Friday, October 7, 2011

Device news: Lipiflow gets more money

For those of you waiting for Lipiflow to come to a dr. near you... with a fresh $15million going into the effort it may not be too long.

TearScience lands $15M to bring novel dry eye treatment to market

Medical device company TearScience has secured $15 million in debt financing that the company will use to support a pair of products addressing evaporative dry eye.....TearScience has U.S. Food and Drug Administration clearance on two products for dry eye. LipiView, which allows doctors to view the tear film and diagnose the condition. LipiFlow uses a combination of heat and pressure to treat it. Both diagnosis and treatment can be done in a physician’s office. LipiView was FDA-cleared in 2009. LipiFlow received FDA clearance earlier this year. The company also has marketing certification for the products in Europe.

Abstract: Functional visual acuity and tear function

The relation of functional visual acuity measurement methodology to tear functions and ocular surface status.

To investigate the relation of functional visual acuity (FVA) measurements with dry eye test parameters and to compare the testing methods with and without blink suppression and anesthetic instillation.

A prospective comparative case series.

Thirty right eyes of 30 dry eye patients and 25 right eyes of 25 normal subjects seen at Keio University School of Medicine, Department of Ophthalmology were studied. FVA testing was performed using a FVA measurement system with two different approaches, one in which measurements were made under natural blinking conditions without topical anesthesia (FVA-N) and the other in which the measurements were made under the blink suppression condition with topical anesthetic eye drops (FVA-BS). Tear function examinations, such as the Schirmer test, tear film break-up time, and fluorescein and Rose Bengal vital staining as ocular surface evaluation, were performed.

The mean logMAR FVA-N scores and logMAR Landolt visual acuity scores were significantly lower in the dry eye subjects than in the healthy controls (p < 0.05), while there were no statistical differences between the logMAR FVA-BS scores of the dry eye subjects and those of the healthy controls. There was a significant correlation between the logMAR Landolt visual acuities and the logMAR FVA-N and logMAR FVA-BS scores. The FVA-N scores correlated significantly with tear quantities, tear stability and, especially, the ocular surface vital staining scores.

FVA measurements performed under natural blinking significantly reflected the tear functions and ocular surface status of the eye and would appear to be a reliable method of FVA testing. FVA measurement is also an accurate predictor of dry eye status.

Jpn J Ophthalmol. 2011 Sep;55(5):451-9. Epub 2011 Jun 30.
Kaido M, Ishida R, Dogru M, Tsubota K.
Department of Ophthalmology, Keio University School of Medicine, Shinanomachi 35, Shinnjuku-ku, Tokyo, Japan.

Abstract: Mucous production and cationized gelatin nanoparticles

Obviously very technical topic but we don't see a lot these days about mucin secretagogues so I thought those who follow those developments might like to see this one.

Expression of MUC5AC in Ocular Surface Epithelial Cells Using Cationized Gelatin Nanoparticles.

Decreased production of the mucin MUC5AC in the eye is related to several pathological conditions, including dry eye syndrome. A specific strategy for increasing the ocular levels of MUC5AC is not yet available. Using a plasmid specially designed to encode human MUC5AC, we evaluated the ability of hybrid cationized gelatin nanoparticles (NPs) containing polyanions (chondroitin sulfate or dextran sulfate) to transfect ocular epithelial cells. NPs were developed using the ionic gelation technique and characterized by a small size (< 200 nm), positive zeta potential (+20/+30 mV), and high plasmid association efficiency ( >95%). MUC5AC mRNA and protein were detected in conjunctival cells after in vitro transfection of the NPs. The in vivo administration of the NPs resulted in significantly higher MUC5AC expression in the conjunctiva compared to untreated control and naked plasmid. These results provide a proof-of-concept that these NPs are effective vehicles for gene therapy and candidates for restoring the MUC5AC concentration in the ocular surface.

Mol Pharm. 2011 Oct 3;8(5):1783-8. Epub 2011 Aug 2.
Konat Zorzi G, Contreras-Ruiz L, Párraga JE, López-García A, Romero Bello R, Diebold Y, Seijo B, Sánchez A.
Department of Pharmacy & Pharmaceutical Technology, Faculty of Pharmacy, University of Santiago de Compostela , Campus Sur, 15782, Spain.

Wednesday, October 5, 2011

Abstract: Tears Again Hydrate (with and without Restasis)

This is rather an interesting study and since the full text is available free you can easily review the details. They compared a group who took Tears Again Hydrate (flaxseed and evening primrose oil supplement sold on prescription) for six months with a group who took that AND took Restasis for the last 3 months of the 6 month period. In this study it didn't appear that Restasis added much.

Efficacy of a new prescription-only medical food supplement in alleviating signs and symptoms of dry eye, with or without concomitant cyclosporine A.

To evaluate the effect of a new, prescription-only medical food supplement containing omega-3 and omega-6 essential fatty acids on dry eye signs and symptoms, with or without concomitant topical cyclosporine.

A total of 43 subjects were randomized and followed for 6 months. Group 1 (n = 23) was assigned to take two soft geltabs of the medical food supplement by mouth twice daily for 6 months. Group 2 (n = 20) was directed to take the medical food supplement in the same manner, along with topical cyclosporine, instilled twice daily during the last 3 months of the study. Subjects were evaluated at baseline, month 1, month 3, and month 6. Primary outcome measures included tear breakup time (TBUT), conjunctival staining, corneal staining, and change in subjective symptoms.

Both groups had a statistically significant improvement in TBUT between baseline and month 6. In the food supplement only group, TBUT improved by 0.805 seconds from baseline to month 6. In the supplement/cyclosporine group, TBUT improved by 1.007 seconds from baseline. There was no statistically significant difference in TBUT between the two groups at baseline, month 3, or month 6. There were no significant differences in corneal or conjunctival staining between or within groups. Subjective symptoms were also improved in both groups.

Supplementation with the proper balance of omega-3 and omega-6 essential fatty acids improved TBUT and relieved patient symptoms. The addition of topical cyclosporine did not convey any statistically significant improvement in TBUT beyond that achieved by the supplement.

Clin Ophthalmol. 2011;5:1201-6. Epub 2011 Aug 25.
Jackson MA, Burrell K, Gaddie IB, Richardson SD.
Jacksoneye, Lake Villa, IL, USA.

Monday, October 3, 2011

Abstract: Inflammatory process or no?

This is an interesting study in IOVS looking at inflammatory cytokines in "pure" lipid-deficient dry eye versus aqueous deficient or combo. Their conclusion was that based on the minimal protein quantities in the "pure" lipid deficient cases (i.e. no aqueous deficiency), the disease process is not based on inflammation.

Proinflammatory Cytokine Profiling of Tears from Dry Eye Patients by Means of Antibody Microarrays.
Purpose. In the pathogenesis of keratoconjunctivitis sicca, immune processes are thought to play an important role. However, the exact details of the pathomechanisms are still unknown. In this study, the expression patterns of proinflammatory cytokines in the tears of patients with different subtypes of dry eye were analyzed. Methods. One hundred forty-three subjects subdivided into healthy controls (CTRL, n = 38), patients with aqueous-deficient dry eye (DRYaq, n = 35), patients with changes of the lipid layer (DRYlip, n = 36), and patients with a combination of both (DRYaplip, n = 34) were examined. Expression patterns of proteins (e.g., IL-1β, IL-6, ITNF-α, and IFN-γ) were examined using an advanced antibody microarray approach. Results. Several highly significant differences in the cytokine levels of dry eye patients compared with healthy controls were detected. Patients with DRYaq or those with DRYaplip showed elevated levels for most of the tested proteins. For example, IL-1β was found to be elevated 2.4-fold in DRYaq patients and 2.75-fold in DRYaqlip patients (both P < 8.00E-6). The detected amounts of protein in DRYlip patients and in healthy controls showed only minimal differences (fold increase/decrease for all proteins >1.2; P > 5.00E-1). Conclusions. The similarity between the profiles of healthy controls and DRYlip patients justifies the assumption that the pathomechanism of this dry eye subtype is based on mechanisms other than inflammation, whereas it seems to be the case for DRYaq patients.
FROM: Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7725-7730. Print 2011. Boehm N, Riechardt AI, Wiegand M, Pfeiffer N, Grus FH. Source Experimental Ophthalmology, Department of Ophthalmology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.

Abstract: Dry eye and juvenile rheumatoid arthritis

Relation of dry eye to disease activity in juvenile rheumatoid arthritis.
To study the frequency and severity of dry eye in patients with juvenile rheumatoid arthritis (JRA) and its relation to disease activity.
Patients and Methods.
Evaluation for dry eye was done in 40 patients with juvenile rheumatoid arthritis referred for ocular assessment in the Ophthalmology Clinics, Faculty of Medicine, Ain Shams University. They were 28 girls and 12 boys with age range of 7-12 years. Medical history, clinical examination, and full ophthalmologic evaluation were performed for each patient. The dry eye tests included tear film break-up time, Schirmer-1 test, and corneal fluorescein staining. Dry eye severity grading was used. Twenty healthy, age- and sex-matched children were assessed for dry eye as a control group.
Thirty patients (75%) showed findings consistent with the diagnosis of dry eye. Twenty patients (50%) showed first-degree dryness, 8 (20%) showed second-degree, and 2 (5%) showed third-degree. The score of dry eye severity was significantly lower in remission compared to disease activity. Multiregression analysis showed the only factor affecting dry eye parameters was the duration of illness.
Dry eye is a common incident in children with JRA and should be screened for in all patients with this disease. Severity of eye dryness is highly correlated with the disease activity.
Eur J Ophthalmol. 2011 Sep 7. pii: FD250C68-C164-4BCA-8ECD-0F12DCE1E97D. doi: 10.5301/ejo.5000042. [Epub ahead of print]El-Shazly AA, Mohamed AA.SourceDepartment of Ophthalmology, Faculty of Medicine, Ain Shams University, Cairo - Egypt.