FDA grants De Novo classification to ocular pressure adjusting pump

Balance Ophthalmics announced that the FDA has granted De Novo classification to its FYSX Ocular Pressure Adjusting Pump. This device for IOP management in normal tension and open angle glaucoma is described by the company as the first non-pharmacological, non-surgical treatment for IOP lowering. According to the company’s press release, FYSX is a prescription-only device indicated to reduce IOP during sleep for adults with open angle glaucoma and IOP of 21 mm Hg or more who are using or have previously had another IOP-lowering treatment. The company’s press release stated that commercialization and market access for FYSX is expected in late 2025.

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Inaugural ‘State of Dry Eye’ survey

Bausch + Lomb announced findings from its inaugural “State of Dry Eye” survey. Among its key findings are that: 75% of people with dry eye find the condition extremely or very bothersome; 81% of those with dry eye are “constantly aware of how their eyes feel”; and 67% of participants with dry eye have given up or cut back on activities to relieve dry eye symptoms. The survey also identified a lack of awareness about dry eye, with 70% not knowing how to prevent or treat it; many don’t realize the symptoms they could be experiencing are often associated with dry eye. Forty-four percent of respondents didn’t know that dry eye, if left untreated, could lead to other eye problems. This survey was conducted April 15–23, 2024, and included 2,003 adults aged 18 and older, 416 of whom reported “often/always” experiencing eye dryness or being diagnosed with dry eye disease by a healthcare professional.

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Study: potentially higher risk for blinding ocular condition with semaglutide use

A study published in JAMA Ophthalmology last week suggested “an association between semaglutide and NAION [nonarteritic anterior ischemic optic neuropathy].” The American Academy of Ophthalmology and the North American Neuro-Ophthalmology Society issued a press release regarding the study noting, among other things, that “this is not the type of study that can show the treatment caused NAION” though there is a “potential link” that should “inspire more research,” which the study authors also called for. The two societies also noted that there are other risk factors for NAION that can be taken into account with this study as well.

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Wet AMD treatment implant reintroduced

Genentech announced that it was reintroducing Susvimo, a 100 mg/mL ranibizumab injection administered via ocular implant with the ability to be refilled twice per year, following a voluntary recall. According to the company’s press release, the FDA approved the company’s post-approval supplement to its Biologics License Application. This supplement included “component-level updates made to the ocular implant and refill needle.” The company stated that Susvimo will be available in the U.S. within weeks.

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Acquisition news

Alcon completed its acquisition of Belkin Vision, expanding its glaucoma portfolio with Belkin’s first-line direct selective laser trabeculoplasty (DSLT) technology.

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ASCRS news and events

• Ophthalmology Quicksand Chronicles—Eureka Moments! This ASCRS podcast with hosts Nicole Fram, MD, and Elizabeth Yeu, MD, is back for its fourth season. Watch the first episode with guest Sumit “Sam” Garg, MD.
• 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! The next stop for the ASCRS Live! dinner series, which is bringing education and networking events to several U.S. cities in 2024, is Washington, D.C., July 18. Register now.
• ASCRS Annual Meeting: The call for abstract submissions is now open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025.
• 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

• Gender differences in biometric parameters in a large sample size of cataract patients was the topic of a retrospective, single-center, observational study published in the Journal of Cataract & Refractive Surgery. The biometric data, obtained via the IOLMaster 700 (Carl Zeiss Meditec) and Pentacam HR (Oculus), from 34,589 eyes of 20,000 patients with cataracts revealed that there were significant differences in most variables between the sexes. This included shorter eyes and shorter aqueous depth in females, as well as steeper anterior keratometries among females. There was not a difference in anterior astigmatism magnitude observed but a difference in orientation. According to the authors, “the distribution of IOL power differed between the sexes with the interquartile range shifting 1 D toward more powerful lenses in women.” The authors stated that this large sample revealed “highly significant differences between sexes in ocular biometry,” which “supports the idea that including sex as a parameter in IOL calculation should be explored and may improve results.”
• A randomized placebo-controlled, double-masked clinical trial published in JAMA Ophthalmology evaluated the efficacy and safety of 0.01% atropine drops on myopia progression, exotropia conditions, and binocular vision in patients age 6–12 with myopia and basic intermittent exotropia (IXT). Prior to this study, according to the authors, there was limited evidence regarding atropine for myopia control in patients who also had IXT. Participants were randomized 2:1 to receive 0.01% atropine (n=200) or placebo (n=100) once nightly for 12 months. The findings showed the atropine group had slower spherical equivalent progression and axial elongation compared to placebo. The authors also reported a “decrease in near magnitude of exodeviation” in the atropine group, while the placebo group had an increase. The authors concluded that atropine, while it did compromise accommodative amplitude to an extent, “slowed myopia progression without interfering with exotropia conditions or binocular vision” in this patient population.

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