AMD

VEGF Trap-Eye

VEGF Trap-Eye received unanimous recommendation from an FDA drugs advisory committee for approval. The drug, now called EYLEA, is due for final FDA decision on August 20, 2011.

The advantage of this fusion protein (aflibercept) is that it will be administered every two months, after the initial three monthly doses. The present VEGF blocking drugs usually require ongoing monthly injections. A generally favorable safety profile was observed in the two Phase 3 trials of the drug.

 

Intraocular Implant For Drug Delivery

Dr. Balamurali Ambati, a Utah eye doctor, has invented a device to store and deliver medication to AMD patients, replacing the need for monthly injections. The implant, called iVeena, is a clear horseshoe-shaped ring that can be implanted in the area behind the eye’s lens during cataract surgery. It holds six to eight months of medication and can be refilled with new medicine through a needle and small valve, sparing the patient from ever having a direct injection. Although preclinical research is almost finished, it will take about five years for the device to be on the market.

AMD And Diet- What Twins Reveal

Why do twins have different stages of macular degeneration?, inquired Johanna M. Seddon MD, ophthalmologist and lead researcher of a study at Tufts Medical Center.

Promising Results With Stem Cells And AMD

Research on producing retinal cells from embryonic stem cells, induced pluripotent stem cells, and even the patient’s own skin cells, has been showing promising results at the University of Wisconsin-Madison's Waisman Center. David Gamm MD, and stem cell scientist, grew these cells and produced retinal cells that responded to signals involved in normal retinal function. He cautioned that there is much work left to be done but is encouraged by the potential.

One Company Reformulates Its Anti-VEGF Offering

On June 21, 2011, Ohr Pharmaceutical announced that they are advancing their clinical Wet Age-related Macular Degeneration program with a topical formulation. The anti-VEGF substance has been reformulated from an intravenous infusion to a topical eye drop. Phase one and two of this trial have shown a good safety and efficacy profile in both early and advanced Wet-AMD. “The Squalamine eye drop program has the potential to create a monumental shift in the way patients are treated for Wet-AMD,” commented Dr. Shalom Z Hirschman, Ohr’s Chief Scientific Advisor.

 

Stem Cells Derived From Skin Improve Vision

In an experimental study at Schepens Eye Research Institute, red mice were used to convert skin cells into retinal neurons and thus restore visual function. They found a significant increase in electrical activity in the newly reconstructed retinal tissue, signifying that connections were being made between the new photoreceptor cells  and the rest of the retina.   Michael J.

Priority Review of NEW AMD Drug

The FDA has granted a priority review for VEGF Trap-Eye, a new drug designed to stop the growth of abnormal vessels in the eye. Trap-Eye is a fusion protein that blocks the growth factors leading to neovascularization in macular degeneration. The priority review sets the decision date at August 20, 2011. Bayer and Regeneron are collaborating on the Trap-Eye treatment for wet AMD. Regeneron has exclusive rights to VEGF Trap-Eye in the US, while Bayer intends to market it outside the US.

 

Avastin vs. Lucentis

A press release just issued by the National Eye Institute states that a “NIH study finds Avastin and Lucentis are equally effective in treating age-related macular degeneration.” The CATT (Comparison of AMD Treatments Trials) study began in 2008 and now reports the results for 1,185 patients treated at 43 clinical centers in the United States. Patients received Lucentis monthly or PRN, or Avastin monthly or PRN.

Vitamin D and AMD

A study in the April issue of Archives of Ophthalmology reports that high levels of vitamin D appears to be associated with a decreased risk of developing early AMD in women younger than age 75. Women whose levels were the highest had a 59 percent decreased chance of developing early AMD. Once AMD was present vitamin D did not appear to have any effect on the condition. In women 75 years and older, higher levels were associated with a “borderline statistically significant increased risk.” Vitamin D food sources in the sample were milk, fish, fortified margarine and fortified cereal.

Avastin Safety Report

The Wall Street Journal and Marketwatch featured articles on the safety of Avastin.  Johns Hopkins University did an analysis of the Medicare patient claims database and reported that the use of Avastin for AMD showed a statistically significant increased risk for mortality and stroke as compared to Lucentis.  They cautioned that this analysis of 78,000 patients did not include information on smoking, lipid levels and blood pressure levels, all factors in mortality and stroke risk.

 

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