FDA approves new EDOF with limited dysphotopsias

Johnson & Johnson announced FDA approval of its TECNIS PureSee IOL, which it described as an EDOF IOL that “delivers clarity of vision for patients, with 97% of them reporting no very bothersome visual disturbances.” The company also reported that the PureSee IOL is the “first and only U.S. FDA-approved extended depth of focus IOL with no warning on loss of contrast sensitivity.” According to the company’s press release, the lens will be available in the U.S. later this year; this IOL already has approval and commercial availability outside the U.S.

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Phase 1/2 12-month data for IOL-based drug delivery system

SpyGlass Pharma announced 12-month data from its Phase 1/2 trial evaluating the Bimatoprost Drug Pad-IOL System (BIM-IOL System) for treatment of IOP in patients with open-angle glaucoma or ocular hypertension. The IOL-based drug delivery system was placed as part of cataract surgery. The study enrolled 104 patients who were randomized 2:1:1 to receive 78 mcg BIM-IOL System (N=51) plus daily artificial tears, 39 mcg BIM-IOL System (N=23) with daily artificial tears, or a standard monofocal IOL with twice daily timolol drops, serving as the control group (N=30). At 12 months among evaluable patients, the 78-mcg and 39-mcg groups saw a 34% and 42% reduction in IOP, respectively, compared to 35% IOP reduction in the control group. Most patients who received the BIM-IOL system (98% in the 78-mcg group and 96% in the 39-mcg group) were free from topical IOP-lowering drops at 12 months. In terms of vision, among all evaluable patients, 100% reached 20/32 or better BCDVA and achieved a mean BCDVA of 86 letters. Among the three groups, adverse event rates were similar, and no serious adverse events occurred. The company is currently performing two Phase 3 registrational trials with the 78-mcg dose.

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Topline results from Phase 2a wet AMD study

NovaBridge Biosciences announced positive topline results from its Phase 2a study evaluating VIS-101 for treatment of wet AMD. VIS-101 is described as a dual VEGF-A X ANG-2 inhibitor; it is in development for wet AMD, diabetic macular edema, and retinal vein occlusion. The topline results of the therapy for wet AMD showed, overall, “rapid, robust and durable treatment responses.” Two dose cohorts were evaluated (3 mg, N=25 and 6 mg, N=13). The mean improvement in BCVA was more than 10 ETDRS letters, and median central subfield thickness was reduced 100–150 mm. Overall, there was a favorable safety profile with no dose limited toxicity observed. About two-thirds of patients were retreatment-free at 4 months, and half were retreatment-free at 6 months. In a press release, company leadership stated that these results support advancement of VIS-101’s clinical program, with a dose-limiting Phase 2b study planned for later this year and a Phase 3 program in 2027.

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FDA grants Breakthrough Device Designation to brain implant technology

ReVision Implant received a Breakthrough Device Designation from the FDA for its Occular system, which consists of a microelectrode array brain implant, an exterior camera/eyeglass system, and algorithm technology to transmit information from a camera-based video stream to the electrodes to stimulate the visual field in vision-impaired individuals. The technology, according to the company’s website, interfaces with the brain’s visual cortex with the hope of enabling “blind people to regain useful vision.” Preclinical studies with the technology showed activation in the “visual cortex regions in response to patterned stimulation,” evidence that “stimulation patterns can be differentiated and interpreted by subjects,” and scalability that the technology could yield similar results seen in small animal models in primates.

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FDA allows Phase 1/2 trial to begin for investigational cell therapy for familial drusen

Sanaregen Vision Therapeutics announced that the FDA has approved its Phase 1/2 trial to move forward in its evaluation of SVT-001 as an investigational cell therapy for restoration of retinal function and vision for patients with familial drusen, a form of macular degeneration. The company thinks that SVT-001 could also be a therapeutic candidate in the future for AMD.

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ASCRS news and events

• 2026 ASCRS Annual Meeting: Register now for the 2026 ASCRS Annual Meeting in Washington, D.C., April 10–13. View the Real-Time Program for the most up-to-date program information.
• SightLine at ASCRS: Connect, collaborate, and confront the challenges shaping the commercial landscape of ophthalmology at this meeting taking place Thursday, April 9 ahead of the ASCRS Annual Meeting. This meeting is for all commercial stakeholders in ophthalmology to learn about 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 9 ahead of the ASCRS Annual Meeting and ASOA Annual Meeting. Learn more.

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Research highlights

• The 3-year visual and subjective outcomes of two different mix-and-match IOL combinations were evaluated in a single-center, prospective clinical trial published in the Journal of Cataract & Refractive Surgery. The study enrolled 50 patients who received the Isopure IOL (BVI Medical), an enhanced monofocal, in their dominant eye and either the Finevision HP (BVI Medical) trifocal or the Finevision Triumf IOL (BVI Medical), an extended depth of focus IOL, in their non-dominant eye. Sixty-eight eyes from 34 patients were available for 3-year follow-up. The authors found that the enhanced monofocal with either the trifocal or EDOF in the opposite eye resulted in “excellent distance and intermediate vision.” Near vision and spectacle independence were higher in the enhanced monofocal-trifocal group, and postop dysphotopsias, such as glare and halo, were comparable regardless of whether the patient received a trifocal or EDOF in the non-dominant eye. The authors concluded that both mix-and-match strategies resulted in “low incidence of photic phenomena and high patient satisfaction” over the long term.
• The safety of an intracanalicular dexamethasone ophthalmic insert and topical ketorolac, 0.5%, vs. ketorolac and prednisolone acetate, 1%, in postop month 1 of cataract surgery was evaluated in a retrospective, single center study. The cataract surgeries included were uncomplicated and occurred between June 2020 and March 2023. There were 100 eyes (78 patients) in the intracanalicular insert/ketorolac group and 102 eyes (83 patients) in the control topical ketorolac/prednisolone group. There were no differences in the rate of postop rebound inflammation between the two groups or in rate of development of cystoid macular edema. There were no cases in either group of an IOP increase of more than 10 mm Hg, in the first month postop. With these findings, the authors concluded that the intracanalicular insert was a “safe and effective dropless alternative” to the topical ketorolac/prednisolone therapy after cataract surgery. The research is published in the journal Clinical Ophthalmology.

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Product news

• The Cassini Guidance System (Cassini Technologies) received Medical Device Regulation (MDR) approval in the E.U. for intraoperative IOL alignment.

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