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.