Reckoning time: Was Restasis actually WORTH the billions spent on it by dry eye patients, insurance companies and HMOs?
Journal roundup: Therapeutics
Abstract: Topical drug effect on mucins and goblet cells
New drug CEQUA receives FDA approval
Study: Cyclosporine, with and without sodium hyaluronate, for MGD
Conclusion: It's a toss-up - that is, there was no significant difference in performance between cyclosporine and cyclosporine plus sodium hyaluronate. However, I'd love to know more about what sodium hyaluronate solution they were using - what the vehicle was, where it was derived from and so on. Devil's in the details - can't paint a broad brush across these things.
Int J Ophthalmol. 2018 Apr 18;11(4):593-600. doi: 10.18240/ijo.2018.04.09. eCollection 2018.
Clinical efficacy of combined topical 0.05% cyclosporine A and 0.1% sodium hyaluronate in the dry eyes with meibomian gland dysfunction.
Kim HY1, Lee JE2, Oh HN3, Song JW4, Han SY5, Lee JS6,7.
Abstract
AIM:
To investigate the efficacy of combined topical 0.05% cyclosporine A (CsA; Restasis®, Allergan pharmaceuticals, USA) and 0.1% sodium hyaluronate treatment in dry eyes with meibomian gland dysfunction (MGD).
METHODS:
In a retrospective analysis, 53 patients (106 eyes) with MGD were enrolled and performed lid warm massage for 10min daily and be instilled preservative free sodium hyaluronate 0.1% eye drops 4 times daily. Patients were divided into subjects treated with topical 0.05% CsA and preservative free sodium hyaluronate vehicle (experimental group, n=74 eyes) and subjects treated with the preservative free sodium hyaluronate vehicle (control group, n=32 eyes). They were evaluated at baseline and 1, 2, and 3mo for subjective symptoms and objective signs including tear film break-up time (tBUT), Schirmer test, corneal staining (CS) score, lid margin telangiectasia (LMT), meibomian gland secretion (MGS), and conjunctival injection (CI).
RESULTS:
In the short-term treatment, the experimental group showed a statistically significant improvement in the ocular surface disease index (OSDI; P<0.001), tBUT (P=0.004), Schirmer test score (P=0.008) and LMT (P=0.021) by repeated measure ANOVA. Additionally, mean changes from baseline in OSDI (P<0.001), tBUT (P=0.001), Schirmer test score (P=0.029), CS score (P=0.047), LMT (P=0.002), CI (P=0.030) were improved better in the experimental group than in the control group at 3mo. However, there was no significant difference between the two groups in MGS (P=0.67).
CONCLUSION:
In dry eyes with MGD, 0.05% CsA improves the tear film stability as well as subjective ocular discomfort, and is effective in controlling lid margin inflammation.
Delivering cyclosporine A with contact lenses
Contrary to the abstract title, there's nothing actually new about this (this review mentions some earlier papers about cyclosporine delivered in contacts), but it seems like it's been quite awhile since I've seen something new specifically on this approach. This particular abstract says absolutely nothing whatsoever about safety or adverse events.
Vestn Oftalmol. 2017;133(2):75-81. doi: 10.17116/oftalma2017133275-81.
[New approaches to the treatment of keratoconjunctivitis sicca].
[Article in Russian; Abstract available in Russian from the publisher]
Safonova TN1, Gladkova OV1, Novikov IA1, Boev VI1, Fedorov AA1.
Research Institute of Eye Disease, 11 A, B, Rossolimo St., Moscow, Russian Federation, 119021..
Abstract in English, Russian
A new method has been developed for the treatment of severe forms of keratoconjunctivitis sicca (KCS) that involves the use of an original cyclosporine A (CyA) saturated soft contact lens (SCL) together with preservative-free artificial tears therapy.
A new method has been developed for the treatment of severe forms of keratoconjunctivitis sicca (KCS) that involves the use of an original cyclosporine A (CyA) saturated soft contact lens (SCL) together with preservative-free artificial tears therapy.
AIM:
to evaluate the effectiveness of the newly developed treatment for KCS based on the use of medical SCL saturated with 0.05% CyA.
MATERIAL AND METHODS:
The patients (43 men, 60 eyes) with severe KCS were divided into 2 groups. Group 1 included 21 patients (30 eyes), who received artificial tears and wore 0.05% CyA-saturated silicone-hydrogel SCLs. Group 2 included 22 patients (30 eyes), who wore unsaturated original SCLs and received CyA instillations 2 times daily and, also, artificial tears. Apart from a standard ophthalmic examination, the assessment included Schirmer's test, Norn's test, vital eye stain tests, tear osmometry, laser confocal tomography of the cornea, optical coherence tomography of the anterior segment with meniscometry, impression cytology of the conjunctiva, tear pH measurement, plating of the content of the conjunctival cavity, measurement of the width of the palpebral fissure, and calculation of the ocular surface disease index. Treatment results were followed up at 1, 3, 6, and 12 months.
RESULTS:
The use of 0.05% CyA-saturated SCLs allows to halve treatment time for patients with severe KSC (down to 1 week - 1 month) as compared to unsaturated original SCLs in combination with 0.05% CyA instillations and to reduce it 5 times as compared to 0.05% CyA instillations only.
CONCLUSION:
The new method of KSC treatment that involves the use of medical SCL of original design (ensures even distribution of 0.05% CyA across the ocular surface) and preservative-free artificial tears has demonstrated high therapeutic effectiveness as compared to existing methods.