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Sjögren's Disease
Published in Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide, Clinical Innovation in Rheumatology, 2023
Management of dry eye disease. A stepwise approach to the management of DED is recommended and is based on severity of symptoms and measures of ocular dryness (168). Topical cyclosporine drops were initially approved in 2003, but newer formulations (Cequa) are now available and the use of compounded solutions with higher drug concentration is more prevalent. In 2016, lifitegrast 5% ophthalmic solution was approved based on data from five randomized clinical trials. It acts via preventing recruitment and activation of T cells by targeting lymphocyte function-associated antigen-1 (169). Autologous serum tears can be compounded for severe DED. Their use is associated with relief that exceeds the lubrication effect when compared with artificial tears, although the therapeutic effect is short-lived (170). An intranasal stimulator of tear production was approved in 2017 but unfortunately was taken off the market in 2020 due to its high cost of manufacturing. The TrueTear® device stimulates the anterior ethmoid nerve, leading to increased lacrimation and improved symptoms (171). A significant proportion of SjD patients have meibomian gland dysfunction (MGD) in addition to inadequate tear production (172). This leads to tear film instability and increased evaporative tear loss. Traditionally, MGD is treated with eyelid hygiene, topical nonsteroidal anti-inflammatory agents, and antibiotics. Newer techniques seek to improve meibum secretion from the meibomian glands by decreasing its viscosity; these modalities include electronic heating devices, intense pulsed light therapy, and thermal pulsation (173, 174). Scleral lenses are an option for patients with dry eye symptoms refractory to other treatments; they completely vault the cornea, creating a liquid bandage that can lead to significant symptom relief (175).
A Comprehensive Review of the Clinical Trials Conducted for Dry Eye Disease and the Impact of the Vehicle Comparators in These Trials
Published in Current Eye Research, 2021
Kelly K. Nichols, David G. Evans, Paul M. Karpecki
The three pivotal trials for lifitegrast all used several outcome measurements and efficacy endpoints in their statistical design. In the OPUS-1 trial, outcome measures included subjective and objective assessment, including CFS, conjunctival staining, Schirmer’s test, a 7-item VAS, and the OSDI.14 The primary efficacy endpoint was mean change from baseline to day 84 in CFS score in the inferior corneal zone.16 Secondary endpoints included CFS scores in the other corneal zones, conjunctival staining scores, unanesthetized Schirmer’s test score, VAS, and OSDI scores.14 The OPUS-2 trial outcome measures included CFS scores, conjunctival staining, VAS, and ocular discomfort as graded by the patient.15 The co-primary efficacy endpoint was change from baseline to day 84 in eye dryness score (VAS) and in the CFS score in the inferior zone. Secondary endpoints included change from baseline to day 84 in ocular discomfort score, total CFS score, and nasal conjunctival staining score in the designated study eye, and eye discomfort score reported as a single score for both eyes.15 In the OPUS-3 trial, the outcome measures for dry eye were VAS (a 7-item, participant-reported symptom index) and ocular discomfort score (ODS).16 The primary efficacy endpoint was change from baseline to day 84 in the eye dryness subscale of the VAS, and secondary efficacy endpoints included change from baseline to each visit in VAS and ODS, as well as the overall tolerability of lifitegrast.16
In Vivo Effect of RSH-12, a Novel Selective MMP-9 Inhibitor Peptide, in the Treatment of Experimentally Induced Dry Eye Model
Published in Current Eye Research, 2021
Alireza Shoari, Mohammad Javad Rasaee, Mozhgan Rezaei Kanavi, Sasha Afsar Aski, Raheleh Tooyserkani
Dry eye syndrome (DES) is an ocular surface disorder affecting about 20% of American adults1 and presenting as ocular irritations, tear film instabilities, and visual perturbations.2 It occurs as the consequence of multiple factors such as immune disorders, certain medications, normal ageing processes, climatic conditions, computer overuse, contact lens wear, and post-refractive surgeries.3,4 Current medical therapies for DES include FDA-approved drugs such as Restasis (Cyclosporin A) and Lifitegrast (lymphocyte function-associated antigen-1 (LFA-1) antagonist),5 topical administration of artificial eye drops to moisturize corneal surface and prescription of topical anti-inflammatory medications such as corticosteroids.6 However, there are some reported side effects for Lifitegrast such as bad taste (dysgeusia), blurry vision, and eye burning and redness.7 In addition, frequent use of Restasis causes side effects such as ocular surface pain, irritation, and increased risk of viral and fungal infections because of “disruption” in normal functioning of the immune system.8 Use of corticosteroids in DES, due to side effects of glaucoma, cataract, infection, and delay in wound healing has also been limited.9,10 Therefore, designing new therapeutic compounds with high selectivity in the suppression of immune responses may lead to enhanced efficacy and reduced deleterious side effects such as infection and wound healing delay.
Emerging drugs for primary Sjögren’s syndrome
Published in Expert Opinion on Emerging Drugs, 2019
Saviana Gandolfo, Salvatore De Vita
The treatment of mucosal dryness, based on saliva stimulation, administration of saliva substitutes and eye lubricants or artificial tears, is mainly aimed to alleviate symptoms and prevent local complications. Mouth hygiene and regular ophthalmologist evaluations are strongly recommended. When the ocular involvement is more severe, the use of cyclosporine drops has been demonstrated to improve both subjective symptoms and objective tests [30]. More recently, the ocular topical therapy with lifitegrast has been approved for eye dryness. Lifitegrast, by inhibition of the integrin lymphocyte function-associated antigen 1 (LFA-1) from binding to intracellular adhesion molecule 1 (ICAM-1), down-regulates inflammation and meibomian gland dysfunction mediated by T lymphocytes, and proved efficacy in dry eye disease [31]. In refractory cases, autologous serum may be an effective option [27,32].