- Study: Possible therapy to avoid visual problems induced by space travel
- Exploratory study finds investigational eye drop for dry eye safe and tolerable
- New drug candidate in development to treat dry eye and ocular pain
- Results from year 2 of Phase 3 trial of brolucizumab for DME
- ASCRS news and events
December 17, 2021 • Volume 27, Number 49
Study: Possible therapy to avoid visual problems induced by space travel
Research published in the journal JAMA Ophthalmology described a possible treatment/preventative measure against space-associated neuro-ocular syndrome (SANS), a condition brought on by extended time spent in a microgravity environment. Researchers, according to the paper, hypothesize that SANS is brought on by the “absence in diurnal reductions in intracranial pressure” due to a lack of gravity in space. This creates a “low but persistent pressure gradient at the posterior aspect of the eye.” The investigators conducted a randomized crossover study with 10 participants in a microgravity simulation to evaluate a possible remedy called lower body negative pressure (LBNP), where a chamber the participant sleeps in induces “footward fluid shifts.” The participants spent 3 days in a supine position with and without the LBNP treatment during 8 hours of sleep. The investigators described observing choroid engorgement, which they said is an early biomarker of SANS, after 3 days of bedrest. They also reported a “sustained reduction in supine central venous pressure” and a reduced increase in the choroid area and its volume in patients treated with LBNP compared to control. They concluded that LBNP could be an “effective countermeasure for ocular remodeling and SANS.”
Exploratory study finds investigational eye drop for dry eye safe and tolerable
Kiora Pharmaceuticals announced topline data from its exploratory study of KIO-101 that found it to be safe, tolerable, and meriting advancement into a Phase 2 study. The company described KIO-101 as a nonsteroidal, immunomodulatory, small molecule inhibitor of dihydroorotate dehydrogenase. According to the company, the mechanism blocks T cell proliferation and pro-inflammatory cytokine release. The most recent study enrolled 24 healthy patients and 21 patients with ocular surface inflammation. In addition to safety and tolerability, the study observed statistically significant improvements in conjunctival hyperemia. There was a trend in favor of improved ocular surface disease index scores, but the company stated that there was no statistically significant difference in tear breakup time, corneal staining, conjunctival staining, or other exploratory endpoints.
New drug candidate in development to treat dry eye and ocular pain
OKYO Pharma announced its drug candidate OK-101, which is being developed to treat dry eye disease, shows promise for reducing ocular pain. According to the company, OK-101 was developed to treat dry eye disease as an anti-inflammatory, but in a mouse model of corneal neuropathic pain, it is showing potential to treat both pain and inflammation at the same drug concentration. According to the press release, OKYO is completing pre-IND work for OK-101 and plans to file the IND for the drug to treat dry eye disease in the third quarter of 2022 with a Phase 2 trial to follow.
Results from year 2 of Phase 3 trial of brolucizumab for DME
Novartis announced positive results from year 2 of its Phase 3 clinical trial for Beovu (brolucizumab) 6 mg for patients with visual impairment due to DME. According to the company’s press release, these results confirm findings from year 1 of the study, which found a favorable risk/benefit profile and showed visual acuity gains and sustained reductions in central subfield thickness. The company also noted that more patients who received Beovu in the trial had resolution of intraretinal and/or subretinal fluid at year 2 vs. those assigned to receive aflibercept. Seventy percent of patients remained on a 12-week dosing schedule through year 2, after the loading phase, which Novartis suggests could mean fewer injections for patients with Beovu vs. aflibercept.
ASCRS news and events
- 2022 ASCRS Annual Meeting: Tier 1 registration for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022, is open through January 12. There is also an open call for complicated case video submissions.
- ASCRS Winter Symposium: Registration is open for the February 10–12 Winter Symposium in Park City, Utah. The meeting focuses on the innovative techniques and controversies in anterior segment ophthalmology.
- Beyond 20/20: Beyond 20/20: An ASCRS Series in Modern Refractive Surgery and Presbyopia Therapy is a four-part educational program sponsored by the Refractive Clinical Committee that features CME and non-CME components. Learn more about the program and register here.
Research highlights
- Corneal biometric features and their association with axial length in high myopia were investigated in a cross-sectional comparative study that included 299 highly myopic eyes and 266 age- and sex-matched control eyes. Central corneal thickness (CCT), thinnest corneal thickness (TCT), corneal volume (CV), and anterior, posterior, and total corneal curvature were smaller in patients with high myopia compared to controls. The authors noted that CCT, TCT, and CV showed a continuous downward trend with axial length and corneal curvature decreased with axial length when axial length was less than 26 mm (slope decreased when axial length was 26–28 mm). The authors reported that this linear association was not present when the axial length was longer than 28 mm. Anterior, posterior, and total corneal curvatures were negatively associated with axial length when the axial length was less than 26 mm and when it was between 26–28 mm. With this, the authors concluded that “consideration should be given to the special distribution of corneal curvature for IOL calculations in subjects with high myopia.” The research is published in the American Journal of Ophthalmology.
- With the negative effects associated with long-term steroid use, immunosuppressants are being researched in terms of safety and efficacy for treatment of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC). Research published in the journal Cornea evaluated topical tacrolimus ophthalmic suspension, an antibiotic drug with immunosuppressive effects, in 26 eyes of 26 patients with VKC and AKC over a 2-year treatment period. The study found that papillae-limbus-cornea scores at 6 months were significantly improved compared to baseline, and those recorded at months 18, 21, and 24 were significantly improved compared to month 6. Remission rates also increased, with the authors reporting 92% in remission at 24 months. Logistic regression analysis showed for every 10-year increase in age, the risk for needing additional steroid eye drop therapy was reduced by half with tacrolimus therapy. The authors concluded that topical tacrolimus was “an effective method for inducing and maintaining the stable stages of VKC and AKC.”
Product news
- VUITY (pilocarpine HCI ophthalmic solution, Allergan) is now available with a prescription for the temporary correction of presbyopia.
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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