FDA 510(k) clearance granted to non-invasive glaucoma treatment

The FDA granted 510(k) clearance to Balance Ophthalmics’ wireless, next-generation FSYX Ocular Pressure Adjusting Pump, building upon its prior de-novo classified platform as the “first device designed specifically for nocturnal intraocular pressure (IOP) reduction,” according to the company’s press release. The new wireless design allows physicians to obtain real-world patient data from this at-home therapy, which is considered “the first and only non-pharmacological, non-surgical treatment designed to lower IOP during sleep in patients with glaucoma,” according to the company. The system, which includes a pump and pressure-modulating goggles, is available with a prescription (availability expected in the fourth quarter of 2026). The company noted that in 12 studies of more than 600 eyes, the FSYX (pronounced “physics”) device showed a mean 39% IOP reduction in nocturnal IOP with no device-related serious adverse events. It is designed to be used with other glaucoma therapies.

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Study: GA treatment increases probability of driving capabilities among patients

A pooled post-hoc analysis of two Phase 3 clinical trials found that use of IZERVAY (avacincaptad pegol intravitreal solution, Astellas) compared to sham reduced the risk of progression of geographic atrophy (GA), maintaining the functional skill of driving eligibility. The post-hoc findings from the studies, which followed patients over 24 months, showed that the loss of driving eligibility was 12.6% in patients taking IZERVAY monthly or every other month compared to 20.1% in the sham group. Looking at data from the IZERVAY every month group, driving eligibility loss was 15.1% at 24 months compared to 20.1% in the sham group.

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Third implantation of wireless visual prosthesis in the brain

A multi-institution team that developed a visual prosthesis for implantation in the brain has completed its third procedure in a study of the Intracortical Visual Prosthesis. This wireless brain implant, according to the Illinois Institute of Technology press release, bypasses the retina and optic nerves, connecting directly to the visual cortex to provide artificial vision. According to the press release, this is the first intracortical visual implant to use 34 permanent, fully implanted miniature wireless simulators and 554 electrodes in an individual who is completely blind. The technology is currently in a clinical phase to develop and refine surgical procedures and test the prosthesis and its ability to help patients learn to navigate and perform basic visual tasks. The research moving forward is seeking more adult volunteers who had normal to near normal vision for at least the first 10 years of their life but later lost vision.

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First-in-human results for geographic atrophy therapy

PulseSight Therapeutics announced presentation of its Phase 1 results evaluating PST-611 in patients with geographic atrophy. The company’s press release described PST-611 as a first-in-class gene therapy candidate that encodes transferrin, an iron transporter important for maintaining iron homeostasis; dysregulation of such homeostasis can lead to conditions like geographic atrophy. The Phase 1 trial was a single ascending dose first-in-human trial evaluating safety and tolerability of a high and low dose level. Both doses were deemed safe and tolerable, with most reported ocular adverse events being mild (two events were moderate). BCVA was stable during the follow-up period, and while the study was not designed to assess efficacy per se, the company reported “encouraging signals of early efficacy.” The company is planning a repeat dose Phase 2a trial to assess safety and efficacy of three administrations of the high dose over 52 weeks.

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SPA agreement with the FDA for optic neuritis trial

Oculis announced that it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its first registrational trial for Privosegtor for treatment of optic neuritis. This agreement, according to the company’s press release, confirms the study’s design and analysis would support a future NDA submission. The company described Privosegtor as a peptoid small molecule that can cross the blood-brain barrier and retinal barriers, giving it the potential to be the first neuroprotective therapy for optic neuritis.

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Company news

• NeuroVision Imaging acquired Durin Life Sciences to create an integrated neurodegenerative disease diagnostics and care platform that combines retinal imaging technology, telehealth infrastructure, and a patient engagement platform.

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ASCRS news and events

• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2026. Registration is open for the next event in Omaha, Nebraska, on June 11.
• ASCRS Online Education: The ASCRS CME Education Catalog offers a wealth of both CME and non-CME content for ASCRS members. Check out what your colleagues have been watching lately.
• ASCRS Annual Meeting: Hotel rooms are now available for the 2027 ASCRS Annual Meeting. Book your 2027 hotel in San Diego early to get your preferred room and location.

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EyeWorld article of the week

The Spring issue of EyeWorld features an article that looks at the viability and rise in oral sedation practices for cataract surgery. Proponents cite it as being efficient, cost-effective, and, at times, safer than traditional IV sedation. Read “Will oral sedation become mainstream?”

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Research highlights

• The efficacy and usability of a conversational AI chatbot for cataract surgery education was compared to the use of standard patient education brochures in a prospective, single-center, randomized controlled trial published in the Journal of Cataract & Refractive Surgery. The brochure group (n=31) served as the control, while the custom-built hospital-specific chatbot called “Mina” was the test group (n=33). Postoperative questionnaires were completed by 14 patients and 21 patients in the chatbot and brochure groups, respectively. There were no significant differences between the two groups in knowledge gain, anxiety changes, or patient satisfaction. In both groups, patient knowledge increased. Notably, 17 of the 33 participants in the chatbot group did not engage with the chatbot at all; those who did engage with it were younger. With these findings, the authors concluded that “chatbot engagement barriers, particularly among older adults, and limits of validated-only content indicate the need for a hybrid approach of those models, to balance safety and flexibility in digital patient education.”
• A multicenter, propensity-matched study published in the journal Nature suggests that neovascular glaucoma could be a marker of underlying systemic vascular issues that could lead to heart attacks and/or strokes. Data from patients with neovascular glaucoma within a global EHR network were compared with controls (demographics, comorbidities, medications, and healthcare use were accounted for) and followed for up to 10 years. A diagnosis of neovascular glaucoma was associated with a higher risk of “all-cause mortality (HR 1.70, 95% CI 1.60–1.81), myocardial infarction (HR 1.53, 95% CI 1.40–1.67), cardiac arrest (HR 1.57, 95% CI 1.36–1.82), stroke (HR 1.62, 95% CI 1.48–1.79), and [three-point major adverse cardiovascular events] (HR 1.59, 95% CI 1.51–1.68).” This increased risk for long-term mortality and cardiovascular events among patients with neovascular glaucoma, the authors wrote, could help identify patients who might have systemic vascular risk and need proactive care.

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