Company to begin trial with dual-optic accommodative lens

Atia Vision received approval from the FDA to begin a feasibility clinical study with its OmniVu Lens System. According to the company, this dual-optic lens is designed to offer a more natural, accommodative range of vision. The lens consists of a fluid-filled, shape-changing base for focusing power and a front optic that gives the patient their needed optical power. The company also reported that the lens has a more physiologic shape to fill the capsular bag, which could help “preserve the eye’s anatomic integrity and elasticity.” The lens has already been studied in humans outside the U.S. with more than 75 lenses implanted and up to 3 years of follow up. From these cases, the company reported that 100% of patients achieve 20/20 or better UDVA, with preliminary contrast sensitivity and patient-reported vision quality outcomes showing the lens to be on par with monofocal lenses.

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Phase 2 study to begin for immunoglobulin drops for dry eye

The FDA approved Grifols’ Investigational New Drug application to begin a Phase 2 trial evaluating GRF312 Ophthalmic Solution, which the company’s press release stated “could become the first-ever ocular surface indication for an IG [immunoglobulin] and a potential new treatment for dry eye disease.” According to the company, the study will enroll 100 patients with dry eye and is expected to begin in the third quarter of this year to assess safety, tolerability, and efficacy. The Phase 2 trial builds upon the Phase 1/2 trial, which found that patients who took the IG drops twice daily achieved a significant reduction in dry eye disease signs and symptoms with no difference in tolerability or adverse side effects compared to patients who received placebo. Grifols is collaborating with Selagine, a clinical-stage, spin-out company of the University of Illinois that is commercializing technology developed within the College of Medicine’s Department of Ophthalmology & Visual Sciences. In the licensing agreement, Grifols has worldwide exclusive rights to Selagine’s treatment.

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Long-term durability of TED treatment demonstrated

Viridian Therapeutics announced positive long-term durability data from its Phase 2 clinical trial of veligrotug for patients with active thyroid eye disease. Veligrotug, an IV-delivered anti-insulin-like growth factor-1 receptor antibody, or placebo was given to patients in 5 infusions every 3 weeks with topline results collected at 15 weeks and longer-term follow-up at 52 weeks. At 52 weeks, 70% of patients who received veligrotug and were 15-week proptosis responders were found to maintain their proptosis response for the rest of the year (they still had at least 2 mm reduction in proptosis compared to baseline without worsening in their fellow eye). Over 52 weeks, there were no changes in the drug’s safety profile, and most adverse events reported at 15 weeks had resolved by week 52. According to the press release, the company is planning to submit a Biologics License Application later this year and estimates a potential launch in 2026.

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Positive Phase 1/2 data from study evaluating X-linked retinoschisis

Atsena Therapeutics announced positive results from part A of its Phase 1/2 clinical trial evaluating subretinal injection of ATSN-201 for treatment of X-linked retinoschisis. According to the company’s press release, this part of the study was to evaluate safety and tolerability of three different doses of ATSN-201 among 9 total patients, 3 in each cohort. There were no serious adverse treatment-related events. Most adverse events, according to the company, were related to the surgical procedure. No dose-limiting toxicities were observed, and no participants discontinued the study. Efficacy was observed at all dose levels, with 7 of 9 treated eyes having closure of foveal schisis. Statistically significant improvements in BCVA and low luminance visual acuity were also observed. Part B of the study, which will enroll 9 additional adults and 3 pediatric patients, is underway.

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Eye drop recall

AvKARE announced a voluntary recall of some of its drops due to “manufacturing cGMP deviations,” which were identified during an FDA audit. The company stated in a press release that the “health hazard to the user is unknown,” but clarified that “cGMP deviations may lead to products of unacceptable quality.” The full list of recalled products can be found here and the FDA’s Enforcement Report can be found here.

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ASCRS news and events

• 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.
• ASCRS Grand Rounds: A new episode of ASCRS Grand Rounds, featuring cases involving a challenging intraoperative cataract surgery complication and a referral for a corneal mass, is online now. Watch the episode, which is eligible for CME, here.
• 2026 ASCRS Annual Meeting: Hotel room blocks are now open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026.

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Research highlights

• Secondary analysis of a randomized clinical trial sought to evaluate whether capsular tension rings influence target refraction and refraction prediction accuracy in the setting of high myopia. The study included 186 highly myopic eyes that were randomized into a CTR group with a C-loop IOL (n=93) or a control group that only received a C-loop IOL (n=93); 161 patients were included in the analysis. The authors found that CTR implantation in highly myopic eyes did not affect target refraction and improved prediction accuracy of newer IOL calculation formulas in eyes with an axial length of 30 mm or more. “These findings support use of CTR implantation in eyes with an AL of 30 mm or longer,” they concluded. The study is published in JAMA Ophthalmology.
• A systematic review and meta-analysis published in the Journal of Cataract & Refractive Surgery sought to determine whether there were benefits of adding topical antibiotics to preoperative povidone-iodine (PVI) vs. PVI alone. The benefit specifically was characterized as a reduction of conjunctival bacterial flora that could reduce the risk of postop endophthalmitis. The research involved several database searches, including literature up to October 2024. Seven studies comprising 1,423 eyes were included, with no significant difference in the reduction of conjunctival bacterial flora between PVI alone and PVI with antibiotics. Subgroup analysis, according to the authors, found that levofloxacin with PVI significantly reduced positive culture rates (no benefits were seen with moxifloxacin or gatifloxacin). With this, the authors concluded that there was “no conclusive benefit of using preoperative topical antibiotics alongside PVI in routine ophthalmic procedures. However, in patients at high-risk of endophthalmitis, levofloxacin may offer additional protection.”

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Product news

• Intalight received the CE mark for its DREAM OCT, a swept-source OCT platform. The company is working toward FDA clearance.

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