Thursday, May 5, 2011

Akorn to acquire AVR (Theratears Co)

Answering the question of the next step for Dr. Jeffrey Gilbard's legacy company, Advanced Vision Research, Akorn is stepping up to the plate to purchase the maker of TheraTears.

Akorn buying Advanced Vision for $26 mln cash
May 3, 2011


Akorn Inc. AKRX +2.44% said it will buy Massachusetts ophthalmic company Advanced Vision Research Inc. for $26 million.

With the deal, the niche generic pharmaceutical company that makes ophthalmic and injectable pharmaceuticals said it plans to launch a new consumer-health division to enter the over-the-counter eye-care market, pending the acquisition of the company.

Akorn said it expects the deal will be neutral to its 2011 per-share earnings, and it said it expects the deal to help 2012 earnings by 3 cents to 4 cents a share.

Advanced Vision develops products used for dry eyes, eyelid hygiene, contact lens comfort and eye nutrition under the TheraTears and MacuTrition brand names. The company had sales of $20 million last year across 20 countries.

Akorn Chief Executive Raj Rai noted that "AVR is a great strategic platform to expand into the OTC eye care market," and he said Akorn has had a "positive relationship with AVR for several years as a primary contract manufacturer."

Shares of Akorn closed Monday at $6.54 and were inactive premarket. The stock has more than tripled in value in the past year.

New product: Alpha Eye Mask


A long-time dry eye patient came up with her own solution to night dry eye and has done a nice job bringing it successfully to market. For details see www.alphaeyemask.com.

Dry Eye Relief in Sight as 'The Alpha Eye' Dry Eye Mask Now Available from Drugstore.com, DreamEssentials.com and Toolsforwellness.com


Santa Cruz-Watsonville, CA (1888PressRelease) May 01, 2011 - Today, Watsonville-based brand builders Mackeonis & Associates announced that 'The Alpha Eye' dry eye mask from Dream Essentials will soon be available at Drugstore.com and Tools for Wellness, which will give long-needed relief to dry eye sufferers. This revolutionary system restores vital eye moisture comfortably and effectively, while sleeping or resting, and eliminates the 'sandy' feeling that most people with dry eye experience and actually improves eye health.

Studies show that approximately 60 million people in the US suffer from dry eye. Aging is the number one contributor to dry eyes, as tear ducts prove to be less productive with age, but there are other causes as well. Contact lens use, computer work, smoking, air travel, low humidity environments, Lasik and other refractive surgeries, allergies, pharmaceutical drugs and various medical conditions, including diabetes can, all bring about dry eye. 'The Alpha Eye' dry eye system is more effective at treating dry eye than just using 'stand-alone' eye drops.

Alpha Ulm, inventor of the patented 'The Alpha Eye' system and long time dry eye sufferer comments, "… It's my best 'friend.' I can't imagine living without it. It's always at my bedside. I take it on trips and wherever I go… I have become very accustomed to wearing it EVERY night. It works for me and it can work for you, too! She continues, "Relief can be felt for hours."

'The Alpha Eye' dry eye mask is soft and flexible and designed with an inner pocket that holds a special disposable liner, which slows down evaporation of natural tears and favorite eye drops, by forming an effective barrier. The liner rests gently over both eyes creating a moist environment around the eyes, while moisturizing the delicate skin around them. The inner liner can also be spritzed with distilled water to add extra moisture to the eyes. 'The Alpha Eye' is easy to use and can be applied for short periods during the day, or all night, so the eyes feel fresh and moist the next day. While hydrating the eyes, it also doubles as a black-out mask.

'The Alpha Eye' retails for $39.95 and includes the exclusive dry eye mask, 30 liners, a spritzer bottle for distilled water and a detailed instruction booklet. The optional liners can be purchased separately at $ 4.95 for 30. For more info about 'The Alpha Eye' dry eye mask go to www.alphaeyemask.com or www.dreamessentials.com .

Contacts:

Dream Essentials: mark[at]dreamessentials.com
Mackeonis & Associates: lisa[at]mackeonis.com
Alpha Ulm: alpha[at]alphaeyemask.com

http://www.mackeonis.com

Dry eye goggles... but for diagnostic purposes

Hmph. When I read about this I was kind of wishing I had a pair of them to wear right now - with humidity set to 40%. Wouldn't mind being told what my blink rate is, either.

Yes! A dry eye in the house
25/04/2011

Rice bioengineering students' invention may help diagnose painful condition

Rice University bioengineering students responded to an ophthalmologist's cry for help with a device to diagnose dry eye, the itching and burning sensation that results when a person doesn't produce enough tears or the tears evaporate too quickly.

A team of five seniors made a portable unit that controls the air around a patient's eyes so doctors can study and treat those who suffer from this painful condition.

Stephen Pflugfelder, the James and Margaret Elkins Chair and professor of ophthalmology at Baylor College of Medicine's Cullen Eye Institute, approached Rice to invent a device to help clinicians standardize a testing regime for dry eye.

"He wanted a way to control temperature, humidity and air flow all around the eyes and record it over time so he could track changes in their dryness," said Daniel Hays, a member of Team ClimaTears, the student group that included Austin Edwards, Amanda Shih, Anastasia Alex and Michelle Kerkstra.

The students' solution incorporates a modified and padded set of laboratory goggles with embedded data sensors that monitor temperature, relative humidity, air flow and blink rate over an hour and a half. A cable carries data saved every 10 seconds to a small box that includes controls and conditioning equipment. A separate hose carries air to the goggles.

The goggles keep the humidity of air around the eyes between 40 and 15 percent -- "about as low as we can go without hurting patients," Alex said.

"We're exacerbating the symptoms so doctors can see them," Hays explained.

Normal patients will produce tears, he said, but those who suffer dry eye will exhibit symptoms, which will give clues about how to treat them. Follow-up sessions with the goggles will let doctors see how well the treatment is working.

"With this, we're putting the power in the hands of clinicians, which is very appealing to them," Shih said.

"We did a lot of research on the ocular test they currently perform to help us analyze the data we collected," Alex said. "We know there's still a lot to be done."

"We hope our device will create a gold standard for diagnosis," Kerkstra said.

The team and Pflugfelder spent two weeks this spring testing patients at the Alkek Eye Center in Houston and will continue this summer. The students hope the larger trial will lead to an academic paper -- a fine reward for spending nearly 2,000 hours developing the goggles over the course of their final year at Rice.

Their work has already paid dividends. The students won the grand prize, $1,500, in the second annual Rice Alliance-George R. Brown School of Engineering Senior Design Elevator Pitch Competition last November, and more recently $500 for the Best Health-Related Engineering Design Project at the School of Engineering Design Showcase held April 14.

The team's faculty advisers were Renata Ramos, a Rice lecturer in bioengineering, and Maria Oden, professor in the practice of engineering education and director of Rice's Oshman Engineering Design Kitchen, where the goggles were developed.

Diagnostics news: SERI and the TripleTOF 5600 System

SERI selects AB SCIEX TripleTOF 5600 system to test chronic eye inflammations
April 20, 2011
AB SCIEX, a global leader in life science analytical technologies, today announced that the Singapore Eye Research Institute (SERI), an internationally known eye research center, will advance biomarker candidates it identified for chronic inflammatory eye conditions into large-scale clinical trials for validation with the AB SCIEX TripleTOF™ 5600 System. SERI plans to use the data from the TripleTOF™ system to accelerate the process to develop a clinical test to significantly improve understanding of inflammation of the eye. This information is expected to be invaluable in helping SERI develop methods with measurable end-points for improved diagnosis and pharmacological treatments of dry eye and other eye conditions that affect millions of people across the world.

Objective clinical tests to accurately measure the severity of dry eye syndrome and preclinical evaluation of new pharmacological therapies currently do not exist. As a leader in ocular proteomics studies, SERI is advancing eye research by identifying and verifying six biomarker candidates that are associated with dry eye syndrome. The institute is collaborating with Allergan, an ocular pharmaceutical company, to conduct a clinical trial with hundreds of patient samples to validate early data that these biomarkers show an accuracy rate close to 100 percent whether a person has dry eye.

SERI selected the AB SCIEX TripleTOF™ 5600 System for this important research because of the system's high throughput and high sensitivity coupled with high resolution and accurate mass. SERI is also using the Eksigent nanoLC-Ultra and cHiPLC-nanoflex chromatography technology to increase productivity and improve reproducibility. The researchers can utilize these technologies to generate better quality information from samples more easily than previously possible. With the TripleTOF™ system, SERI is expecting to complete the clinical trials in less than half the time it would take using other systems to collect research data.

Determining how the delicate epithelial cells on the surface of the cornea are affected by contact lenses is also not as well-understood as it could be, so the TripleTOF™ 5600 System, which provides high-performance quantitative and qualitative analysis with accurate mass, will be used for advanced metabolic research studies of contact lens wear. By studying the metabolomics of contact lens wear, the SERI researchers will be able to better understand how the cells on the surface of the cornea are affected by the type of lens as well as the length of time wearing the lens....

Abstract: OSD in glaucoma patients

This abstract is from a study in which the authors reviewed the published literature (including recent studies) pertaining to dry eye in glaucoma and ocular hypertension patients. The coincidence of dry eye and glaucoma is stunningly high (up to 60%). Add that to the well established fact of BAK toxicity and it just amazes me that every week, I can talk to yet another dry eye patient with glaucoma whose doctor never made any attempt to get them a BAK-free glaucoma drug. Come on, guys, surely we can do better than this!

Ocular surface disease in patients with ocular hypertension and glaucoma.

Purpose:
To review the prevalence, diagnosis, causes, and treatment of ocular surface disease (OSD) in patients with ocular hypertension or primary open-angle glaucoma.

Methods: A review of the literature pertaining to OSD and glaucoma.

Results: Recent studies indicate that OSD demonstrates an overall prevalence in glaucoma of 42% (range 20-59%) and is severe in 36% (range 14-66%). Further, the prevalence appears to increase with the greater the number of glaucoma drugs prescribed. Symptoms and signs are non-specific to the anterior surface of the eye and are thought to result from allergic, toxic, or pro-inflammatory conditions. However, the specific causes remain incompletely described, but may result from the benzalkonium chloride (BAK) preservative or occasionally the ocular hypotensive active molecule itself. Additionally, anterior segment ocular diseases might be causative, such as allergy, blepharitis, dry eye, and eyelid anatomical abnormalities. Treatment may consist of using preservative-free or non-BAK preserved glaucoma medications. Also, although unproven specifically in glaucoma patients, treatment of associated diseases of the anterior surface might reduce signs and symptoms.

Conclusions: OSD is common in treated glaucoma patients causing symptoms and signs that may impact on a patient's quality of life. Treatment is directed towards any underlying disease process and the use of preservative-free or non-BAK-preserved glaucoma preparations.

Curr Eye Res. 2011 May;36(5):391-8.
Stewart WC, Stewart JA, Nelson LA.
Source
PRN Pharmaceutical Research Network, LLC, Charleston, South Carolina, USA.