Tuesday, March 13, 2012

Speaking of Lipiflow...

Interesting article from last month mentions a few practical items that interested dry eye patients might want to know...

How TearScience’s dry eye treatment sparked a new FDA 510(k) strategy
(MedCity, Feb 7th)

One piece of the commercialization puzzle that TearScience has yet to solve is reimbursement. Insurers do not yet pay for LipiFlow treatment and though the company has applied to instate reimbursement, Willis estimates the entire process can take anywhere from three to 10 years. For now, patients pay between $1,400 and $1,900 out of pocket for a treatment on both eyes that lasts nine to 18 months. Willis said that considering that some people with moderate to severe dry eye are already spending up to $4,000 annually on other remedies, patients are willing to pay. For a physician’s practice, the entire TearScience diagnostic and treatment system costs about $100,0000.

Device news - NextGen Lipiflow cleared by FDA

...on February 1st. Yikes, I'm behinder than I thought I was. Sorry about that.

Abstract: Resolvins in future dry eye drugs

Resolvins as new fascinating drug candidates for inflammatory diseases.

New classes of lipids such as lipoxins, resolvins, protectins and maresin are found to promote the resolution of inflammation. The resolving actions of these endogenous lipids are mediated by membrane receptors such as lipoxin A4 receptor/formyl peptide receptor 2 (ALX/FPR2) and cysteinyl leukotriene receptor 1 (CysLT1). Further, there exists G protein-coupled receptor 32 (GPR32), chemokine receptor-like (CMLKLR), LTB4 receptor 1 (BLT1) and unidentified high-affinity surface binding receptors in human polymorphonuclear leukocytes (PMN). In particular, RX-10001 (resolvin E1) and RX-10004 (synthetic analog of resolvin, phase II) are being studied clinically in many inflammatory diseases including dry eye, retinal disease, asthma, inflammatory bowel diseases, rheumatic arthritis and cardiovascular diseases by Resolvyx Pharmaceuticals. These novel lipid classes of inflammation resolving mediators might offers new opportunities for candidates of drugs modulating chronic inflammatory diseases. Here, the progress of resolvins as new drug candidates is introduced and research on the resolution phase of inflammation is emphasized.

Arch Pharm Res. 2012 Jan;35(1):3-7.
Lee CH.
College of Pharmacy, Dongguk University, Goyang 410-820, Korea. uatheone@gmail.com

Abstract: Drop in goblet cell density after cataract surgery

This study used several metrics to evaluate ocular surface changes after cataract surgery. Apparently the only thing measured in this study that did not return to baseline within the study period was goblet cell density, which could explain a lot about why some people get significant dry eye symptoms after cataract surgery.

Changes in the tear film and ocular surface after cataract surgery.

To evaluate changes in corneal sensitivity, tear film function, and ocular surface stability in patients after cataract surgery.

This hospital-based prospective randomized trial included 48 eyes from 30 patients who underwent phacoemulsification. Slit-lamp examination, Schirmer test 1 (ST1), and measurement of corneal sensitivity and tear film breakup time (BUT) were performed for all patients 1 day before and 1 day, 1 month, and 3 months after surgery. In addition, conjunctival impression cytology from the temporal region of the conjunctiva was simultaneously performed.

Corneal sensitivity at the center and temporal incision sites had decreased significantly at 1 day postoperatively (P = .021, P < .001). However, the sensitivity had returned to almost the preoperative level 1 month postoperatively. The mean postoperative ST1 results were no different from preoperative values. On the other hand, BUT results had decreased significantly at 1 day postoperatively (P = .01) but had returned to almost the preoperative level 1 month postoperatively. Mean goblet cell density (GCD) had decreased significantly at 1 day, 1 month, and 3 months postoperatively (P < .001). In addition, decrease in GCD and cataract operative time were highly correlated (r (2) = 0.65).

The decrease in GCD, which was correlated with operative time, had not recovered at 3 months after cataract surgery. Therefore, microscopic ocular surface damage during cataract surgery seems to be one of the pathogenic factors that cause ocular discomfort and dry eye syndrome after cataract surgery.

Jpn J Ophthalmol. 2012 Feb 3. [Epub ahead of print]
Oh T, Jung Y, Chang D, Kim J, Kim H.
Department of Ophthalmology and Visual Science, St. Mary's Hospital, College of Medicine, The Catholic University of Korea, #62 Yeouido-dong, Yeongdeungpo-gu, Seoul, 150-713, Korea.

Abstract: Amniotic fluid (mouse study)

Effects of topical human amniotic fluid and human serum in a mouse model of keratoconjunctivitis sicca.

To compare the effects of topical human amniotic fluid (HAF), topical human serum (HS), and topical artificial tears in a mouse model of dry eye.

Thirty C57BL/6 mice were divided into 3 treatment groups: HAF, HS, and preservative-free artificial tears. Dry eye was induced by an injection of botulinum toxin B (BTX-B) into the lacrimal gland. Tear production and ocular surface fluorescein staining were evaluated in each mouse at 6 time points during a 4-week period. Goblet cell density was assessed in stained histological sections. Apoptotic keratocytes were evaluated by terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling test assay.

A significant decrease in tear production was observed 3 days after BTX-B injection in all groups. At week 1, the HAF and HS groups had improved tear production compared with the control group (P < 0.001 and P = 0.003, respectively). HAF had a significantly improved fluorescein staining score compared with the HS (P = 0.043) and control (P = 0.007) groups at week 2. Goblet cell density was significantly decreased in the control group compared with the HAF and HS groups (P < 0.001). No difference in the amount of terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling-positive keratocytes was observed among the groups.

HAF was superior to HS and artificial tears for improving corneal staining within 2 weeks of therapy in this induced mouse model of keratoconjunctivitis sicca. Clinical studies are needed to ascertain the benefits of these therapies in patients with ocular surface disorders associated with dry eye.

Cornea. 2012 Apr;31(4):424-30.
Quinto GG, Camacho W, Castro-Combs J, Li L, Martins SA, Wittmann P, Campos M, Behrens A.
*Wilmer Ophthalmological Institute, Department of Ophthalmology, Johns Hopkins University, Baltimore, MD †Vision Institute, Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil.