FDA approves treatment for subfoveal choroidal neovascularization due to AMD

Bausch + Lomb and Modulight reported FDA approval of its ML6710i photodynamic laser and VISUDYNE (verteporfin for injection) as a photodynamic therapy for treatment of classic subfoveal choroidal neovascularization due to AMD. According to the companies’ press release, the system is expected to be available to eyecare professionals within the first half of this year. The press release described the system as addressing a “significant unmet need in [photodynamic therapy]” for this indication.” More specifically, the press release described how the laser, which can be fit onto slit lamps, creates a circular, uniform spot for delivery of the VISUDYNE injection. VISUDYNE is a photosensitizer drug indicated for treatment of predominantly classic subfoveal choroidal neovascularization due to AMD, pathologic myopia, or presumed ocular histoplasmosis, according to the press release. It is activated through use of a photodynamic laser, allowing for a targeted treatment of abnormal choroidal blood vessels.

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IND for inherited RPE clinical trial receives FDA clearance

HuidaGene Therapeutics announced that the FDA approved its IND application to begin a clinical trial to study the one-time injection of a gene therapy intended to treat patients with RPE65 mutations that have led to retinal dystrophies. According to the company’s press release, this approval allows the company to begin a multinational, multicenter, multiple cohort, dose-finding study in adult and pediatric participants with retinopathies caused by mutations in this gene. The treatment being investigated, HG004, is a one-time, non-AAV2 gene replacement therapy. In preclinical data using a mouse model, HG004, compared to AAV2 at the same dose, showed a 67.6% increase in recovery of retinal function compared to 35.8% with the AAV2 product at week 17, according to the press release. The company thinks this shows that HG004 “demonstrates better transduction efficiency of the retinal pigment epithelium … and has the potential to lower total vector doses.” The in-human clinical study will evaluate safety, tolerability, efficacy, and long-term clinical durability after a single injection of HG004 for up to 52 weeks. Visual function will also be assessed.

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Phase 3 clinical trial to evaluate cooling device for anesthesia prior to injections

RecensMedical, which is developing a cooling technology to serve as anesthesia prior to intravitreal injections, partnered with Vial for its Phase 3 clinical trial of the system. According to the company’s press release, the Phase 3 clinical trial for the Ocu-Cool system is taking place in South Korea and, if approved, it would be the “first ever medical device from South Korea to receive de novo clearance from the FDA.”

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Study calls ‘long-believed theory about diabetic cataracts into question’

Research from Brigham and Women’s Hospital is calling the “long-believed theory about diabetic cataracts into question,” according to a press release about the study. The research, published in the Journal of Biomedical Science, contradicts the widely held “sugar hypothesis,” which is that high blood sugar causes structural changes in the lens that leads to diabetic cataract development. The more current research found that “immune cells were migrating from …the ciliary bodies toward the lens,” and “epithelial cells that normally cover the inner surface of the lens capsule changed their identity and behaved differently.” Some of these cells made their way into the lens, compromising lens function, according to the press release. The authors reported that it’s not yet known what is causing the cells to do this, but they advocated for further investigation to better understand the development of diabetic cataract and “the cellular processes underlying cataract development.”

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting, May 5–8, 2023, in San Diego, California, is ongoing. Get ready to “Make Waves” in education, innovation, and networking.
• ASCRS Annual Meeting Preview Program: The ASCRS Annual Meeting Preview Program is available online with more details about Annual Meeting schedules and programming.
• YES Connect Webinar: The latest YES Connect Webinar on “Corneal Topography Devices” is on demand online.

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Research highlights

• Retrospective data analysis in a private practice setting was conducted to develop and evaluate formulas for predicting postop vault after implantable collamer lens (ICL) surgery. The study, published in the Journal of Cataract & Refractive Surgery, included 115 eyes of 59 patients (all of whom were White and had varying degrees of ametropia) to train regression models that would predict postop vault based on AS-OCT parameters (the least absolute shrinkage and selection operator [LASSO] OCT formula), ocular biometry data (the LASSO biometry formula), and data from both devices. The authors wrote that the performance of the models was evaluated against the manufacturer’s nomograms (the Online Calculation and Ordering System [STAAR Surgical] and Nakamura 1 and 2 formulas) on a separate test set of 37 eyes of 19 patients. Overall, the authors found that the LASSO formulas were “powerful, reproducible,” and “convenient” for ICL sizing for eyes with low to moderate myopia. The authors wrote that this research provides important data about new ICL sizing formulas in a White patient population because the datasets that these formulas were trained on originally were primarily of Asian eyes with higher levels of myopia, and there is the possibility of racial ocular anatomy differences that could affect the formula’s performance in different patient populations.
• The outcomes and complications of pars plana vitrectomy for retained lens fragments after cataract surgery were evaluated in a retrospective case series published in the journal Clinical Ophthalmology. The study, which reviewed 246 eyes of 246 patients from 2012 through 2020 from Bascom Palmer Eye Institute, looked at the outcomes when the vitrectomy was performed on the same day as the original cataract surgery (n=140 eyes), within 1 week (n=33 eyes), and after 1 week (up to 90 days, n=73) after cataract surgery. According to the paper there were no statistically significant differences in mean BCVA between the groups. The authors found that when only eyes without known pre-existing ocular disease (n=157) were included, there were also no differences in mean BCVA between the groups. Rates of retinal detachment were similar between the groups as well.

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Product news

• Dr. Reddy’s Laboratories launched difluprednate ophthalmic emulsion, an FDA-approved generic equivalent to brand-name Durazol (Novartis), in the U.S. market.
• The EyeArt AI eye screening system by EyeNuk, which is FDA approved in the U.S. for detecting diabetic retinopathy, was given clearance in the European Union for screening of AMD and glaucomatous optic nerve damage.

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