Inotek Pharma updates on glaucoma drug Phase 2b trial

Inotek Pharmaceuticals has concluded first two of three stages of a double-masked, dose-ranging, randomized and multi-dose trial evaluating an eye drop, INO-8875 in patients suffering from glaucoma or ocular hypertension.

The trial was designed to investigate the tolerability, safety, efficacy and pharmacokinetics of INO-8875 delivered as an eye-drop formulation in patients with primary open-angle glaucoma or ocular hypertension.

Inotek president and CEO Paul Howes said they believe that expanding the final stage of the Phase 2b study will produce a robust data package to support preparation for late-stage clinical trials and ongoing partnering discussions.

New study explain glaucoma risks

Glaucoma is one of the leading causes of visual deterioration on the planet, affecting millions of people worldwide, though it is more prevalent among some ethnic groups.

For years, experts have attempted to determine why African-Americans have a higher risk of developing glaucoma than Caucasians, although it seems that experts in the US may have finally found out why this occurs.

Specialists at the Washington University School of Medicine in St Louis claim that oxygen levels are significantly higher in the eyes of African-American glaucoma patients than in Caucasians who have the condition.

In a report published in the July issue of the Archives of Ophthalmology, they theorise that more oxygen may lead to damage in the eye's drainage system in the eye, resulting in elevated pressure which in turn damages the optic nerve and causes blindness.

First author Dr Carla Siegfried pointed out that the report is the first clue about the link between race and risk of glaucoma, which is approximately six times more common in African-Americans than Caucasians, while blindness caused by glaucoma is 16 times more likely.

The expert explained: "Our findings suggest there may be physiologic differences in oxygen metabolism between African-Americans and Caucasians.

"In our studies, we were not looking specifically at African-Americans, but the racial difference in oxygen levels was significant, and we believe this observation deserves further study."

Siegfried, who is also professor of ophthalmology and visual sciences at Washington University, said she is not surprised that oxygen may plays a major role in the development of glaucoma, given it could be a source of 'free radicals' that damage cells.

As with eye diseases such as cataracts, glaucoma is directly associated with ageing, as is oxidative stress, which is an imbalance between these 'free radicals' and antioxidants'.

This, in turn, is linked to the ageing process and several other age-related diseases such as cardiovascular and neurodegenerative conditions, she noted.

"However, more study is required. When we understand the underlying reason for elevated oxygen and how it may damage the eye, we will be in a better position to develop ways to prevent this disease," the expert said.

New Medicare diagnosis codes apply to stages of glaucoma severity

New Medicare glaucoma diagnosis codes that address glaucoma severity based on visual fields are scheduled to be implemented on Oct. 1, an expert said at the American Glaucoma Society meeting.

Many Medicare carriers already have policies in place allowing certain numbers of visual field or optic nerve imaging tests based on the severity of the glaucoma, and many private payers are currently using claims-based data to profile and rank physicians, according to Cynthia Mattox, MD, the chair of the AGS Patient Care Committee and a member of the AAO Health Policy Committee. Having physicians assign codes that reflect the actual clinical stage of disease will allow for more accuracy in claims-based payment or profiling methodologies that are already in place or may be designed in the future, she said.

“They’re not going to adversely impact our coverage policies now, so there’s no reason to be afraid of them,” Dr. Mattox said. “All of our original glaucoma diagnoses are still in there and will link to any coverage policies that are related to testing that we want to do or procedures that we want to do. … [They’re] also going to allow for some health policy research improvements, to be able to use claims-based codes so that we can understand a little bit more about the populations that everybody is taking care of.”

New device makes glaucoma surgery safer

Glaucoma is a disease of the optic nerves wherein the nerve fibers progressively disappear causing the field of vision to become narrower and narrower until total blindness ensues.

For patients with glaucoma, it is important to keep the internal eye pressure low, otherwise the damage to the optic nerves gets worse. Usually glaucoma medications will lower eye pressure but sometimes they don’t work very well.

One example is patient ABC. He had very severe glaucoma in both eyes, and, despite four different eye drops, placed one after the other during the course of the day, the targeted eye pressure of 12 mmHg or below could not be achieved. In the right eye, pressure was 26 mmHg, and in the left 20 mmHg.

Ordinarily, a glaucoma filtering operation, where a window in created to act as a passageway of the fluid within the eye to the outside, would be recommended. The problems with the original procedure in the immediate period after surgery would be inflammation and too much exiting of the fluid. Technological improvements have made the procedure less traumatic and much safer.

A patient who benefited from the new technology is Mr. ABC. He chose to follow the recommendation of having a stainless tube-like implant placed in his eye instead. The implant called an Ex-press shunt creates a passageway for the fluid to exit the eye in a controlled manner.

His right eye was operated on first; the procedure took 35 minutes under local anesthesia. The eye was not patched and anti-inflammatory and antibiotic drops were given. His eye pressure went down to almost 10 mmHg even without any glaucoma drops. There was only mild inflammation at the site of operation, otherwise the patient was comfortable.

Mr. ABC was so relieved that he soon scheduled his left eye.

Galileo SurgiCenter believes that the Ex-press shunt which is distributed by Alcon Laboratories is a significant improvement over the traditional filtering surgery where the post-operative course would sometimes be complicated.

Glaucoma-Correction Glasses

My otherwise ridiculously healthy dad was diagnosed with glaucoma a while back, and though it now appears to be under control thanks to the right prescription meds, his vision isn't as good as it used to be. Specifically, the contrast and brightness of what he sees with that eye has been reduced.

An avid user photographer, my dad posed a fascinating solution to this problem. What if he hooked up a Looxcie-style video camera near his left eye, then fed the resulting video through an auto-contrast filter, which would display on a small screen inside a pair of glasses. It might look weird, but it'd be a real-life use of augmented reality that's actually useful. In rough visual terms, this is what the problem is and what the solution would do:

Glaucoma-Contrast.jpg

To me, the strange thing is that this sounds possible, even plausible. Then again, I don't know how technically challenging it is to provide that kind of real-time video correction. Where are the sticking points? My dad and I would love your help sketching out how this contraption could work -- and then building it.

Searching around for information on how difficult this task might be, I wasn't able to find much. Much of the discussion around augmented reality vision focuses on contact lenses, I suppose because they are futuristic and sexy. But my dad isn't looking for anything that crazy. He just wants a pair of glasses with an auto-contrasting screen for the left eye.

I found a Spanish team was working on a vision augmentation system back in 2005. They seemed to have made some progress, but that was years ago. The trail goes cold after that and I haven't really seen it.

So, how about it, hardware hackers: could you do this?

I pasted in my dad's original query below, so you can hear his specific descriptions. I'd be happy to put any interested hackers in touch with him, as long as you are not a crazy person. Or, rather, as long as you are the right kind of crazy person.

As any user of Picasa or probably any other photo manipulator program knows, there is a button, "Auto-contrast," that will sharpen and lighten up any image unless there is a large bright vs dark gradient e.g., big bright sunny sky on upper half of a composition and say, dark forest in the bottom part in the shot. Normally, if the image is within a relatively narrow range of lighting, it will light up and sharpen it as if by magic.

Well, I have observed that my left eye -- affected by advancing Glaucoma -- perhaps now being controlled by the right mix of prescription eye drops, perceives significantly less light and detail (contrast) than my almost normal right eye, with or without prescription glasses on. Probably there is no way to have a corrective prescription that would restore the ability of the optic nerve to perceive the full details of what it is seeing. However if the lenses themselves could auto-contrast the image as it goes through the lens by the application of some type of software embedded in the glasses frame along with some miniaturized hardware also embedded in the frame, the eye would be looking at the enhanced (brightened and sharpened) image in the lens providing the eyes cones and rods with enough additional light to offset some if not all the lost capacity. The lenses might have to look as Borg-like appendages to accommodate the additional technology.

IOP and primary open-angle glaucoma, pseudoexfoliation glaucoma

Study shows link between IOP and primary open-angle glaucoma, pseudoexfoliation glaucoma



IOP was the only risk factor associated with both primary open-angle glaucoma and pseudoexfoliative glaucoma, while moderate to high myopia correlated slightly with both conditions, a study found.

Vascular systemic diseases and treatments correlated solely with primary open-angle glaucoma.

“The implications of these differences for the pathogenesis between the two common types of [open-angle glaucoma] should be explored further,” the study authors said.


Data were culled from the Thessaloniki Eye Study, a cross-sectional population-based analysis of chronic eye diseases in Thessaloniki, an urban center in Northern Greece. The study included 2,554 patients age 60 years and older.

Investigators set out to assess risk factors for primary open-angle glaucoma and pseudoexfoliative glaucoma. Open-angle glaucoma patients were compared with a non-glaucomatous control group. Primary open-angle glaucoma subjects were compared with controls without pseudoexfoliation. Pseudoexfoliative glaucoma subjects were compared with controls with pseudoexfoliation for demographic, lifestyle, ophthalmic and systemic factors.

Multivariate analysis was limited to 2,078 patients who attended clinic visits and had at least one phakic eye.

Results showed that IOP (P < .001), pseudoexfoliation (P < .001), history of coronary artery bypass or vascular surgery (P = .017) and moderate to high myopia (P = .009) correlated most strongly with open-angle glaucoma.

Data from 1,840 patients with primary open-angle glaucoma showed that age (P = .048), IOP (P < .001), history of coronary bypass or vascular surgery (P = .01) and history of diabetes treated with insulin (P = .045) were strongly associated with primary open-angle glaucoma.

Among 238 patients with pseudoexfoliative glaucoma, there was a correlation with elevated IOP (P < .001), the authors reported. There was a slight association with moderate to high myopia (P = .06).

Better tracking glaucoma progression

Having more frequent visual tests could be linked with better tracing of glaucoma progression, a study finds


More frequent visual tests for glaucoma patients could allow physicians to better follow the condition's progression, a study finds.

A study released online Monday in the Archives of Ophthamology examined data on 468 eyes of 381 patients age 35 to 80 who were part of a long-term intervention study. The participants had primary open-angle glaucoma no longer being controlled by medication. This type of glaucoma is the most common form and usually hits people over 50. It causes damage to the optic nerve and usually progresses slowly, sometimes without being noticed. The researchers' goal was to see if more frequent visual field tests to check peripheral vision resulted in earlier discovery of the progression of the glaucoma.

LASIK and Glaucoma

Glaucoma has affective the vision of roughly 3 million people in the United States. Many of these people do not know they suffer from glaucoma because there are no outward symptoms until the vision has been affected. Your ophthalmologist can catch glaucoma in its early stages before it affects your vision by conducting a routine eye examination.
Information About Glaucoma
Glaucoma is an eye condition that gradually damages the optic nerve in the eye. The optic nerve is responsible for transmitting the visual information supplied by the retina directly to the brain. A damaged optic nerve can lead to permanent blindness.
A thick, watery liquid called the aqueous humor moves through the space called the anterior chamber located between the cornea and the leans of the eye. The aqueous humor supplies nutrition to the tissues of the eye, the lens, and the cornea. The aqueous humor drains from the eye through the trabecular meshwork. Internal ocular pressure (IOP) builds up in the eye when the aqueous humor does not properly drain through the trabecular meshwork.
Increase of IOP will put pressure on the optical nerve and gradually cause damage affecting your vision. The only outward sign of glaucoma is affected vision. It is often too late to save your vision by the time your vision is affected by glaucoma. Early detection and treatment will prevent permanent damage to your vision.
Treatment for glaucoma depends on the severity of the condition and can include:
- Special medicated eye drops
- Laser surgery
- Other eye surgery
LASIK and Glaucoma
You may not be a good candidate for LASIK depending on the severity and stage of your glaucoma. It is important to schedule an initial LASIK surgery consultation with your ophthalmologist for a full eye exam to determine if LASIK is the best procedure for your vision correction needs. Your ophthalmologist will be able to suggest another vision correction procedure if you are not a candidate for LASIK.
During the LASIK procedure, a flap is created in the outer portion of the cornea to allow access to the area of the cornea that needs to be reshaped to improve your vision. The flap is created using a microkeratome. A vacuum ring is used to attach the microkeratome to your eye. The vacuum ring causes suction that will temporarily increase the pressure inside your eye. Patients without glaucoma will not be affected by the suction. However, the increase in pressure can cause negative affects to patients with glaucoma.
You can become a candidate for LASIK once your glaucoma is treated and your condition is stable. There are other laser vision correction procedures that can be performed if you have glaucoma. PRK is a laser vision correction procedure that does not require the use of a microkeratome or the use of suction. It is a good idea to discuss your vision correction options with your ophthalmologist before deciding on a procedure.

Eye-rubbing may indicate glaucoma

Penny is a 10-year-old cocker spaniel who has had her share of ear problems.

Pat isn't sure whether Penny is having a problem now, but she is noticing a new behavior. Penny is rubbing the left side of her face on the carpet, and she's started to do it more frequently.

Pat thinks Penny is specifically rubbing her left eye. There is some redness around the eye and the eyeball. Pat first thought Penny may have gotten something on her face, but she no longer believes that to be the case.

Well, Pat, there is a problem. That's the easy part. Determining the underlying problem is the not-so-easy part.

I am going to assume that Penny is indeed rubbing her eye and not some other area close to it. So we can conclude there must be something irritating Penny's left eye or the lids around it.

There are many possibilities that can cause eye irritation. Penny may have damaged the corneal layer of the eye, causing significant discomfort. The cornea is a very specialized layer of clear cells that covers the colored portion of the eye, the iris. The pupil is behind the cornea. Damage to the cornea can come from contact with anything that can score or puncture the tissue. Foreign material in the eye is but one possibility.

Penny may have developed a conjunctivitis or inflammation of the conjunctiva. The conjunctiva is a very thin layer of tissue that covers the inside of the eyelids and eyeball itself. It can become inflamed from an allergic response or a bacterial infection or a combination of both. This list can go on, but there is one possible cause that is potentially very serious and could lead to blindness. Cocker spaniels are a high-incidence breed for this disease.

Penny may have glaucoma. Glaucoma occurs because of increased pressure within the eye. The eye is actually filled with a viscous fluid that supports its round structure. The fluid is maintained at a constant pressure through constant production within the eye and constant drainage out of the eye. If this system is disturbed, usually affecting the drainage, the pressure within the eye can increase; if left untreated, this increased pressure will destroy the retina at the back of the eye, causing blindness.

This process can be extremely painful and is considered an emergency.

In humans with acute glaucoma, the increase in pressure and corresponding discomfort can be communicated to the doctor and therapy immediately performed. Pets do not usually do this, at least early on, although Penny may have done so with her rubbing behavior.

Penny needs immediate veterinary attention. If she does have glaucoma and there is still sight present, we may be able to save her eye. If not, she will need to have treatment done to alleviate her pain. This might include removal of her nonfunctioning eye.

New gold standard in glaucoma treatment

The price of gold is going up but a clinical trial shows it may be worth it for some people with vision problems. Yale glaucoma surgeon Nils Loewen checks on his patient Ron Kortsep.

Ron recently had one of these inserted into his eye. It's called a "shunt made of gold." It's to prevent glaucoma from stealing his eyesight.

"My left eye was getting weaker, I was losing vision, peripheral vision which glaucoma tends to do, the glaucoma was getting more aggressive so we're trying some different things to bring the pressure down," Kortsep said.

Losing his eyesight would be devastating for Kortsep, who loves to travel the world and see the sights. Dr. Loewen is the first physician in the U.S. to insert a gold shunt into a patient's eye. It's part of a trial. The device reduces eye pressure by helping it drain properly.

"It all happens at the front part of the eye where the big surgeries with the drainage implants are at the very back, even back past the equator in some cases," Loewen said.

The procedure is already approved in other countries. In one picture you can make out the tiny shunt at the bottom of the eye. The shunt is made of gold and gold is really expensive, so you must be thinking these must be costly. They're actually only worth pennies apiece, but they do cost a lot because of the price of research and development to create them.

So you may be wondering why gold? It isn't like a bar of gold, it's highly purified. Scientists take out all of the copper and the body does not reject it. Dr. Loewen said this shunt could become the gold standard if approved for glaucoma patients, because results are promising and it's less invasive.

"With these smaller incisions less wound area, equals a quiet eye, equals a comfortable eye," Loewen said.