World’s first whole-eye transplant

NYU Langone Health announced that a surgical team performed the world’s first whole-eye transplant along with a partial-face transplant for a 46-year-old military veteran who endured a high-voltage electrical accident. According to the hospital’s news article, the procedure took place in May, and it’s unknown still whether the transplanted eye will ever allow functional sight, but it noted that the transplant “has shown remarkable signs of health, including direct blood flow to the retina.” When it became clear the patient’s eye needed to be removed, several months after the injury, the surgical team advised cutting the optic nerve as close to the eyeball to preserve nerve length for reconstructive options; at a later date the family and surgical team decided to pursue a whole-eye transplant for cosmetic reasons. In the news article, the surgeon leading the transplant team stated that a whole-eye transplant was long thought to not be possible, and this accomplishment is a “major step forward” that has “paved the way for the next chapter to restore vision.”

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Regenerative Medicine Advanced Therapy designation for investigational therapy for Leber congenital amaurosis

Atsena Therapeutics was granted a Regenerative Medicine Advanced Therapy designation for ATSN-101, an investigational treatment for Leber congenital amaurosis caused by biallelic mutations in the GUCY2D gene. These types of mutations account for 20% of Leber congenital amaurosis and currently have no approved treatment, according to the company’s press release. The company reported that this designation from the FDA, which expedites drug development and review, was based on 6-month efficacy data from the ongoing Phase 1/2 clinical trial. ATSN-101 already has an Orphan Drug Designation from the FDA.

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48-month trial data for retinal prosthesis for patients with severe atrophic AMD

Pixium Vision announced 48-month trial data that confirmed the previous 36-month results for the feasibility and tolerability of its subretinal prosthesis to improve some vision for patients with severe atrophic AMD with central vision loss. According to the company’s press release, the PRIMA photovoltaic retinal simulation microchip, in this first-in-human trial, was able to significantly improve participants’ ability to recognize letters and sequences of letters. The company also reported that there was no reduction in participants’ peripheral vision. A full data readout from this European open-label, baseline controlled, nonrandomized, multicenter, prospective single-arm pivotal trial, which enrolled 38 patients, will take place in the second quarter of 2024. The company described the retinal prosthesis as a self-sustaining microchip that is inserted under the fovea. It has 378 pixels, each of which convert light projected from augmented reality glasses worn by the user into an electrical current that stimulates inner retinal cells.

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First patient dosed in Phase 1/2 trial for Stargardt disease gene therapy

Ocugen announced that it has dosed its first patient in its Phase 1/2 trial evaluating a modified gene therapy for treatment of Stargardt disease. According to the company’s press release, OCU410ST is delivered subretinally and uses an AAV platform for the delivery of the RORA (RAR related orphan receptor A) gene. Ocugen’s modifier gene therapy approach is based on nuclear hormone receptor RORA, which regulates pathway links to Stargardt disease, the company reported.

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Partnership to develop molecule targeting DME

Clearside Biomedical announced its partnership with BioCryst Pharmaceuticals to develop the latter company’s plasma kallikrein inhibitor, avoralstat, with Clearside’s SCS Microinjector for patients with diabetic macular edema. BioCryst stated in its own press release that “elevated plasma kallikrein may be a cause of non-response to anti-VEGF therapy.” The company will present nonclinical data showing high levels of avoralstat delivered via suprachoroidal injection were maintained in the eye for at least 90 days.

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ASCRS news and events

• ASCRS Grand Rounds: The latest episode of ASCRS Grand Rounds, presented by residents and faculty at Tulane University School of Medicine, is posted. Watch it online.
• ASCRS Annual Meeting: There is an open call for submissions for case videos for four sessions at the 2024 ASCRS Annual Meeting. Click here to learn more about each of these opportunities and how to submit.
• A Taste of ASCRS: This nine-section CME program is available on demand. Learn more about the program.

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Research highlights

• A retrospective, nonrandomized, unmasked chart review published in the Journal of Cataract & Refractive Surgerysought to assess the efficacy of individualized LASIK based on ray tracing. The study included 400 eyes (200 patients) with less than 8.25 D of myopia and 0 to –4.25 D of astigmatism treated with ray trace-based LASIK. According to the paper, the ray trace-based algorithm created an individualized 3D model of the eye and calculated the customized ablation profile. At 3 months postop, UDVA was 20/20 or better in all eyes, 20/16 or better in 89% of eyes, 20/12 or better in 51% of eyes, and 20/10 in 8% of eyes. The authors reported that UDVA was within 1 line of the preoperative CDVA in 98% of eyes; 39% of eyes gained 1 line of improvement.
• A population-based, cross-sectional study assessed the risk of keratoconus associated with psychiatric comorbidities. The study, published in JAMA Ophthalmology, included 940,763 teens and adults (59.3% were male) with keratoconus in 1,533 (0.16%). The researchers found that patients with keratoconus were more likely to have an ADHD diagnosis, compared to the general population, even after adjusting for age, sex, intellectual status, height, and weight. The authors reported that stratification according to age showed an association between keratoconus and ADHD among males. These findings, they concluded, while not establishing a cause, could support future research regarding education about eye rubbing in this population. An invited commentary about this study suggested that education about eye rubbing in this population might not be enough: “Many of our patients with keratoconus are young, and badgering them or their parents to change their intrinsic response to itching is less appropriate than providing care for itching and accommodations for their intrinsic response to the itch,” the commentators wrote.

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Product news

• Bausch + Lomb received a CPT Category 1 code (67516) for XIPERE (triamcinolone acetonide injectable suspension) from the American Medical Association.

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