First patient treated with novel crosslinking approach for refractive error

TECLens announced that the first patient was treated with its CXLens for correction of refractive error as part of its first-in-human clinical trial. According to the company’s press release, this lens uses “quantitative corneal crosslinking (qCXL) technology for non-invasive refractive vision correction.” The company described the CXLens as using “patterned ultraviolet light to reshape the cornea while preserving the epithelium” in a manner that is personalized for individual patient needs. The current clinical trial is focused on patients with refractive error, including presbyopia. Use of the CXLens occurs in-office, and according to the press release, it does not require use of a speculum or removal of the epithelium, making the procedure more comfortable for the patient. The treatment includes “real-time biomechanical monitoring [to track] the cornea’s response throughout the procedure, automatically concluding when the desired correction is achieved.”

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Multisociety working group established to set guidelines for modern IOL classification

ASCRS, ESCRS, APACRS, and LATAMSCRS established the Functional Vision Working Group in 2025 at the Congress of the ESCRS to “set a global standard for evidence-based knowledge generation in IOL research and clinical practice,” according to a guest editorial from Fernández et al. published in the latest issue of the Journal of Cataract & Refractive Surgery. According to the editorial from Fernández et al., the working group will establish guidelines that will “evaluate the body of evidence supporting the classification of a given IOL, including a system to grade the level of certainty, defined as the degree of confidence that an IOL will deliver a given functional performance based on the Functional Classification.” The authors of the editorial wrote that this working group would emphasize patient-centered outcomes, which they said “complements regulatory classifications and enriches shared decision-making.” Read the full editorial for more about the Functional Vision Working Group.

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FDA reduces clinical trial requirement for new drugs to one pivotal trial

According to an announcement published in the New England Journal of Medicine authored by Vinay Prasad MD, MPH, FDA Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, and Martin Makary, MD, MPH, FDA Commissioner, the FDA will now make one pivotal trial the default option for approval of new drugs. Prior to this, two pivotal trials were needed. The agency representatives wrote that this new default does not mean that the FDA will never require two studies; it reserves that right for some situations. Dr. Prasad and Dr. Makary described in the announcement several reasons as to why the FDA is making “one adequate and well-controlled study, combined with confirmatory evidence,” the basis for marketing authorization. They wrote that they expect “a surge in drug development in response” to this initiative.

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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 Preview Program for more 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 short- and long-term visual and refractive outcomes of flanged intrascleral haptic fixation (FIHF) was compared to 2-point transscleral polymethyl methacrylate (PMMA) IOL fixation using Gore-Tex sutures for patients who lacked capsular support for in-the-bag placement. The retrospective cohort study included 82 total eyes (46 that received FIHF and 36 sutured fixation). After matching to minimize baseline differences, 34 eyes were included in each group for analysis. The FIHF group, according to the authors, showed significantly better CDVA at 1 month compared to the sutured group, with a mean logMAR of 0.73 in the FIHF group compared to 1.08 in the sutured group. A significantly better CDVA was also demonstrated in the FIHF group at 3 months (mean logMAR 0.62 vs. 0.94). The FIHF group had a significantly lower cylindrical power at 3 months compared to the sutured group, 1.94 vs. 3.69, respectively. There were no significant differences in CDVA, complication rates, or refractive outcomes between the two groups at 12 months postop. The authors concluded that FIHF can result in an earlier reduction of astigmatism and thus faster visual recovery compared to sutured IOL fixation, though no significant differences were observed after 12 months. The research is published in the Journal of Cataract & Refractive Surgery.
• A retrospective analysis published in the journal Ophthalmology and Therapy analyzed whether a triple-layer dehydrated, decellularized amniotic basement membrane tissue using a glueless, sutureless technique with short mitomycin-C exposure could reduce complications and recurrence of pterygium. According to the paper’s single author, Marguerite McDonald, MD, there is variation in recurrence rates depending on the patient population, follow-up duration, surgical technique used, and definition of what constitutes a recurrence in general. The retrospective review included 34 eyes from 33 patients who had pterygium excision with the dehydrated, decellularized basement membrane and the above-described technique. There was a 0% recurrence rate over a mean follow-up of 394 days. There were also “no pyogenic granuloma, infections, dellen, or melts,” according to Dr. McDonald. She concluded that compared to traditional amniotic membrane therapy and conjunctival autograft methods for pterygium using glue or sutures, the glueless, sutureless approach described in this paper “not only reduces operative time, postoperative discomfort, postoperative visits, and topical steroids but also saves costs without compromising outcomes.”

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Product news

• ZEISS Medical Technology launched ZEISS Collaborative Care, a browser-based software application that allows eyecare professionals to securely share data and patient referrals, addressing “longstanding challenges in ophthalmic care, particularly fragmented data sharing, and inefficient referral processes.”
• Lupin received CE marketing authorization for Ranluspec, with marketing to be performed by its partner Sandoz, as a biosimilar to Lucentis (ranibizumab, Genentech) for treatment of wet AMD, diabetic macular edema, proliferative diabetic retinopathy, macular edema secondary to retinal vein occlusion, and choroidal neovascularization.
• Harrow launched a direct-to-prescriber cash-pay offering, PharmaPack, as a way of “offering affordable FDA-approved branded products as alternatives to off-label compounded formulations.” There are two PharmaPacks available: one includes Maxitrol (neomycin and polymyxin B sulfates and dexamethasone) and Nevanac (nepafenac) and the other Tobradex ST (tobramycin and dexamethasone) and Nevanac. The kits will initially be available in California, Mississippi, Arkansas, Connecticut, and Alabama, but nationwide availability will come in the following weeks, according to Harrow.

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