FDA 510(k) clearance granted to cataract surgery system

Oertli Instrumente announced that it received FDA 510(k) clearance for its Faros anterior cataract surgery system. According to the company’s press release, Faros has a small footprint and a quick setup time, along with precise fluid and vacuum control.

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Laser for POAG receives CE Mark

The ViaLase Laser, designed for treatment of primary open angle glaucoma, received the CE Mark in the European Union. According to the company’s press release, this laser uses femtosecond laser technology and micron-level image guidance to deliver a non-invasive “femtosecond laser, image-guided, high-precision trabeculotomy,” which is dubbed FLigHT. Commercial rollout is expected in the European market later this year.

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Collaboration to develop dry eye treatment

Eyenovia and SGN Nanopharma announced their agreement to collaborate on development of a treatment for chronic dry eye disease using SGN’s Micellar Nanoparticle Platform cyclosporine formulation with Eyenovia’s Optejet dispenser. Eyenovia also announced its agreement to collaborate with Senju Pharmaceutical to develop the latter’s corneal epithelial wound healing candidate (SJP-0035) for use with the Optejet dispenser for chronic dry eye.

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First patients enrolled in Phase 3 wet AMD trial

Ocular Therapeutix announced that it began enrolling its first patients in the Phase 3 clinical trial evaluating repeat dosing of AXPAXLI (axitinib intravitreal implant) for treatment of wet AMD. This non-inferiority study will enroll 825 patients to evaluate repeat dosing of the implant every 6 months compared to 2 mg of aflibercept dosed every 8 weeks. The company reported that a third arm will evaluate 8 mg of aflibercept dosed every 6 months to ensure adequate masking. The primary endpoint of the study is non-inferiority of mean best corrected visual acuity change from baseline between AXPAXLI and the on-label aflibercept (2 mg) after 1 year.

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New open-access textbook on lens power calculations

The IOL Power Club announced the availability of a new 72-chapter textbook, “Intraocular Lens Calculations,” published by Springer Nature and edited by Jaime Aramberri, MD, Kenneth Hoffer, MD, Thomas Olsen, MD, Giacomo Savini, MD, and H. John Shammas, MD. The textbook is open-access in a digital format or can be purchased as a hardcopy.

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ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery Summit: This new course will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients on their refractive surgery journey. Learn more.
• ASCRS Live! This educational dinner series is heading to nine cities across the U.S. Registration is open for events in Minneapolis, Minnesota, August 15 and Cleveland, Ohio, September 12.
• ASCRS Annual Meeting: The call for abstract submissions for the 2025 ASCRS Annual Meeting closes August 26. Submit your abstracts now.
• ASCRS Foundation: Residents, fellows, and surgeons within their first 5 years of practice with an interest in global eyecare are encouraged to apply for the Young Eye Surgeons International Service Grant. Learn more here.
• 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

• The long-term outcomes of congenital cataract surgery performed in the first 6 months of the patient’s life was evaluated in a retrospective chart review. The research, published in the Journal of Cataract & Refractive Surgery, included 216 eyes of 121 patients with a follow-up of 13.0±2.3 years. They found that surgical intervention at 10 weeks for bilateral cases and 6 weeks for unilateral cases resulted in significantly better final visual acuity compared to surgery after this timeframe. Secondary glaucoma was similar between the groups, but visual axis opacification occurred more frequently when surgery was earlier. Secondary glaucoma was significantly more prevalent in aphakic eyes compared to pseudophakic eyes. The authors concluded that “the use of IOL with sophisticated surgical techniques shows promise even in congenital cataract surgery.”
• Induced higher order wavefront aberrations after smooth incision lenticular keratomileusis (SILK) for myopic correction with and without astigmatism with the ELITA Femtosecond Platform (Johnson & Johnson Vision) was evaluated in research published in Clinical Ophthalmology. The study included 24 eyes that had the SILK procedure. Manifest refractive spherical equivalent preop ranged from −6.00 to −2.25 D and 9 months postop ranged from −0.50 D to 0.00 D. Compared to baseline, HOAs significantly increased 1 day after surgery and remained out to 9 months of follow-up. The authors reported no significant difference in mean HOAs at 1 week postop for horizontal coma and spherical aberration. They concluded that HOAs induced were minimal and that the procedure resulted in fast corneal recovery without inducing spherical aberration.

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Product news

• OCuSOFT Retaine Allergy (olopatadine hydrochloride ophthalmic solution, USP 0.2%) is now available via prescription from eyecare providers.

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