Ohr Pharmaceutical Announces Clinical Squalamine Eye Drop Program for Wet-AMD

Ohr Pharmaceutical Inc. OHRP -2.91%announced today that it is advancing its clinical Wet Age-related Macular Degeneration (“Wet-AMD”) program with a novel topical formulation. Using its proprietary technology, Ohr reformulated Squalamine for ophthalmic indications from an intravenous infusion (“IV”) to a topical eye drop. The topical formulation is designed for enhanced uptake to the back of the eye and decreased potential for side effects. The previous IV formulation had been awarded fast track status and a Special Protocol Assessment (“SPA”) by the U.S. Food and Drug Administration for a Phase III registration study in patients with Wet-AMD.

Lucentis requires monthly injections directly into the eye; Squalamine delivered topically can be conveniently self-administered by the patient on a daily basis

Lucentis has the propensity for side effects and potential inherent complications of an intravitreal injection; Squalamine has shown a good safety profile even when administered systemically in significantly higher doses

http://www.marketwatch.com/story/ohr-pharmaceutical-announces-clinical-squalamine-eye-drop-program-for-wet-amd-2011-06-21?reflink=MW_news_stmp

 

Macular Degeneration: Top 5 Symptoms

The macula, which is located in the central region of the retina behind the eye, is responsible for clear vision. It is needed to discern colors, notice contrast, read, write, and appreciate fine details. Macular degeneration is the ineffective functioning of the macula. This disorder can be caused by either broken blood vessels that increase fluids in the eye or dried and degenerated cells in the eye.

There are two kinds of macular degeneration: wet and dry. When abnormal blood vessels develop behind the macula, wet macular degeneration occurs. For dry macular degeneration to occur, the macular cells degenerate and break, causing macular function disturbance.

Macular degeneration symptoms include:

• Seeing distorted images.
• Blurred vision due to an inability to identify contrast
• Diminished ability to identify the intensity of colors
• Fluid or blood in the eye
• Yellow deposits in the retina

Macular degeneration can be diagnosed based on a visual acuity test. This measures the eyes’ sensitivity to distances. Another test, tonometry, measures the pressure in the eye. The physician also preforms a dilated eye exam where the retina and optic nerves are examined for symptoms of macular degeneration.

An effective test for macular degeneration is the Amsler Grid, a macular degeneration symptoms grid. This grid is like a checkerboard with a black dot. A person with age related macular degeneration will see a distorted grid and a broader black spot.

Symptoms of wet AMD can be treated with photodynamic therapy or laser surgery. In photodynamic therapy, a drug is injected into the arm. It travels to the eye and sticks to the swollen or leaky blood vessels. The eye is then exposed to light of a certain wavelength. This process drains out excess fluid and restores vision. Continued medication can prevent reformation of wet AMD.

Dry AMD can be treated only if detected in early stages. In advanced or intermediate stages, AREDS drugs can be used to prevent worsening of the condition. AREDS drugs are a combination of high doses of zinc, copper, vitamins, beta carotene, and vitamin C.

It may be possible to prevent macular degeneration by avoiding fatty foods, eating a healthy diet rich in leafy vegetables, whole grains, dairy products, fish and meat, and drinking plenty of water. Maintaining a healthy weight and strong immunity and not smoking may also help prevent age related macular degeneration.

Read more on Newsmax.com: Macular Degeneration: Top 5 Symptoms

http://www.newsmax.com/FastFeatures/macular-degeneration-symptoms-macular/2011/03/04/id/370899

 

Bayer and Regeneron Say VEGF Trap-Eye Improves Treatment of Wet AMD

Bayer HealthCare and Regeneron Pharmaceuticals say that two Phase III studies testing VEGF Trap-Eye (aflibercept ophthalmic solution) in wet age-related macular degeneration (AMD) met the primary endpoint of statistical noninferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab (Lucentis).

The goal of these studies was to demonstrate that VEGF Trap-Eye could improve vision and maintain this improvement over time with a more convenient every-other-month dose. Patients receiving VEGF Trap-Eye 2 mg monthly achieved a statistically significant greater mean improvement in visual acuity at week 52 versus baseline (secondary endpoint) compared to ranibizumab (Lucentis) 0.5 mg monthly.

Further results will be presented at the Angiogenesis Conference in February 2011. Bayer and Regeneron are planning to submit regulatory applications in Europe and the U.S. in the first half of 2011 based on the positive results of these two trials.

http://www.genengnews.com/gen-news-highlights/bayer-and-regeneron-say-vegf-trap-eye-improves-treatment-of-wet-amd/81244280/

http://www.winknews.com/Local-Florida/2011-01-21/New-Macular-Degeneration-study-helps-Fort-Myers-woman-see

Retinal Disease Treatments for Elders Doubled Over 10 Years

MONDAY, Oct. 11, 2010 (HealthDay News) — The number of older Americans undergoing treatment for retinal conditions such as age-related macular degeneration (AMD) and diabetic retinopathy nearly doubled between 1997 and 2007, with a significant shift in the types of procedures being performed, a new study has found.

The largest increase in volume was seen in treatments for neovascular, or “wet,” AMD. New treatments for this condition include intravitreal therapy — drug injections directly into the eye — of antibodies that block the formation of new blood vessels. Between 1997 and 2001, fewer than 5,000 such injections were performed each year, but rates more than doubled each year through 2006. In 2007, there were 812,413 such injections, the study authors noted in a news release from the journal’s publisher.

The use of photodynamic therapy — a laser treatment for neovascular AMD — peaked at 133,565 procedures in 2004 and then decreased 83 percent to 22,675 procedures in 2007. Laser treatment of potentially cancerous eye tumors and the “wet” form of AMD decreased from a peak of 82,089 in 1999 to 13,821 in 2007 (another 83 percent decrease), the researchers found.

Among the other findings:

• Use of vitrectomy — surgery to remove the gel inside the eye in order to treat retinal detachment — increased 72 percent between 1997 and 2007.
• The use of scleral buckling — placement of a silicon buckle around the eye — to treat retinal detachment decreased 69 percent between 1997 and 2007.

http://www.medicinenet.com/script/main/art.asp?articlekey=120747

 

 

Potential Treatments for Macular Degeneration

Many potential treatments for macular degeneration are being investigated in laboratories and tested in human clinical trials.

• Acupuncture
• Alprostadil
• ARC1905
• AREDS2
• Avastin
• Bevasiranib
• Copaxone
• Cortical Implants
• Diet & Vitamins
• Eculizumab
• Fenretinide
• Macular Translocation
• Micro-Electrical Stimulation
• NT-501
• Photobiomodulation
• Radiation Therapy
• Retaane
• Retinal Implants
• Retinal Transplantation
• Rheopheresis
• RN6G
• RPE Transplantation
• Stem Cell Transplantation
• Submacular Surgery

See the cited website for details.

http://www.ahaf.org/macular/treatment/potential/

New Topical Eye Drop for the Treatment of Wet Macular Degeneration

Pazopanib, an investigational topical therapy for wet macular degeneration, shows positive beneficial results in clinical studies, Says Dr. Ilan Cohen, a New York City Ophthalmologist.

There are currently two drugs available for the treatment of Macular Degeneration: Lucentis, and Avastin. These drugs have been found effective both in preventing the progression of the disease and in improving overall visual acuity; however, both of these medications need to be injected into the eye with a needle every month, indefinitely, in order to prevent progression of the disease. In addition to the pain and the discomfort of receiving an injection into the eye each month, the patients are also exposed to the risk of a catastrophic eye infection due to a needle penetrating the eye. Moreover, the very high cost of the medication along with its administration by an Ophthalmologist can become a large burden on the healthcare budget and patients without insurance may not be able to afford it.

Pazopanib, on the other hand, can be administered as topical eye drops. The active molecule in Pazopanib works to prevent irregular blood vessels and subsequent bleeding under the macula. If this medication is proven effective in subsequent clinical studies and is approved by the FDA, patients with macular degeneration may be relieved of the nightmare of receiving monthly eye injections.

http://www.prweb.com/releases/2010/04/prweb3831544.htm

Doctor looking for participants for macular degeneration clinical trial

Dr. Ronald Frenkel of the  East Florida Eye Institute is looking for patients with wet macular degeneration to participate in a study.

Frenkel is looking in about a 75-mile radius for additional patients who want to be part of the study. His practice in Stuart specializes in macular degeneration and the clinical trial involves a new form of the drug Lucentis, one of the drugs that doctors hope can halt the progression of wet macular degeneration.

“When the FDA first approved the current Lucentis, it was given monthly, but it was shown that this strength of Lucentis wasn’t as effective when only given four times a year,” Frenkel said. “One of the parts of the test is to see if we use the stronger drug, a ‘super Lucentis’ we can reduce the frequency of the injections.” He said that those who participate in the clinical trial will either get the regular Lucentis or the stronger form of the drug.

Those interested in being evaluated as a possible clinical study participant should call the East Florida Eye Institute at (772) 287-9000.

http://www.tcpalm.com/news/2010/mar/05/stuart-doctor-looking-for-participants-for-trial/

Photodynamic Therapy No Help in Treating Wet Macular Degeneration

A study in Belgium shows Photodynamic therapy doesn’t add to the effectiveness of standard treatment of wet age-related macular degeneration or decrease the need for intravitreal injections, according to findings of a randomized controlled trial.

http://www.medpagetoday.com/MeetingCoverage/AAO/16697