- FDA approves new presbyopia-correcting IOL
- New way to evaluate sickle cell retinopathy
- Positive Phase 2a data on novel, topical dry eye disease drug candidate
- Second Phase 3 trial initiated for Demodex blepharitis treatment
- Large-scale, randomized controlled trial replicated with real-world data set
- ASCRS events
May 14, 2021 • Volume 27, Number 19
FDA approves new presbyopia-correcting IOL
The FDA has approved Johnson & Johnson Vision’s TECNIS Synergy and TECNIS Synergy Toric II IOLs, presbyopia-correcting IOLs that, according to the company’s press release, provide continuous range of vision at all distances and better contrast sensitivity even in low light. A company-sponsored study found that 9 out of 10 patients who received TECNIS Synergy IOLs did not need glasses. In addition to FDA approval, the company announced approval by Health Canada for the TECNIS Synergy Toric II, with the non-toric version already having approval. The lenses will be commercially available in the U.S. by this summer.
New way to evaluate sickle cell retinopathy
Ophthalmologists at New York Eye and Ear Infirmary of Mount Sinai reported a new way to evaluate patients with sickle cell retinopathy using OCT-A as a potential method to prevent progression and vision loss. The research published in the journal Biomedical Optics Express included 27 patients, 13 of whom had sickle cell disease with retinopathy and 14 of whom didn’t, serving as controls. Some patients with sickle cell were on hydroxyurea as therapy, others weren’t. The investigators took 10 OCT-A scans of participants within 10 minutes and repeated imaging an hour later, specifically looking at blood vessels that opened and closed, a press release about the research explained. Patients without sickle cell disease had blood vessels that remained open for the most part, while patients with sickle cell who weren’t on therapy had more “flickering” of their blood vessels (intermittent blood flow) compared to those on treatment. The researchers created a computer algorithm based on their observations to assess risk of retinal blood blockages that could lead to vision loss. The press release stated that this technique could be used to assess which therapies work best for patients.
Positive Phase 2a data on novel, topical dry eye disease drug candidate
Oculis announced positive Phase 2a data supporting the proof-of-concept for its novel, topical, anti-TNF alpha antibody fragment OCS-02 for dry eye disease. According to the company’s press release, OCS-02 was significantly more effective than the vehicle in this study in relieving severe ocular discomfort related to dry eye disease. More specifically, the press release noted a significant association between response to this agent and patients with a genetic biomarker. The company stated the need for additional studies to better understand the role of gene variants in dry eye disease and efficacy of anti-TNF alpha therapies.
Second Phase 3 trial initiated for Demodex blepharitis treatment
Tarsus Pharmaceuticals is beginning a second pivotal trial (Saturn-2) to evaluate TP-03 as a treatment for Demodex blepharitis. According to the company’s press release, TP-03 is a topical ophthalmic formulation of lotilaner, an anti-parasitic agent. The trial’s primary endpoint is patients achieving collarette cure, with 0–2 lashes with collarettes. Secondary endpoints are eradication of the mites and a composite of collarette cure and erythema cure. Topline results from the company’s other Phase 2 pivotal trial, Saturn-1, are expected in July.
Large-scale, randomized controlled trial replicated with real-world data set
Verana Health announced the first time real-world data was used to replicate two large-scale randomized controlled trials (RCTs) in ophthalmology. According to the company’s press release, the VIEW 1 and VIEW 2 trials, which led to FDA approval of aflibercept (Eylea, Regeneron) for wet AMD in 2011, were the RCTs that served as the basis for the real-world data comparison. Using data from the IRIS Registry (American Academy of Ophthalmology) with the same inclusion and exclusion criteria as the VIEW 1/2 studies applied and the same study design, the investigators identified 4,779 patients in the registry to compare to the original studies’ 1,632 patients. The researchers found that the proportion of eyes losing 15 ETDRS letters in the VIEW 1/2 studies was similar to the real-world data from the IRIS Registry. The company’s press release about this research stated that this replication of Phase 3 RCTs using a real-world data set shows the potential to validate trial endpoints to measure efficacy of treatment.
ASCRS events
- The next ASCRS Ground Rounds is set for May 19 at 8:30 p.m. ET.
- Glaucoma Building Blocks, an educational series for comprehensive glaucoma management, begins May 25.
- The Challenging Cases in Cataract Video Symposium at the ASCRS Annual Meeting is accepting submissions through May 31.
- The “skip-the-line” deadline for the 2021 ASCRS Annual Meeting in Las Vegas, Nevada, July 23–27, is coming. If you want your badge mailed to you, register and select the mailing option by June 1.
Research highlights
- With long-term spaceflight of a year or more planned, researchers are evaluating neuro-ocular syndrome experienced by astronauts. Year-long data of two male astronauts on the International Space Station, with measurements and testing taking place before spaceflight, during, and up to a year after return to Earth, showed late development of mild optic disc edema in one study participant and progressive development of choroidal folds and optic disc edema in the other, according to the findings published in JAMA Ophthalmology.
- Researchers in Spain developed a risk prediction model for endothelial keratoplasty (EK) after uncomplicated cataract surgery in patients who had Fuchs. The research to develop this model included 127 eyes from 93 consecutive patients. Corneas were assessed with Scheimpflug imaging pachymetry and elevation maps for loss of regular isopachs, displacement of the thinnest point, and posterior surface depression, according to the paper. In this set, 44 patients required EK. The investigators reported the best predictive model was the number of tomographic features present in the eye and central corneal thickness at the pupillary center. A risk score from 0–8 was developed. According to the paper, EK was nearly 0 for patients with a risk score of less than 4 and was almost 100% for those with a score of 8. This research is published in the American Journal of Ophthalmology.
Product news
- Alcon gained exclusive rights to sell BlephEx and its accompanying products in the U.S.
- Ziemer announced the launch of its FEMTO Z8 NEO, a femtosecond laser platform for refractive, therapeutic, and cataract surgery that can be wheeled in and out of the OR, according to the company.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
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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