EW Weekly, December 18, 2020

COVID-19 vaccine update
Last week, the FDA issued emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, the first to become available in the U.S. On Thursday the FDA’s Vaccines and Related Biological Products Advisory Committee recommended that the FDA authorize emergency use of the Moderna COVID-19 vaccine. The FDA’s final decision on EUA for the Moderna vaccine is expected Friday. The Pfizer-BioNTech vaccine began distribution with administration of the first doses in the U.S. Monday. The CDC recommended a phased allocation process with the first doses of the limited supply being recommended to healthcare personnel and residents of long-term care facilities. All physicians are included in this initial phase, but allocation of the currently limited vaccine is ultimately up to state and local governments. The prioritization will likely be based on risk, such as those who are on the frontlines treating or in frequent possible contact with COVID-19 patients, those in emergency medicine, critical care, and others. As availability of the vaccine increases, recommendations for who should be vaccinated next will be expanded. Phase 1b in the CDC’s recommendations includes essential workers, such as those working in the education sector, in the food and agriculture industry, utilities, police, firefighters, corrections officers, and transportation employees. Phase 1c includes adults with high-risk medical conditions and those who are 65 years and older.

Phase 2b trial for blepharitis treatment
Nicox began its Mississippi Phase 2b trial to evaluate one-daily NCX 4251, 0.1%, vs. placebo as a possible first-in-class treatment for patients with acute exacerbations of blepharitis. NCX 4251 is an ophthalmic suspension of fluticasone propionate nanocrystals designed for direct application to the eyelids to target the site of the inflammation while minimizing the intraocular exposure to the steroid, the company’s press release stated. The trial is expected to enroll and randomize 200 patients at up to 10 U.S. sites. The primary outcomes will be the proportion of patients achieving complete cure of eyelid redness, eyelid debris, and eyelid discomfort, the press release continued. Topline results are expected by the fourth quarter of 2021. Safety and tolerability of NCX 4251 were established in the company’s Phase 2 Danube trial.

Phase 2 results from study evaluating melanocortin pathway for dry eye treatment
Palatin Technologies announced positive Phase 2 results for its study of PL9643 in patients with dry eye disease. PL9643 modulates the activity of melanocortin peptide receptor systems, according to the company’s press release. A statistically significant improvement in multiple signs and symptoms was observed by the study, as well as safety and tolerability. Statistical significance of the study’s primary endpoints at 12 weeks was not reached in the population that included a range of mild to severe dry eye patients, but the company’s press release stated that statistical significance was achieved in moderate to severe patients. The company plans to begin a Phase 2/3 trial in the U.S. in 2021.

Update in gene therapy trials
REGENXBIO announced dosing of the first patient in its Phase 2 ALTITUDE study evaluating suprachoroidal delivery of RGX-314 for diabetic retinopathy. According to the company’s website, RGX-314 is a one-time treatment of a gene for a monoclonal antibody fragment intended to produce longer term anti-VEGF activity. The trial will enroll about 40 patients with diabetic retinopathy in two cohorts, the company’s press release stated, with initial results reported in 2021. Separately, GenSight Biologics announced the publication of its Phase 3 REVERSE trial of LUMEVOQ, a gene therapy for ND4 Leber hereditary optic neuropathy. The REVERSE trial saw improvement of +15 ETDRS letters over baseline in average BCVA at 96 weeks post-injection. Patients’ contralateral eye was injected with a placebo, which resulted in a mean +13 ETDRS letters improvement over baseline. This latter improvement was not expected. A non-human primate study where LUMEVOQ was injected in one eye found that there was transfer of viral vector DNA from the injected eye to the anterior segment, retina, and optic nerve of the non-injected eye, which according to the company’s press release could provide a plausible mechanistic explanation for the bilateral improvement seen in the REVERSE trial. Eighty-one percent of patients in the REVERSE trial saw a clinically relevant recovery from the nadir in one or both eyes. The company applied for marketing authorization for LUMEVOQ to the European Medicines Agency in September and expects a decision by the fourth quarter of 2021.

Research briefs
  • A case series published in JAMA Ophthalmology looked at real-time incision-related Descemet membrane detachment to better understand when and how it occurs in cataract surgery. In the series of 133 patients, Descemet membrane detachment occurred in 125 operations, most frequently during phacoemulsification (69 cases) and irrigation-aspiration (44 cases). According to the study authors, these findings suggest that Descemet membrane detachment is most likely to occur during points of surgery with the most friction at the incision site. They also found that the severity of the detachment is associated with the level of ultrasonic energy and length of phaco time. “Decreasing ultrasonic energy and phacoemulsification time may reduce the severity of incisional DMD,” the authors concluded.
  • Long-term outcomes of SMILE in patients with high or low levels of astigmatism were evaluated in a study published in the British Journal of Ophthalmology. Forty-three eyes had 2 D or more of astigmatism (considered the high astigmatism group) and 31 eyes had 1 D or less. The outcomes were evaluated at 4 years postop. Residual cylinder at 4 years in the high astigmatism group was −0.31±0.29 D and −0.20±0.28 D in the low astigmatism group. The study authors reported an efficacy index of 0.99±0.14 and 1.10±0.21 in the high astigmatism and low astigmatism groups, respectively, and a safety index of 1.11±0.20 and 1.22±0.21. Eighty-six and 90.3% of eyes were within ±0.50 D of intended cylinder correction in the high and low astigmatism groups, respectively. According to the researchers, these findings and others show that SMILE is safe and effective for correcting high astigmatism, though vector analysis did reveal a trend toward under correction of astigmatism in this group.

Product news
  • Optos announced several advancements to its ultra-widefield imaging devices. Its Daytona device has improved optics and image capture time and an updated design/user interface. Silverstone now has a repeat scan tool for monitoring change over time, a new mode that displays OCT scan type and location on the optomap image, and auto contrast angiography capture. All devices in the Optos platform also now have optomap image enhancements.
  • Medmont International launched the medmont meridian Advanced Topographer, which in addition to topography includes anterior and fluorescein imaging and videos and dry eye evaluation tools.
  • Cassini Technologies announced that cOS 6.0 software for the Catalys Precision Laser System (Johnson & Johnson Vision) and its Cassini Ambient are now compatible and commercially available.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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