Tyrvaya (varenciline) Nasal Spray Approved by US Food and Drug Administration (FDA) for Dry Eye Treatment

Tyrvaya (varenciline), manufactured by Princeton, New Jersey–based drugmaker Oyster Point Pharma, is the first nasal spray to treat dry eye disease has recently won approval from the US Food and Drug Administration (FDA).

This marks a significant development for patients suffering from moderate-to-severe dry eye. Sprayed twice daily into the nostrils, 0.03-mg varenciline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments.

Varenicline is a safe and effective way to help relieve dry eye disease symptoms for those who have not been able find relief with artificial tears or if they need more than the typical use of 3-4 times per day.

Tyrvaya harnesses cholinergic activity (promoting parasympathetic nervous system processes) to transport medication through the mucous membranes to the trigeminal nerve pathways and into the ophthalmic nerve, to stimulate the nicotinic receptors housed there, which then causes natural tears to be created that help relieve symptoms of dry eyes.

The spray works in as little as 14 days, and doesn’t irritate eyes. In 47% of patients who were given varenicline instead of a placebo eye drops, Schirmer test scores increased by 10 mm within just one month.

Almost all patients who took varenicline had some  sneezing, but almost no ocular side effects. There were no reports of burning or stinging; instead some patients experienced some coughing and throat irritation.

Assessment of Patient Compliance in Orthokeratology

Abstract

Background: Patient non-compliance, that is, failure to perform standard wear and care orthokeratology (ortho-k) lenses procedures, has been shown to be a major risk factor for contact lens-associated complications. Therefore, this study aimed to investigate the compliance with wear and care behaviors of ortho-k patients and analyze its influencing factors.

Methods: Patients who were successfully prescribed ortho-k lenses at the Eye Center of the Second Affiliated Hospital of Zhejiang University School of Medicine (ECSAHZU) were enrolled in the study. Patient compliance with wear and care behaviors was examined through a questionnaire.

Results: This study assessed 238 subjects. The subjects’ ages ranged from 7 to 25 (mean ± SD, 11.3 ± 2.5) years. The compliance with wear and care behaviors was 19.7%, and the subjects’ self-assessment compliance was 96.6%. The compliance rate of subjects wearing lenses for less than 1 year was higher than that of subjects wearing lenses for more than 1 year (p < 0.001). In the first year, the compliance rates of wearing experiences for less than 1 month, 1 month, 3 months, 6 months, and more than 6 months were 45, 29, 21.6, 20, and 27.6%, respectively, and there were no statistically significant differences in compliance among these periods (p = 0.314). No correlation was identified between compliance and age (r = – 0.061, p = 0.527) or sex (r = 0.114, p = 0. 751). There was no correlation between compliance and lens care operator (r = – 0.626, p = 0.151).

Conclusions: The compliance of ortho-k patients was poor. After wearing ortho-k lenses for more than 1 year, compliance with wear and care behaviors declined. In clinical practice, measures should be taken to solve these problems and improve the safety of wearing ortho-k lenses.

Bian Z, Xu X, Chen D, Ni H. Assessment of patient compliance in orthokeratology and analysis of influencing factors: a cross-sectional study. BMC Ophthalmol. 2021 Nov 16;21(1):396. doi: 10.1186/s12886-021-02148-2. PMID: 34784895; PMCID: PMC8594163.

The Vision-related Burden of Dry Eye

Purpose

To investigate the relationship between dry eye disease (DED) and vision-related quality of life (VR-QoL) at population level.

Methods

DED and VR-QoL were assessed in 89,022 participants (18–96 years, 59% female) from the Dutch population-based Lifelines cohort using the Women’s Health study (WHS) and Visual function 25 (VFQ25) questionnaires. The relationship between DED and compromised VR-QoL was assessed with logistic regression, corrected for age, sex, BMI, income, education, smoking, and 55 comorbidities.

Results

9.1% of participants had DED. The participants with DED had higher risk of compromised average of ten domains of VR-QoL (OR 3.12 (95% CI 2.98–3.27) corrected for age, sex, BMI, income, smoking, and 55 comorbidities). Increasing symptom frequency was highly associated with decreasing VR-QoL (P < 0.0005). In all VR-QoL domains, including measures of daily visual function and emotional well-being, DED was clearly associated with compromised VR-QoL. Compared to macular degeneration, glaucoma, retinal detachment, and allergic conjunctivitis, DED presented similar or higher risks for compromised score on all VR-QoL domains. The population-attributable fraction of DED for compromised general vision exceeded that of other eye diseases investigated, especially in the younger age groups.

Conclusion

DED is associated with reductions in all domains of VR-QoL, also after correction for associated comorbidities. We found that DED imposes an extensive population burden regarding compromised VR-QoL due to its high prevalence and substantial impact on VR-QoL, higher than that for other common vision-affecting eye disorders. Our results emphasize the importance of recognizing DED as a serious disorder from both patient and public health perspectives.

Mathias Kaurstad Morthen, Morten Schjerven Magno, Tor Paaske Utheim, Harold Snieder, Nomdo Jansonius, Christopher J. Hammond, Jelle Vehof, The vision-related burden of dry eye, The Ocular Surface, 2021,

https://doi.org/10.1016/j.jtos.2021.10.007

Seven-Year MiSight 1 Day Contact Lens Study Indicates No Myopia Control Rebound in Children

CooperVision released new seven-year results from its crucial MiSight 1 day contact lens clinical trial on Tuesday. The firm, a global leader in myopia control and management for children, stated that 12 months after treatment discontinuation, mean axial elongation data show no sign of rebound impact, indicating that myopia control advantages are sustained. CooperVision presented the study’s findings during a special event here, as eye doctors gathered for the start of the American Academy of Optometry’s annual Academy meeting which runs from November 3 through the 6th 2021.

According to CooperVision, the multinational study is the world’s longest continuous running soft contact lens clinical trial for myopia control. CooperVision previously claimed that MiSight 1 day slowed myopia progression after numerous years of treatment. This was shown in a cohort that wore MiSight 1 day for the first six years of the trial, as well as the original control group, which was transferred to MiSight 1 day for three years.

MiSight 1 day contact lenses are specifically designed for myopia control and are FDA approved to slow the progression of myopia in children aged 8-12 at the initiation of treatment. In August, MiSight 1 day received approval from the Chinese National Medical Products Administration (NMPA) to become the first indicated product of any type that may slow the progression of axial length.

FDA Approves VUITY™ for the Treatment of Presbyopia

Allergan announced the U.S. Food and Drug Administration (FDA) approval of VUITY (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this common and progressive eye condition that affects 128 million Americans, nearly half of the U.S. adult population.

As we age, presbyopia (impaired near vision) becomes a common problem for adults. When reaching the age of 40 or so, many people start using reading glasses, holding material farther away, or even raising the font size and illumination on screens in an attempt to improve their vision 

After 15 minutes and lasting up to six hours, VUITY is a daily, prescription eye drop that improves near and intermediate vision without affecting distance vision. An established eye-care treatment, pilocarpine, is improved in VUITY for presbyopia and given with pHast™ technology. pHast™ technology enables VUITY to swiftly adjust its pH to the tear film’s physiologic PH. VUITY uses the eye’s natural ability to shrink pupil size to improve near vision without impacting far vision.

“As we age, the lenses of our eyes become less flexible, making it more difficult to focus on things up close. VUITY offers a novel, safe, well-tolerated and effective alternative to current options for managing age-related blurry near vision,” said George O. Waring IV, M.D., FACS, medical director, Waring Vision Institute, South Carolina, and GEMINI 1 and GEMINI 2 principal study investigator. “I am particularly encouraged by the rapid onset of action and duration of efficacy for VUITY to improve near and intermediate vision without impacting distance vision with one drop daily, particularly for those with mild to moderate presbyopia.”  

Based on findings from two key phase 3 clinical studies, GEMINI 1 and GEMINI 2, the FDA has approved VUITY for the treatment of presbyopia based on its efficacy, safety, and tolerability. On day 30 of both experiments, VUITY satisfied the primary goal, which was statistically significant improvement of close vision in low light (mesopic) circumstances without a loss of distance vision. Even after just 15 minutes, a noticeable difference could be detected and lasted for six hours. The GEMINI 1 and GEMINI 2 studies found no significant side effects in subjects who received VUITY. Headaches and eye redness were the most common side effects that occurred more than 5% of the time.