- Results from pivotal amblyopia trial
- Phase 2 clinical program for third-generation keratoconus treatment
- Study compares tolerability of standard drop vs. novel drug delivery device
- Phase 3 clinical studies for investigational presbyopia drop complete
- Orphan drug designation granted for fungal keratitis treatment
- Full rights regained for investigational dry AMD therapy
- ASCRS news and events
March 18, 2022 • Volume 28, Number 11
Results from pivotal amblyopia trial
NovaSight released results from its pivotal amblyopia trial that compared CureSight, a digital treatment, to the current standard of care, eye patching. According to the press release, this research is the first pivotal study where a digital device was shown non-inferior to eye patching for treatment of pediatric amblyopia. The study randomized 103 patients 4–9 years old, comparing improvement in visual outcomes, patient adherence, and patient satisfaction. The BCVA improvement at week 16 was larger in the group treated with CureSight compared to patching; significant stereo acuity improvement was observed in both groups. Mean adherence to CureSight treatment was 93%, and 93% of patients reported being likely or very likely to choose CureSight digital treatment over patching, according to the press release. The company described CureSight as a “digital device that trains the visual system to use both eyes simultaneously, while the user watches any streamed video content through red-blue treatment glasses,” using algorithm and eye-tracking technology.
Phase 2 clinical program for third-generation keratoconus treatment
Glaukos has begun a Phase 2 clinical program for its new third-generation iLink therapy for keratoconus treatment. According to the company’s press release, the platform consists of a novel, single-use drug formulation bioactivated through UV light delivery to the cornea, inducing the strengthening and stabilizing corneal crosslinking reaction. This latest generation therapy is “designed to customize the therapeutic capabilities [and] streamline the patient experience.” Randomized, controlled trials will be designed to evaluate the safety and efficacy of patient-customized treatments vs. non-customized crosslinking treatments. It will also evaluate a new investigational laser-based bioactivation system. Patients will be enrolled in clinical sites in the U.S., Europe, South America, and Asia. The follow-up period of the trials will be 6 months.
Study compares tolerability of standard drop vs. novel drug delivery device
Eyenovia reported on a study that compared tolerability of latanoprost+benzalkonium chloride (BAK) with its Optejet microdose technology delivery device and a standard drop. According to the company’s press release, the study found that conjunctival epithelial cells tolerated latanoprost+BAK delivered with the Optejet technology better than that delivered as a standard drop. The company reported that the Optejet technology allowed for similar results to BAK-free latanoprost and no-treatment controls in all measures (cell viability, cytotoxicity, apoptosis, ROS generation, and ATP generation).
Phase 3 clinical studies for investigational presbyopia drop complete
Orasis Pharmaceuticals announced the completion of two Phase 3 clinical trials for its presbyopia-correcting drop candidate, CSF-1. According to the company’s press release, NEAR-1 and NEAR-2 were multicenter, double-masked, parallel-group clinical trials that enrolled more than 600 participants in the U.S., evaluating safety and efficacy of CSF-1. Topline results will be announced at the ASCRS Annual Meeting in April.
Orphan drug designation granted for fungal keratitis treatment
SIFI, a pharmaceutical company based in Italy, received approval for its orphan drug designation application from the FDA for investigational polyhexanide for treatment of fungal keratitis. According to the company’s press release this anti-infective polymer disrupts cell membranes and chromosomes of the microorganisms. The company stated that there is currently one FDA-approved treatment for fungal keratitis in the U.S. (and one in three patients fail on this treatment); no approved treatments for fungal keratitis exist in Europe, Japan, and Asia. The company’s polyhexanide also has an orphan drug designation for Acanthamoeba keratitis with the FDA and EMA.
Full rights regained for investigational dry AMD therapy
Catalyst Biosciences regained full rights to CB 2782-PEG, an investigational treatment for dry AMD. According to the company’s press release these rights were returned from Biogen, and collaboration on this and other potential AMD treatments ended between the two companies.
ASCRS news and events
- 2022 ASCRS Annual Meeting: Register for the ASCRS Annual Meeting in Washington, D.C., April 22–26.
- Eyecelerator@ASCRS: Registration is open for Eyecelerator@ASCRS, taking place April 21 ahead of the ASCRS Annual Meeting in Washington, D.C.
- ASCRS Grand Rounds: The first ASCRS Grand Rounds of 2022, presented by NYU Langone Department of Ophthalmology, is available on demand.
- Ophthalmology Quicksand Chronicles: The popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, welcomed guest Amar Agarwal, MD, to kick off Season 2. Watch the podcast here.
Research highlights
- A prospective, longitudinal study evaluated the role of corneal hysteresis (CH) as a risk factor of central visual field (VF) progression in patients with glaucoma or who are glaucoma suspects. The study included 248 eyes of 143 subjects who were followed for an average of 4.8 years with a minimum of five visits that included visual field tests. Corneal hysteresis, according to the investigators, was significantly associated with 10-2 and 24-2 visual field progression in univariable trend-based analysis. Multivariable trend-based analysis showed lower corneal hysteresis was associated with a faster rate of decline in 10-2 mean deviation. It also was associated with an increased likelihood of 10-2 visual field progression. The authors concluded that lower corneal hysteresis is “associated with a statistically significant, but relatively small, increased risk of central VF progression on the 10-2 test grid,” and “given the substantial influence of central VF impairment on the quality of life, clinicians should consider using CH to assess the risk of progression in primary open angle glaucoma patients including those with early disease.” The study is published in the American Journal of Ophthalmology.
- A prospective, cross-sectional study evaluated the structural and functional changes of meibomian glands and how they correlated with subjective and objective dry eye parameters of patients with Stevens-Johnson syndrome. The study published in the American Journal of Ophthalmology included 60 patients with Sjogren’s with chronic ocular symptoms. The mean tear osmolarity, lipid layer thickness, Schirmer’s test-1, and tear breakup time were 322.70±17.82 mOsm/l, 53.07±27.0 nm, 6.62±5.74 mm, 3.38±1.90 seconds, respectively, according to the paper. Severe meibomian gland loss was observed in 65% of the lids; 61% of lids had no expressible glands; and the Meiboscore showed a positive correlation with SPEED scores, corneal staining scores, and meibum quality score. The authors stated that the study shows the need to evaluate meibomian gland structure and function in patients with Sjogren’s-related dry eye.
Product news
- LASTACAFT (alcaftadine ophthalmic solution, Allergan) is now available over the counter without a prescription for treatment of ocular allergies.
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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