I have just written and placed online, a major study on the use of stem cells in ophthalmology.

It is a comprehensive look at the different types of stem cells, the eye diseases they may be able treat, and the companies involved in developing commercial stell cell-based treatments and therapies.

Briefly, stem cells are like blank slates that can develop or “differentiate” into specialized cells that carry out a specific function, such as in the skin, muscle, liver, or in the eye. Stem cells have application for diseases in the front of the eye, the middle of the eye, and the back of the eye.

In the front of the eye, scarred and degenerative corneas represent one prime area of research for the use of stem cells. Because of a lack of donated human cornea bank corneas for transplantation, especially in populous nations such as India and China (and the third World countries), the use of stem cells to regenerate damaged corneal tissues could become lifesavers in those countries where blindness due to damaged corneas is prevalent.

There are only a few research programs using stem cells for the middle areas of the eye, specifically in treating glaucoma. NeoStem has said that they are working with Schepens Research Institute in using the company’s VSELs (very small embryonic-like stem cells) in the treatment of glaucoma (and AMD), and Stemedica claims to be working with the Fyodorov Eye Institute in Moscow on a glaucoma program. I know of no programs targeting the lens.

Most of the research efforts appear to be focused on the back of the eye, specifically retinal tissue and diseases. Areas of interest that I have identified include regeneration of retinal epithelial (RPE) cells for the treatment of both dry and wet forms of age-related macular degeneration (AMD); replacement of damaged photoreceptors; the growth of artificial retinas, again for treating AMD; and direct treatments for diseases such as retinitus pigmentosa (RP), retinopathy of prematurity (ROP), diabetic retinopathy (DR), Stargardts disease (Stargardt Macular Dystrophy) (SMD), and retinal veinr occlusions (RVO).

The study also includes detailed information about the six companies that I’ve identified as active in this field, and includes a brief history of the use of stem cells in ophthalmology:

• Advanced Cell Technology Incorporated
• International Stem Cell Corporation
• NeoStem Incorporated
• Pfizer Regenerative Medicine
• Pfizer Ophthalmics
• StemCells Incorporated
• Stemedica

Here is the link to the full study.

I recently wrote an extensive article about Illuvien and the future of ophthalmic drug delivery systems.

Illuvien is a new hope in the treatment of diabetic macular edema (DME). Illuvien delivers fluocinolone acetonide (FA), a corticosteroid, to the retina for up to three years, thus forgoing the need for multiple drug injections and/or laser treatments to alleviate the symptoms.

Well, Alimera, the company behind Illuvien, received good news yesterday in the form of notification from the FDA that its NDA (new drug application) for Iluvien had been accepted for filing and granted Priority Review status. FDA Priority Review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 months to six months.

With priority review, Alimera could receive a response from the FDA in the fourth quarter regarding its NDA for Iluvien, which was submitted at the end of June 2010.

This is exciting news for patients, and will provide an alternative to laser, frequent injections and off-label treatments currently available for DME.

Here is a link to the full article.

I have just written and placed online an in-depth writeup about a new drug delivery system, that should obtain FDA marketing approval by the end of this year. It has the potential to treat diabetic macular edema for up to three years.

The drug system is called Iluvien and is from Alimera Sciences.  Iluvien is a tiny, extended release intravitreal insert (the size of a grain of rice), that provides a method to deliver fluocinolone acetonide (FA), a corticosteroid, to the retina for up to three years for treatment for diabetic macular edema (DME). It is one a group of new ophthalmic sustained drug delivery systems that are currently on or about to enter the market for treating ophthalmic diseases, especially in the retina.

In addition to the story of Iluvien, I have listed a group of sustained drug delivery system under development for various other ophthalmic diseases.

Here is the link to my writeup: http://tinyurl.com/Iluvien

Irv Arons

I recently had a patient come into my practice (I am a board certified optician in FL) who had inexplicably lost vision bilaterally. It seems that the man’s optic nerve ‘canal’ (his word) had swollen, shutting off blood flow to the eye. This first happened to the right eye, eventually leaving him with virtually no vision (finger count). He then suffered the same issue in the other eye, but has retained 20/60- in that eye. He has been to several “specialists” who have not yet either A) given him a specific root cause (hypertension, diabetes, and a couple other possibilities have been mentioned) and B) he’s been told there really is no help for this, that he could have this happen again, and could lose all vision. So, I came here, as I read this site quite often. Has any one seen this? And/or, the patient and family are talking about ’stem cells’ and even mentioned the chip technology, but I”m not sure that would have any real efficacy in this case. Any responses would be much appreciated.

Clinics all over the world offer stem cell treatments for a wide variety of conditions, and there has been a substantial amount of discussion on this blog concerning use of stem cells to treat various retinal conditions. Consumers will therefore be happy to learn of a new website launched by the International Society for Stem Cell Research (ISSCR) to provide resources to patients and their families seeking to evaluate the claims of providers of stem cell treatments.

The site was launched in response to increased advertising touting expensive stem cell therapies that play on patients’ hopes and fears, and often make exaggerated claims of efficacy, underestimate potential risks, fail to disclose methods, and leave out information on whether the treatment is conducted with regulatory oversight.

For starters, we recommend reading the top 10 things to know about stem cell treatments, which aims to correct some of the misinformation that is being widely circulated about stem cell treatments.

There’s also a patient handbook on stem cell therapies. Among other things, the handbook contains questions for patients to ask a stem cell treatment clinic.

Longer term, the site will feature lists of clinics and other service providers that claim to offer stem cell treatments. The lists will tell you whether the clinics do or do not provide the ISSCR with evidence that appropriate oversight and other patient protections are in place for the treatments they offer. If patients hear about a clinic, they can submit that clinic for review by the ISSCR.

Here are some updated results on the Ellex 2RT pilot studies being undertaken in Australia, that were first reported at this Spring’s ARVO Meeting. I was provided with three month results of a study using 2RT for treating proliferative diabetic retinopathy and six-month results on a study of treatment for early AMD. The results in both cases are promising.

The link for the 2RT results is found here.

I am a 48 yr old male with diabetes, high blood pressure, sleep apnea and a central vein occlusion. My doctor gave me Avastin shots every 3 weeks and it helps my vision. Although when i wake up in the mornings i am almost blind and it gets better throughout the day. By about noon, I can see very well. Any  ideas to improve my situation?

I have non-arteritic anterior ischemic optic neuropathy (NAION) due to an ulcer that bled and dropped by hemoglobin and my blood pressure dropped. I have high cholesterol and high Triglycerides and border line to diabetes. I am legally blind. Can stem cell treatment help restore the optic nerve?

A small, but popular study published in the January issue of Ophthalmology finds no correlation between serum levels of Vitamin E and “inconsistent” results for Vitamin C and magnesium.  The conclusions are based upon a meta-analysis of over 4100 patients.

Laboratory evidence, however, indicated possible associations between the antioxidants and magnesium.  For instance;

• Vitamins C and E suppress production of VEGF
• Monocyte adhesion to retinal endothelial cells caused by hyperglycemia is inhibited by Vitamins C and E
• Impaired insulin action and glucose uptake caused by altered protein kinase C may be reveresed with Vitamin C
• Magnesium acts as a calcium antagonist

Based on these laboratory findings, no association between diabetic retinopathy and Vitamin E, Vitamin C and magnesium could be established.  Several conflicting results regarding Vitamin C and magnesium levels warrant further investigation the authors noted.

Randall V. Wong, M.D.
Retina Specialist
Fairfax Virginia

pSivida Corp., a sustained release drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back of the eye diseases, recently reported top-line 24 month results from the Phase III FAME™ study of Iluvien® for the treatment of Diabetic Macular Edema (DME) being conducted by pSivida’s collaborative partner Alimera Sciences.

More patients receiving either the High Dose or Low Dose Iluvien showed improvement in best corrected visual acuity of 15 or more letters at 2 years compared to those receiving sham treatment.

pSivida’s licensee, Alimera Sciences, plans to file New Drug Application (NDA) in the second quarter of 2010.

Read the full press release.