional pass-through status, making it eligible for separate reimbursement outside of the surgical-bundled payment in ASC and HOPD settings beginning April 1 and for the following 3 years.
• Alcon’s Clareon Vivity IOL received the CE Mark and will begin a commercial rollout in Europe in the second quarter of 2025.

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