Check out the new EyeWorld Onsite

Live coverage from key sessions and events at the 2025 ASCRS Annual Meeting is already being featured on the new www.eyeworldonsite.org website. Keep up with timely and expanded coverage from in and around the ASCRS Annual Meeting with EyeWorld Onsite.

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IOL returns to market after brief recall

Bausch + Lomb announced that it has identified what led to a voluntary recall of its IOLs on the enVista platform in late March. With the cause and affected lots identified, the company is returning the enVista IOLs to the market. According to the company’s press release, the voluntary recall and subsequent investigation was launched in response to reports of toxic anterior segment syndrome (TASS) that appeared to be associated with some enVista lenses; the cause was identified as a “raw material used in certain lots that was delivered by a different vendor.” The company stated that it has implemented “enhanced inspection protocols for IOLs, as well as more explicit standards for how the monomers that make up its lenses are prepared by vendors.” Bausch + Lomb expects the enVista IOLs to return to full market supply in the coming weeks in the U.S.

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Laser endoscopy ophthalmic system receives FDA 510(k) clearance

BVI Medical announced FDA 510(k) clearance of its Leos (Laser Endoscopy Ophthalmic System) as an ECP laser for glaucoma. According to the company’s press release, this is the “only laser system that lowers intraocular pressure by addressing aqueous humor production in a minimally invasive ab interno procedure,” and it “incorporates unique endoscopic capabilities to provide superior visualization of the eye anatomy.” The company is planning for a commercial launch in the coming month.

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Study: Home OCT impacts physician decision making

A study published in the Journal of VitreoRetinal Diseases has definitively shown that home OCT is impacting physician decision making. Notal Vision, the maker of the ForseeHome system that monitors progression from dry AMD to wet AMD at home, noted that this is the first time a study has demonstrated changes in physician decision making based on home OCT data (prior studies showed feasibility). According to the company’s press release about the study, which was in a simulated environment, physicians made a different decision regarding treatment choice and timing in nearly every case. Forty-two percent of the time, physicians said they would not treat the patient, at this point, if they were seeing them in real life, which could be a potential $1 billion in savings to the healthcare system by avoiding earlier treatments. When physician readers said they would treat, the study found they would have brought the patients in earlier based on the data.

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FDA does not approve requested extended dosing interval for aflibercept injections

Regeneron Pharmaceuticals reported that the FDA issued a complete response letter regarding its supplemental Biologics License Application for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD (aflibercept), 8 mg, for all currently approved indications. It’s currently approved for every 8–16 weeks for wet AMD and DME and every 8–12 weeks for diabetic retinopathy, after an initial course of 3 monthly doses. The FDA did not agree with the additional extended dosing intervals, the company reported, but it also did not identify any safety or efficacy issues with EYELEA HD in its currently approved indications or dosing regimens. In a separate press release, Regeneron announced that the FDA had accepted with priority review its supplemental Biologics License Application for macular edema following retinal vein occlusion and broadening the dosing schedule to include every 4 week dosing across approved indications. The FDA’s target action date is August 19, 2025.

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First patient enrolled in Phase 3 trial investigating gel for moderate to severe dry eye disease

Zhaoke Ophthalmology Limited announced that it has enrolled its first patient in its Phase 3 clinical trial investigating its cyclosporine ophthalmic gel, 0.05%, for treatment of moderate to severe dry eye disease (DED), taking place at 25 centers and enrolling 360 patients. According to the company’s press release, the cyclosporine ophthalmic gel is a proprietary hydrogel with a “novel formulation [that] enhances the pharmacokinetic profiles and exposure of CsA on the ocular surface, giving CsA more time to exert its effect on DED.”

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is available onsite for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California.
• ASCRS Business of Refractive Cataract Surgery Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home resource library, will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Chicago, Illinois, on June 12.
• New ASCRS Cornea Clinical Committee Webinar: Antibody Drug Conjugates—An Emerging Class of Cancer Therapeutics Which Pose Risks to Corneal and Anterior Segment Health,” with moderators Naveen Rao, MD, and Winston Chamberlain, MD, along with speakers Kamran Riaz, MD, Stella Kim, MD, and Farooq Asim, MD, covers what antibody drug conjugates are, what they’re used for, complications and adverse reactions within the anterior segment associated with these drugs, and more.

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Research highlights

• A multicenter, non-inferiority, randomized clinical trial took place in seven ophthalmology centers in China, seeking to investigate whether phacogoniotomy is non-inferior compared to phacotrabeculectomy for patients with advanced primary angle-closure glaucoma and cataract. The primary outcome measure was reduction in IOP from baseline at the 2-year visit with a non-inferiority of 4 mm Hg, according to the paper published in JAMA Ophthalmology. The study randomized 124 patients (65 to the phacogoniotomy group and 59 to the phacotrabeculectomy group), and 59 in the phacogoniotomy group and 52 in the phacotrabeculectomy group completed the 2-year visits. The mean IOP reduction was –26.6 mm Hg and –24.7 mm Hg in the phacogoniotomy and phacotrabeculectomy groups, respectively. The authors concluded that phacogoniotomy was non-inferior to phacotrabeculectomy in these cases with no differences in complete or qualified success or mean number of IOP-lowering medications, supporting phacogoniotomy as an alternative to phacotrabeculectomy.
• Trends in toxic anterior segment syndrome (TASS) reported to the ASCRS TASS Task Force between 2012–2022 were analyzed and reported in a cross-sectional study published in the Journal of Cataract & Refractive Surgery. The paper included data from 77 questionnaires, comprising 56,319 cataract surgeries and 539 reported cases of TASS. The authors noted that common practices associated with TASS outbreaks were as follows: reuse of single-use cannulas, phacoemulsification and irrigation/aspiration tips (69%); use of enzymatic cleaners (40%); inadequate flushing of phacoemulsification and irrigation/aspiration handpieces (27%); reuse of phacoemulsification tubing (22%); use of preservative-containing intracameral anesthetic (18%); and antibiotics added to a balanced salt solution (17%). These trends, the authors wrote, can help find and identify safe alternatives to certain practices to prevent this complication.

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Product news

• Sight Sciences will debut the OMNI Edge Surgical system, an expansion of its OMNI product family, at the ASCRS Annual Meeting this weekend.

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