Study evaluates safety of office-based lens surgery

iOR Partners, a company that helps create in-office surgical suites, announced that a study evaluating the safety of lens surgery in an office-based OR was published in the Journal of Cataract & Refractive Surgery. The study included 36 private practices in the U.S. and analyzed 18,005 consecutive cases of patients who had cataract surgery, refractive lens exchange, or phakic IOL implantation from August 2020–May 2022. According to the paper, rates of endophthalmitis, TASS, and corneal edema were 0.028%, 0.022%, and 0.027%, respectively. Unplanned anterior vitrectomy was needed in 0.177% of cases, 0.067% had to return to the OR for some reasons, and 0.011% had to be referred to a hospital. The authors concluded that these procedures in the office-based setting had similar or lower adverse event rates than cataract surgery in a more traditional setting.

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FDA issues response to BLA for 8 mg aflibercept

Regeneron Pharmaceuticals received a complete response letter from the FDA for its BLA for aflibercept 8 mg. The company reported that this letter was “solely due to an ongoing review of inspection findings at a third-party filler” and that there were not issues mentioned in the letter with clinical efficacy, safety, trial design, labeling, or manufacturing. Regeneron also noted that the FDA did not request additional clinical data or trials. Regeneron submitted a BLA for aflibercept 8 mg for treatment of wet AMD, DME, and diabetic retinopathy. This week the company also released 2-year topline results for aflibercept 8 mg in patients with DME. The trial found that 89% of patients maintained a 12 or more week dosing interval through 2 years; 83% of those assigned to the 16-week dosing regimen were able to maintain this interval or greater through 2 years. Visual gains and safety with this higher dose of aflibercept were similar to the lower dose (EYLEA, aflibercept 2 mg injection, Regeneron Pharmaceuticals).

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Pre-clinical data for non-viral gene therapy

Intergalactic Therapeutics announced positive preclinical data from its non-viral gene therapy platform for treating ABCA4-related retinopathies. The company reported that a single subretinal injection in non-human primates of IG-002 achieved durable 6-month expression of the ABCA4 gene in these primate retinas. The vector platform for this gene therapy is called C³DNA—covalently closed and circular DNA. Twelve-month durability of IG-002 was previously demonstrated in porcine retinas. A Phase 1 trial is expected to begin in 2024.

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Non-human primate study of dry AMD therapy

Visgenx announced positive data from its study on non-human primates with its VGX-0111 treatment for dry AMD. VGX-0111, according to the company’s press release, carries the ELOVL2 transgene, which encodes for an enzyme that plays a role in the synthesis of long chain and very long chain polyunsaturated fatty acids that are thought to play a role in dry AMD pathogenesis. The company reported that it’s known that the ELOVL2 gene declines with age, leading to a reduction in these essential fatty acids. The company plans to move forward with developing a human proof-of-concept study.

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Expanded insurance coverage for MIGS procedures

Sight Sciences announced that Cigna updated its Glaucoma Surgical Procedure policy to cover ab interno canaloplasty and goniotomy (trabeculotomy) procedures for patients with open angle glaucoma. This policy went into effect June 15.

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ASCRS news and events

• ASCRS Summer Meeting: Save your seat at the ASCRS Summer Meeting in Nashville, Tennessee, August 11–13. Reserve your hotel room by July 14 to receive the discounted meeting rate.

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Research highlights

• A study published in the Journal of Cataract & Refractive Surgery evaluated the levels of vitamin B12, folic acid, riboflavin, and homocysteine in blood, comparing keratoconus (n=100) and healthy (n=200) participants between 18–35 years old. Homocysteine, vitamin B12, and folic acid levels were similar between the two groups. However, there was a significant difference in mean riboflavin level in the group with keratoconus compared to control, with 99% of keratoconus patients having levels below 180 μg/L compared to 53% below this level in the control group. The authors concluded that low levels of riboflavin might be a risk factor in the pathogenesis of keratoconus.
• A survey of patients in the U.K. evaluated their understanding of premium IOLs (toric, EDOF, multifocal). According to the findings published in the journal Eye, a 12-question survey was taken by 360 participants, 66.5% of whom had not yet had cataract surgery. The majority of survey respondents wore glasses in some capacity, and most (85.8%) didn’t mind wearing glasses after cataract surgery. The survey found that 75.3% of patients were not familiar with premium IOL options, and 58.9% said they were not willing to consider them when they were told of a 2% risk of debilitating dysphotopsia.

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Product news

• Bruder Healthcare has partnered with AllerFocus to distribute its Percutaneous Allergy Test, which is a needle-free screening of 78 airborne and environmental allergens that can result in an allergic eye response.

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