Friday, October 30, 2015

Coming soon to an ECP near you: Cheaper Lipiflow?

Seems probable...

TearScience® Announces New Pricing Strategy For Core LipiFlow®Technology Used For Treatment Of Dry Eye From Meibomian Gland Disease (MGD)


MORRISVILLE, N.C.--10/28/15 - ()--TearScience, a privately held medical device company, has announced a 50% price cut, effective immediately, on the single-use activators used with the LipiFlow treatment platform for Meibomian Gland Disease (MGD). The move is just one component of an overall strategy to make the LipiFlow and LipiView® Technologies more accessible to Eye Care Professionals (ECPs), who can then, in turn, use them to evaluate and intervene earlier in MGD for the benefit of the millions of individuals suffering from this chronic and progressive obstructive gland disease.

After recent unprecedented growth in use of its LipiFlow technology, TearScience is achieving the economies of scale necessary to reorganize and expand its supply and manufacturing capabilities. Furthermore, TearScience brought on board a new management team with a renewed mission to meet a market need of technology and treatment accessibility. Earlier this year, TearScience lowered the price of its technologies and removed imaging fees....

Wednesday, October 28, 2015

Way to save money on eyedrops?

SimplyTouch eyedrop applicator...

$12.50 is awfully steep for a little bitty thing. On the other hand, if you're spending $300 a month on Restasis, it could pay for itself on the very first use....


Better symptom results from latest study of Shire's Lifitegrast dry eye drug

Shire will be resubmitting its application to the FDA early next year on the strength of these improved results.

Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints, Significantly Reducing Patient-Reported Symptoms for Dry Eye Disease


...."The results from OPUS-3, where lifitegrast demonstrated symptom improvement as early as two weeks, provide compelling efficacy data that contribute to the totality of evidence from the lifitegrast clinical development program, now the largest for an investigational stage compound in dry eye disease with more than 2,500 patients," said Philip J. Vickers, Ph.D., Head of Research & Development, Shire. "We believe the data from OPUS-3 will satisfy the FDA's request for an additional clinical study. We welcome the opportunity to share these positive data with the regulatory authorities."

Recent study: TBUT lower in women with PCOS

Eur Rev Med Pharmacol Sci. 2015 Oct;19(19):3556-62.

Abstract

OBJECTIVE:

Complaints of dry eye are prevalent worldwide and are known to be associated with insulin resistance (IR) and hyperandrogenism. However, dry eye is often overlooked in the context of polycystic ovary syndrome (PCOS). The aim of the present study was to evaluate whether or not there is any relation between tear functions and PCOS, which is a multifaceted disorder associated with IR or hyperandrogenism.

PATIENTS AND METHODS:

A total of 35 women with polycystic ovary syndrome (PCOS) were enrolled in this study, along with 27 healthy controls. Body mass index (BMI), follicle-stimulating hormone (FSH), luteinizing hormone (LH) and free testosterone levels on the third day of menstruation were recorded, as well as hirsutism score (using the Ferriman Gallwey scoring system), insulin resistance (homeostasis model assessment), neutrophil-to- lymphocyte ratios (NLR), platelet-to-lymphocyte ratios (PLR), and mean platelet volumes (MPV). A complete ocular examination was followed by administration of the ocular surface disease index (OSDI) questionnaire and Schirmer and tear break-up time (TBUT) tests.

RESULTS:

Schirmer and OSDI results were similar between groups, but TBUT was significantly lower in the PCOS group (p = 0.002). There were negative correlations between FG score and TBUT test (r = -0.406, p = 0.001) and between NLR and Schirmer test (r = -0.294, p = 0.025).

CONCLUSIONS:


Although subjective dry eye symptoms do not present in all patients, these results confirm that tear reduction, which can cause further complications in patients with PCOS, can be detected by careful examination and sensitive tests.

PuriLens Plus in place of Unisol 4

Just a quick update to my last - 

There is a product that is apparently identical to the quickly-disappearing Unisol 4: 

PuriLens Plus. 
Sold in a 4 oz bottle. 
$2.95 to $3.95 depending on quantity.

Tuesday, October 6, 2015

Unisol 4 being discontinued

Alert for PROSE & scleral lens users who use Unisol 4 to fill their lenses:

I had been getting reports from customers that Unisol 4 is getting scarce or has been discontinued. I called Alcon today to get the skinny. They said yes, it is being discontinued, officially as of December this year and at this time they have no plans for a replacement.

Obviously it's already disappearing from shelves. Those who use it... it's definitely time to stock up unless you have an acceptable alternative that you already know of.

I have a couple of alternatives in the DryEyeShop - Addipaks (5mL), and Modudose (5mL and 15mL) which I sell in small quantities for people to try. If you need a Unisol replacement though be sure to check with your eye doctor first.

Thursday, August 27, 2015

Ointment recall alert: Refresh PM, Lacri-Lube, FML, Blephamide



FOR IMMEDIATE RELEASE - Dublin, Ireland – August 24, 2015 – Allergan plc, today announced that it is conducting a voluntary recall down to consumer level of specific lots of its REFRESH® Lacri-Lube® 3.5g and 7g for dry eye, REFRESH P.M.® 3.5g for dry eye, FML® (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g.
Allergan chose to initiate this recall based on a small number of customer complaints which reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product. Reported adverse events include Foreign Body in Eye (12), Eye Irritation (2), Ocular Discomfort (2), Product Contamination (2), Superficial Injury of Eye (2), Eye Pain (1), Eye Swelling (1) and Vision Blurred (1).
Specific lots are being voluntarily recalled in the interest of patient safety. If the particle gets into the eye, potential adverse events may include eye pain, eye swelling, ocular discomfort or eye irritation. Please contact your physician or healthcare provider if you have any of these symptoms when using these products. The lot number and expiration date may be found on the bottom flap of the carton with the safety seal and on the crimp seal of the product tube.
Specific information on product and lots that are being voluntarily recalled are below:
NDCDescriptionLot NumberExpiration Date
0023-0312-04REFRESH® Lacri-Lube® 3.5 g84746 Apr-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g84987May-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85087May-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85359Jun-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g85721Jul-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86045Aug-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86406Sep-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g86594Oct-17
0023-0312-04REFRESH® Lacri-Lube® 3.5 g87021Nov-17
0023-0312-07REFRESH® Lacri-Lube® 7g86470Sep-17
0023-0312-07REFRESH® Lacri-Lube® 7g86829Oct-17
0023-0312-07REFRESH® Lacri-Lube® 7g87105Nov-17
0023-0240-04REFRESH P.M.® 3.5 g85165May-17
0023-0240-04REFRESH P.M.® 3.5 g85228May-17
0023-0240-04REFRESH P.M.® 3.5 g85244Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85351Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85374Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85397Jun-17
0023-0240-04REFRESH P.M.® 3.5 g85561Jul-17
0023-0240-04REFRESH P.M.® 3.5 g85676Jul-17
0023-0240-04REFRESH P.M.® 3.5 g85694Jul-17
0023-0240-04REFRESH P.M.® 3.5 g85834Aug-17
0023-0240-04REFRESH P.M.® 3.5 g85977Aug-17
0023-0240-04REFRESH P.M.® 3.5 g85985Aug-17
0023-0240-04REFRESH P.M.® 3.5 g86073Aug-17
0023-0240-04REFRESH P.M.® 3.5 g85599Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86290Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86325Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86411Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86427Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86506Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86515Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86517Sep-17
0023-0240-04REFRESH P.M.® 3.5 g86746Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86792Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86789Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86809Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86822Oct-17
0023-0240-04REFRESH P.M.® 3.5 g86822AOct-17
0023-0240-04REFRESH P.M.® 3.5 g86932Nov-17
0023-0240-04REFRESH P.M.® 3.5 g87100Nov-17
0023-0240-04REFRESH P.M.® 3.5 g87068Nov-17
0023-0240-04REFRESH P.M.® 3.5 g87156Dec-17
0023-0240-04REFRESH P.M.® 3.5 g87261Dec-17
0023-0240-04REFRESH P.M.® 3.5 g87493Jan-18
0023-0240-04REFRESH P.M.® 3.5 g87494Feb-18
0023-0240-04REFRESH P.M.® 3.5 g87731Feb-18
0023-0240-04REFRESH P.M.® 3.5 g (Professional Sample Pack)85165May-17
0023-0240-04REFRESH P.M.® 3.5 g (Professional Sample Pack)86789Oct-17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g
 
86258Sep-17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g
 
87189Dec-17
0023-0316-04FML® (fluorometholone ophthalmic ointment) 0.1%, 3.5 g
 
87514Feb-18
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g86430Sep-17
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g87806Feb-18
0023-0313-04Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, 3.5 g88147Mar-18
Allergan has informed the U.S. Food and Drug Administration of this voluntary recall. The recall only applies to specific lots of the REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® (fluorometholone ophthalmic ointment) 0.1%, Blephamide® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2%. This recall does not affect any other REFRESH or Allergan product.
Allergan is contacting retailers and wholesalers who have been shipped affected product lots to initiate the recall and is informing them of the steps needed to return affected product.
The company is asking consumers who currently have product from any of the affected lots of REFRESH® Lacri-Lube®, REFRESH P.M. ®, FML® (fluorometholone ophthalmic ointment) 0.1% , Blephamide® (sulfacetamide sodium or prednisolone acetate ophthalmic ointment, USP) 10%/0.2%, to stop using the product and return it to Allergan.
If there are questions or if assistance is required in response to this recall, please use the contact information below.
CONTACT INFORMATION  
Product Returns
Contact GENCO at:
877-674-2087
7 am to 5 pm CST
Credit/Reimbursements
Contact Allergan at:
1-800-811-4148
7am to 5pm PST
Allergan
Medical Inquiries
:

1-800-433-8871 option 2 8am - 5pm PST

Adverse Events/Products Complaints:

1-800-624-4261 Option 3 (8am - 5pm CST)
FDA contact information for reporting adverse events/quality complaints:
Online at www.fda.gov/medwatch/report.htm or call FDA at 1-800-FDA-1088