Antiangiogenic Drugs Are Stopping Neovascularization in Wet Macular Degeneration

(Updated 3/12/22)

A substance in the body called Vascular Endothelial Growth Factor (VEGF) is responsible for the growth of new blood vessels. It promotes this growth by stimulating the endothelial cells, which form the walls of the vessels and transport nutrients and oxygen to the tissues. Evidence shows that when the retinal pigment epithelial (RPE) cells begin to wither from lack of nutrition (a condition called “ischemia”), the VEGF goes into action to create new vessels. This process is called “neovascularization,” and it acts as a restorative function in other parts of the body. In the retina, however, the vessels do not form properly, and leaking results. This leakage causes scarring in the macula and eventual loss of central vision.

Antiangiogenic drugs prevent the VEGF from binding with the receptors on the surface of the endothelial cells. In most cases, the drugs are injected into the vitreous of the eyeball, then pass into the subretinal space, where the vessels proliferate. Neovascularization is then blocked, preventing bleeding into the retina.

New research is looking for less invasive and burdensome introduction of the drugs by way of topical eye drops, implanted timed release capsules, and implanted ports of delivery. The most recent breakthrough is FDA approval of Susvimo. This procedure continuously delivers a form of ranibizumab (Lucentis), offering an alternative to anti-VEGF eye injections. The tiny implant is surgically inserted into the eye during a one-time outpatient procedure and refilled every six months. More about Susvimo.
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Here is information on current anti-angiogenic drugs being studied or already being used in the clinics:

In clinic use:
Macugen (pegaptanib sodium) [approved 2004]
Lucentis (ranibizumab) [approved 2006]
EYLEA (aflibercept) [approved 2011]
Avastin (bevacizumab) [available off-label since 2007]
Brolucizumab (RTH-258) [approved 2019]
Byooviz (ranibizumab-nuna) [approved 2021]
Faricimab (Vabysmo) [approved 2022]

Under study:
Abicipar
AKST4290 (oral)
AR-13503
EYP-1901
GB-102
IBI302
ICON-1
KSI-301
OPT-302
PAN-90806
RBM-007
RGX-314
X-82 (oral)


Macugen (pegaptanib sodium)
Macugen, made by OSI EyeTech Pharmaceuticals, was the first antiangiogenic drug to gain FDA approval. Pegaptanib is a chemically synthesized strand of genetic material that bonds with VEGF cells to block replication. A large trial of Macugen on 1,196 patients at 117 centers around the world was completed in 2003. In November of that year, data presented to the American Academy of Ophthalmology (AAO) showed that Macugen stabilized or improved vision in 33% of the patients in the trials, while the same results occurred in 23% of a control group not given Macugen. As many as 71% of the patients given Macugen lost less than three lines of vision during the year, compared with 55% in the control group. The drug is injected directly into the eye every six weeks, or about nine times a year.
Working in conjunction with Pfizer Ophthalmics, Macugen gained FDA approval on December 17, 2004, and was ready for public use beginning in 2005.

Lucentis
Genentech, Inc. announced on May 23, 2005 that a Phase III clinical study of the investigational drug Lucentis (ranibizumab) met its primary efficacy endpoint of maintaining vision in patients with wet AMD. Approximately 95 percent of patients maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) at one year when treated with Lucentis injections compared to approximately 62 percent of those treated in the control arm. Vision improvement was an unexpected result that had not been seen at a significant level in other antiangiogenic drug trials. Lucentis is approved for use in the European Union, Switzerland, India, Canada and the United States. A regulatory decision in Australia is expected before the end of 2007.
On January 14, 2006, one-year data from the second pivotal Phase III study of Lucentis were presented at the Macula 2006 meeting in New York. Data showed that, for the second time in a large, Phase III study, Lucentis improved vision in patients with wet AMD.
On November 13, 2006, several new findings were presented at the 2006 AAO meeting:
Elias Reichel, M.D. reported that in the MARINA trials, there was improvement at all visual acuity levels, but there was not a big difference if the patient’s baseline vision was either low or excellent. This “floor-to-ceiling” effect is not unusual with this kind of study, but it is useful information for patient communicating with patients about expectations.
Nancy Holekamp, M.D., discussed key anatomic endpoints in the MARINA trials, in particular, the total lesion area over time (no growth of the lesion area was noted in the treated patients), the mean area of leakage (the amount of decrease was statistically significant) and the mean foveal retinal thickness (treated eyes showed a significant thinning of the retina). The bottom line is that all anatomic outcomes from the trial favored Lucentis, and the treatment is so effective over a long period of time without any signs of toxicity, there is no indication that anything in lieu of Lucentis should be used to treat wet AMD.
Peter Kaiser, M.D., reported on subgroup analysis of Genentech’s PIER study. The primary endpoint was met, showing a difference of 16 letters visual acuity between the treated group and the sham group. Further, the dosing regimen was effective, but the visual acuity benefit was not as robust when injections went from monthly to quarterly. The persistence of monthly injections may depend upon who has dry lesions and who has wet lesions at the 5th month. The dry lesion group did better than the wet lesion group with quarterly dosing. This data is pointing toward better prediction of dosage outcomes for individual patients.
On February 15, 2007, Dr. Kaiser reported two-year results of the Phase 3 ANCHOR trial comparing Lucentis with photodynamic therapy (PDT) for wet AMD. The study showed that Lucentis helps maintain vision, with few adverse effects, significantly better than PDT. 89.9% of patient randomised to Lucentis in a head-to-head comparison with Visudyne for photodynamic therapy (PDT) lost fewer than 15 letters on a visual acuity chart at 24 months compared to 65.7% of those treated with PDT. 78% of the Lucentis-treated group maintained their baseline visual acuity or gained letters, compared to only 29% of the PDT group. Overall, patients randomised to Lucentis had a 20.5 letter benefit at 24 months (+10.7 EDTRS letters) compared to those treated with PDT (-9.8 letters). This was similar to visual acuity seen at 12 months (+11.3 letters with Lucentis vs -9.6 letters with PDT).
On February 23, 2008, the final results from Cohort 1 of the Phase IIIb SAILOR study of Lucentis in patients with wet AMD were presented on February 23, 2008 at the Bascom Palmer Eye Institute’s Angiogenesis meeting by Dr. David Boyer (Retina-Vitreous Associates Medical Group, Los Angeles). The final, one-year data support the long-term safety and efficacy profile of Lucentis.
The study, titled “Ranibizumab (Lucentis) Safety in Previously Treated and Newly Diagnosed Patients with Neovascular Age-related Macular Degeneration (AMD): The SAILOR Study,” was designed to evaluate the safety of two different doses of Lucentis (0.5 mg, the FDA-approved dose, and 0.3 mg) administered once a month for three months and thereafter as needed based on re-treatment criteria.
For more detail in all of these areas of study, see www.lucentis.com.

EYLEA (aflibercept injection, formerly VEGF Trap-Eye)
In August 2008, Regeneron Pharmaceuticals, Inc. and Bayer HealthCare AG announced that patients with wet AMD receiving EYLEA (aflibercept injection) in a Phase 2 extension study on an “as needed” dosing schedule continued to show highly significant improvements in retinal thickness and vision gain at 52 weeks. There were no drug-related serious adverse events, and treatment was generally well-tolerated.
For all dose cohorts combined, there was a 5.3 mean letter gain in visual acuity at the end of 52 weeks. The mean decrease in retinal thickness was 130 microns versus baseline. During weeks 12 to 52, patients from all dose groups combined received, on average, only two additional injections. This supported Regeneron’s expectation that, with EYLEA treatment, patients’ visual acuity would improve over time without the need for monthly intravitreal injections.
A phase 3 study, VIEW 1, began enrolling patients in late 2007. The VIEW 1 study compared EYLEA and Lucentis. A phase 2 study in diabetic macular edema (DME) was also completed. EYLEA injected into the eye every two months was found to be as effective as monthly doses of Lucentis, and monthly monitoring of patients receiving EYLEA was not necessary.
On June 17, 2011, the Food and Drug Administration advisory panel voted unanimously to recommend EYLEA as a treatment for wet AMD. The advisers also said the injected drug could be given once every two months. This was an improvement upon the typical 4-6 week dosings of both Lucentis and Avastin.
Finally, on November 18, 2011, Regeneron announced that the FDA had approved EYLEA for treatment of patients with wet AMD. Recommended dose is 2 mg every four weeks for the first 12 weeks, followed by 2 mg every eight weeks. EYLEA offers less frequent injections than either Lucentis (4 weeks) or Avastin (6 weeks), and there are no monitoring requirements.
Since September 2012, Eylea has also gained approval in the U.S., Europe, and Japan for use in treating wet AMD, diabetic macular edema, and neovascular myopic degeneration. For more information, see www.regeneron.com.

Avastin (bevacizumab)
Avastin (bevacizumab), has been shown in preliminary off-label studies to stop blood vessel growth and leakage in the retinas of patients with macular degeneration. Testing began in March 2005 at the Bascom Palmer Eye Institute in Miami under the leadership of Dr. Philip Rosenfeld. In July 2005, Dr. Peter Campochiaro followed with subjects at the Johns Hopkins Medical Center in Baltimore. Potential side effects, according to Rosenfeld, are increased risk of stroke or heart attack in patients taking chemotherapy, and elevation of blood pressure. Systemic infusions of Avastin, he said would be needed every few months.
On February 15, 2007, Elias Reichel, M.D. reported to Hawaiian Eye/Retina 2007 that Avastin has shown good results in a small retrospective case series for treatment of neovascularization from myopic degeneration. 15 eyes studied showed a mean improvement in acuity of 3 lines, central foveal thickness decreased an average of 93 micrometers and no complications.
In May 2011, first year results of the Comparison of AMD Treatments Trial (CATT) were announced. The report focused on the relative safety and efficacy of Lucentis and Avastin. After one year, the two compounds have been found to be extremely similar in their improvement of mean visual acuity and the occurrence of adverse events. Five related trials were also undertaken in the UK and Europe.
At the end of the 2-year comparison study, The National Institutes of Health reported that both drugs improved vision when administered monthly or on an as needed basis. Patients receiving Lucentis, however, fully maintained first-year vision gains with an average 5.7 injections in the second year. In contrast, patients treated with Avastin experienced a greater decline in vision despite receiving significantly more injections over the two year period. In addition, secondary anatomical outcomes were significantly better with Lucentis. For more information, see www.nih.gov/news/health/apr2012/nei-30a.htm

Faricimab (Vabysmo)
A global Phase III program for faricimab in wet AMD began in 2019. The efficacy of faricimab administered at 12- and 16-week intervals was evaluated against ranibizumab every 4 weeks. At week 24, researchers reported in May 2020 that 65% of faricimab-treated patients were disease activity-free. By January 2021, further research had shown that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes as effective as those receiving Regeneron’s aflibercept (Eylea) injections every eight weeks. More information.

PAN-90806
PAN-90806 is a topical eye drop for the treatment of neovascular AMD, diabetic retinopathy, and potentially diabetic macular edema (DME). It is being developed by Panoptica and began a phase 1 clinical trials in early 2014, a 2-month open-label study of approximately 30 patients at 15 to 20 sites in the U.S. The study was completed in May 2016. More information.

OPT-302
OPT-302 is soluble receptor developed by Opthea Pty Ltd. It is a derivative of VGX-300 which has been optimised for local ocular administration. OPT-302 potently and specifically blocks VEGF-C and VEGF-D from binding and activating VEGFR-2 and VEGFR-3.
On August 6, 2019, Opthea announced positive Phase 2b results demonstrating that OPT-302 combination therapy showed improvements across multiple secondary endpoints at 24 weeks. Compared to Lucentis monotherapy, OPT-302 (2.0 mg) combination treatment showed improvements that included a higher proportion of patients with stable vision (defined as ≤ 15 letter loss from baseline), and those gaining ≥10 and ≥15 letters of visual acuity. On March 15, 2021, Opthea announced that, based upon the positive Phase 2 results, the first patient has now been enrolled in the Phase 3 trial. More information

ICON-1
The EMERGE study examined the hypothesis that a protein called Tissue Factor (TF), when out of control, initiates inflammation and angiogenesis, resulting in wet AMD. ICON-1 is thought to block the protein and reverse the progression of the disease, both alone and in combination with Lucentis.
Phase 2a results showed that ICON-1 was well tolerated and that in combination with anti-VEGF therapy treated both the symptoms and the underlying process driving inflammation and CNV. The combination effectively reduced CNV lesion size, increased the durability of effect and improved removal of pathologic fluid from the retina. Based on these positive results, the company initiated a Phase 2b study of ICON-1 in combination with anti-VEGF treatment in 2018. More information

RGX-314
Regenxbio’s RGX-314 differs from current therapeutics in that it includes a gene vector (NAV AAV8) which encodes an antibody fragment designed to neutralize VEGF (vascular endothelial growth factor) activity. This modifies the pathway for formation of new leaky blood vessels which lead to retinal fluid accumulation and vision loss.
In August 2019, Regenxbio reported positive phase 1/2a results in patients with wet age-related macular degeneration, and that the drug is continuing to be well tolerated across five dose cohorts.
Investigation of RGX-314 with a phase IIb trial (AAVIATE) is proceeding, with dosing of the first patient using suprachoroidal delivery. As of December 31, 2020, suprachoroidal delivery of RGX-314 was reported to be generally well-tolerated, with no evidence of inflammation.

More information

Brolucizumab (RTH258)
Novartis announced on October 8, 2019 that the US Food and Drug Administration (FDA) approved BEOVU® (brolucizumab-dbll) injection for the treatment of wet age-related macular degeneration (wet AMD).  BEOVU® carries a recommended dosing schedule of monthly for the first three doses followed by one dose every 8-12 weeks. More information.

Abicipar
Allergan trials have demonstrated that the biological drug Abicipar is equal to Genentech’s Lucentis (ranibizumab), with the added benefit that Abicipar treatments are effective at up to 12-week dosages. This is longer than Lucentis (4 weeks), Avastin (6 weeks), and Eylea (8 weeks), the three currently available drugs for treatment of wAMD. Trials are ongoing. More information

KSI-301
Kodiak trials showed good results for treatment of diabetic macular edema. Twelve weeks after a single dose of KSI-301 saw improvement of almost two lines (9 eye chart letters) and retinal edema of 121 microns. Unfortunately, Phase 3 results showed that, although KSI-301 demonstrated strong durability and was safe and well tolerated, it did not meet the primary efficacy endpoint of showing non-inferior visual acuity gains for subjects dosed on extended regimens compared to aflibercept given every eight weeks. More information.

GB-102
Graybug Vision’s novel investigational depot approach is designed to continuously inhibit activity of all VEGF receptors for the treatment of wet AMD. In Phase 1 trials, GB-102 was well-tolerated with no dose limiting toxicities, drug-related serious adverse events or inflammation. 88% and 68% percent of evaluable patients were maintained only on a single dose of GB-102 at 3- and 6-months, respectively. Patients with wet-AMD require intravitreal injections every 6 to 8 weeks, on average, with the current standard-of-care.

Graybug Vision’s Phase 2b ALTISSIMO study of GB-102, was completed in January 2021. Topline data are expected to be announced in the second quarter of this year, and full results presented in the later part of 2021 at a medical conference.

Graybug announced in April 2022 that it plans to proceed with a Phase 2 clinical trial of an optimized formulation of GB-102 in wet AMD patients following successful demonstration of improved performance in an extensive battery of novel in vitro stress tests. This decision, supported by a significantly more favorable competitive landscape following recent readouts of other long-acting vascular endothelial growth factor (VEGF) inhibitors, is anticipated to result in a six-month data readout available in the third quarter of 2023.

More information

X-82 (Oral)
Under study by Tyrogenex, Inc., this oral medication is intended for use in combination with anti-VEGF injections. The expectation is that the combination therapy will reduce the number of injections required for stabilizing the retina. Phase 2 trials began in 2017. More information.

AKST4290 (Oral)
Alkahest Inc. has reported that AKST4290, an oral medication for treatment of wet AMD, was shown in trials to be safe, effective, and “extremely promising”. Two Phase 2a clinical trials for AKST4290 were recently completed: one in naïve patients and one in refractory wet AMD patients. Results are pending. More information

IBI302
In April 2019, Innovent Biologics announced that it had dosed the first patient in a phase 1 trial of IBI302, the company’s wet AMD treatment candidate. A single intravitreal injection of IBI302, a recombinant fully human bispecific fusion protein targeting VEGF and complement proteins, will be evaluated in 36 patients with wet AMD in the open-label, single-center, dose escalation clinical trial. More information

AR-13503

In August 2019,  Aerie Pharmaceuticals, Inc. (Aerie), began patient dosing in their first human clinical trial of a sustained release implant in patients with wet macular degeneration or diabetic macular edema. The polymer implant provides controlled release of AR-13503, an injectable drug that inhibits blood vessel growth in the retina, while potentially reducing the treatment burden associated with more frequent intravitreal injection. More information

RBM-007
RBM-007 is a novel oligonucleotide-based aptamer with potent anti-FGF2 (fibroblast growth factor 2) activity. A Phase 2 Study assessing the safety, efficacy and durability of RBM-007 is underway. More information

Byooviz (ranibizumab-nuna)
The first biosimilar to ranibizumab injection for wet AMD. Also approved to treat macular edema and myopic choroidal neovascularization. More information.

EYP-1901
A potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration (wAMD). More information

Summary of Research and Developments in Macular Degeneration, 2010-2011

by Dan Roberts
June 19, 2011
Introduction
Since 2006, I have done my best to condense the high points of the previous year’s macular degeneration research into a single report that is concise and understandable for the layperson. I do so, because I understand first hand how important it is to be aware of everything being done on our behalf by the scientific community. Fear of the unknown is often the worst part of this disease. Information, therefore, is an effective weapon that we should all have access to.
Developments in the field of low vision treatment are occurring at an exponential rate. So fast that vision restoration and cures could conceivably become realities in some of our lifetimes. Through the years, we have seen impressive achievements in the areas of surgery, nutrition, and pharmacology. This past year, pharmacology has taken the lead, so most of this summary will discuss the drugs that are now under development and in clinical trials.
PHARMACOLOGY
Results From the Comparison of AMD Treatments Trial (CATT)
The most interesting development this past year was the findings from the Comparison of AMD Treatments Trial (CATT), sponsored by the National Eye Institute. This trial was designed to study the relative safety and efficacy of Genentech’s Lucentis, the approved treatment for wet AMD, and off-label Avastin, a similar, but less expensive drug originally developed by the same company for treatment of colon cancer. At the end of the first year of the two-year trial, the two compounds have been found to be extremely similar in their improvement of mean visual acuity and in the occurrence of adverse events.
These are top line results, with more detail to come later. Meanwhile, the subjects will continue under observation as the trial proceeds through its second year. Five related trials are also underway in the UK and Europe, all of which deserve watching for potential new findings.
In addition to the general findings, the results also revealed surprisingly little difference in the efficacy of scheduled injections and the efficacy of injections delivered on an as-needed basis for both drugs.
The general consensus of opinion among doctors using Avastin is that they will continue using the drug off-label. At the same time, they will ensure that patients are fully aware of adverse events (SAE) that have been determined at this time to be neither significant nor insignificant to the end results. No discussions have yet been held with the Centers for Medicare and Medicaid Services (CMS) regarding changes in policy for reimbursement for Avastin as a treatment for wet AMD.
Another report will be published following conclusion of the trials next year. Meanwhile, it is important that patients discuss their treatment with their doctors for a full understand of the current findings.
Fenretinide
ReVision Therapeutics’ Phase 2 trials have been completed with a surprising outcome. In addition to expected positive results, researchers have found that the drug fenretinide, taken orally once a day, also reduces by 2.2-fold the rate of conversion to neovascularization (hemorrhaging) in patients with geographic atrophy (end stage dry AMD). This means that fenretinide, in addition to slowing the progression of dry AMD, could also become a pre-treatment for wet AMD, a condition that is responsible for 85-90% of AMD related vision loss.
As a result of these findings, the scientists hope to move forward to a larger phase 3 clinical trial to evaluate this therapeutic effect in a larger patient population.
Lucentis “Super Dose”
Genentech’s HARBOR trial has revealed that a higher dose of Lucentis (ranibizumab) for treatment of wet AMD has been found to be more effective in fifty “incomplete responders” over 24 months. “Incomplete responders” are individuals who have shown no appreciable response to the normal treatment. Intravitreal injection with 2.0 mg, however, rather than the current 0.5 mg, led to a significant decrease in retinal thickness (swelling) after the first 3 months, plus a 4-letter gain after 8 weeks. This improvement was maintained up to one year with no serious adverse events.
AL-8309
Alcon Pharmaceuticals Company is developing a topical drug, AL-8309, which, when given one to two times daily has been shown to block the inflammatory response in rodent retinas exposed to blue light. Since inflammation is thought to be a contributor to development of AMD, and since AL-8309 inhibits the complement system that initiates inflammation, the drug is showing promise as a potentially effective treatment for dry AMD.
VEGF Trap-Eye
Regeneron Pharmaceuticals, Inc. and Bayer Health Care, have entered phase 3 trials comparing the anti-angiogenic drug, VEGF Trap-Eye, with Lucentis for treatment of wet AMD, central retinal vein occlusion (CRVO), and diabetic macular edema (DME). The drug is expected to improve patients’ visual acuity over time without the need for monthly intravitreal injections.
In the Phase 3 GALILEO study, patients with CRVO received six monthly injections of either VEGF Trap-Eye at a dose of 2mg or sham injections. At the primary endpoint patients gained 15 letters of vision from baseline. At a secondary endpoint they gained, on average, 18 letters of vision. These early findings showed that VEGF Trap-Eye has the potential to provide patients and physicians a new treatment option for central retinal vein occlusion.
Regeneron is now seeking marketing approval for treatment of CRVO in the United States. Bayer HealthCare is planning to submit regulatory applications in Europe in 2012.
Lucentis
The current treatment protocol is recognized by the company as a burden on patients. Researchers are, therefore, working on ways to improve the delivery method. One possibility is reduction of frequency of injections.
Practitioners are finding that not all patients are responding as expected with Lucentis. About 10% of patients have actually lost 2-3 lines of acuity after treatment. To address this issue, the new DAWN study will identify ahead of time, by means of a blood test, how well a patient will respond to the drug. Treatment could then be adjusted for best benefit. Genentech scientists are also looking at potential genetic causes for those patients who are not responsive to Lucentis.
As a side note, Novartis Pharmaceuticals Corporation is initiating a 5-year patient management study (LUMINOUS) to gain further understanding of long-term effectiveness of Lucentis, treatment patterns, long term safety, and health-related quality of life issues. The study was launched in 34 countries in March 2011.
NT-501
Another drug, NT-501, developed by Neurotech, is a treatment designed to protect, and in some cases rescue, dying photoreceptors in the retina in order to preserve vision. This treatment relies on a growth factor produced by the human body called neurotrophic factor (CNTF). Human cells engineered to produce CNTF are implanted in the eye in a tiny specially designed capsule which protects these cells from the patient’s immune system and continually releases a small amount of the growth factor. Neurotech has announced that this so-called encapsulated cell technology (ECT) has completed Phase 3 trials with good results.
There have been no serious ill effects associated with the treatment or with having the capsule implanted. NT-501 is also being tested as a treatment for other retinal degenerative disorders including retinitis pigmentosa.
New Treatment Possible for Dry AMD
A new study published in the February 2011 journal Nature reports that dysfunction of an enzyme called DICER1 may be a cause of geographic atrophy (dry AMD). Researchers at the University of Kentucky found that levels of the enzyme are higher in healthy retinas than in eyes affected by AMD. They demonstrated that low DICER1 levels lead to buildup of a toxic genetic material called alu, This, in turn, causes geographic atrophy (dry AMD).
Two treatments may potentially halt the progression of the disease: one which boosts levels of the enzyme, and the other which breaks down the toxic Alu RNA. To test the hypothesis, the University of Kentucky is planning to start human trials by the end of 2011.
SURGERY
Human Retinal Cells Developed From Non-embryonic Stem Cells
On March 24, 2011, Georgetown University Medical Center reported in the journal “Stem Cells” that their researchers have, for the first time, produced retinal cells from human induced pluripotent stem (hiPS) cells, rather than embryonic stem cells. hiPS cells are derived from the patient’s own body, thus bypassing the moral issue of using human embryos.
This is an important step in the research, but several viability and safety issues still need attention before hiPS cells can be introduced into humans.
Microplasmin for vitreal adhesion
A single intravitreal injection of a new drug called microplasmin has been shown in Thrombogenics’ Phase 3 trials to relieve adhesion of the vitreous (the gel that fills the inside of the eye) to the inside of the retina. This reduces risk of damage from the tugging of the vitreous on the retina, which can lead to such conditions as diabetic vitreous hemorrhage and macular hole. It accomplishes this by inducing a gentle post vitreous detachment (PVD), and that can help eliminate the need for surgery to remove the vitreous from the eye.
Implantable Miniature Telescope Approved
VisionCare Ophthalmic Technologies, Inc. announced on July 6 that the FDA approved the company’s Implantable Miniature Telescope to improve vision in patients with end-stage AMD.
The telescope implant is designed to improve visual acuity. The magnification provided by the implant reduces the impact of the blind spot caused by end-stage AMD.
VisionCare will conduct a post-approval study to monitor patient outcomes under commercial conditions. A second smaller study will follow clinical trial patients for an additional two years.
VisionCare is submitting an application to the Centers of Medicare and Medicaid Services for a new code to establish Medicare beneficiary access to this implantation procedure. For more information about the telescope implant and related treatment program, see www.centrasight.com.
Radiation Therapy Continues To Show Promise
In October, NeoVista made public the company’s one-year results from the preliminary study MERITAGE-I. The study was designed to examine their radiation procedure (epimacular brachytherapy) for patients undergoing chronic therapy with anti-VEGF agents for wet AMD. Study results showed that a single radiation treatment stabilized visual acuity in 79% of this patient population, while decreasing the number of anti-VEGF injections required. Most importantly, 47% of patients enrolled in the study experienced some improvement in their visual acuity, while 10% of patients gained 15 or more letters of visual acuity at 12 months.
The study results also pointed to a favorable trend with respect to a reduced number of anti-VEGF injections following delivery of radiation versus the period of time leading up to the intervention. In addition, 25% of patients remained injection-free at 12 months following the procedure.
NUTRITION
AREDS2
The National Eye Institute’s second Age-Related Eye Disease Study (AREDS2) is continuing. The original AREDS formula was approved in 1998. This time, subjects are being given a slightly altered formula containing the original vitamin dosages minus beta-carotene, a lower dosage of zinc, and addition of lutein, zeaxanthin and omega-3. The purpose is to see if the revised formula will help even more to slow the progression of AMD to the advanced stages. The new study began in June 2008, and results are expected in the year 2013. Meanwhile, many nutriceutical companies have gone ahead and updated their products to reflect the more current research. It is advisable to discuss with all of your professional care providers any additions or changes in your diet or supplementation.
TECHNOLOGY
iPad2
The most common complaint about low vision technology is the high price of assistive devices. With government assistance available only to veterans, many people simply cannot afford to purchase the products that can make their lives so much easier. With this year’s introduction of Apple’s new iPad 2, however, that has almost become a non-issue.
For less than half the cost of most electronic magnifiers, visually impaired people can now own virtually every low vision gadget all wrapped up in a device no larger than a thin book. The iPad2 can read to you in 21 languages, magnify images and text, tell you what color your shirt is, guide you across town, magnify the face of your grandchild, call a friend, shop online, manage your finances, identify currency, help you type a letter, read Braille, tell the date and time, and so much more. And it can all be done using tactile buttons or touch screen controls. Apple also offers a year of personal training on the iPad2 for $99.
This has set the standard, and we can now expect more advances at even lower prices to come our way. And if that doesn’t brighten your day, read on:
Driving Blind
The National Federation of the Blind announced on January 29, 2011 that, for the first time, a blind individual has driven a street vehicle in public without the assistance of a sighted person.
The car was equipped with laser range-finding sensors that conveyed information to a computer inside the vehicle, allowing it to create and constantly update a three-dimensional map of the road environment. The computer sent directions to vibrating gloves on the driver’s hands, indicating which way to steer, and to a vibrating strip on which he was seated, indicating when to speed up, slow down, or stop.
Also this past year, Google revealed it’s own version of what they call an autonomous vehicle. The company has been working in secret on vehicles that can drive themselves.
According to the New York Times, seven Google test cars have driven 1,000 miles without human intervention and more than 140,000 miles with only occasional human control. One even drove itself down Lombard Street in San Francisco, one of the steepest and curviest streets in the nation. The only accident, engineers said, was when one Google car was rear-ended while stopped at a traffic light.
They say this technology may be available to the public in eight years. If that happens, one of the thorniest problems of low vision, transportation, will no longer be an issue.
AMD Numbers Continue to Fall
“The number of Americans with macular degeneration fell 30 percent in about two decades,” according to a study published in the January issue of the Archives of Ophthalmology, “reducing the threat from the leading cause of [visual impairment] among the elderly.”
The study authors explained that “Reductions in smoking and blood pressure, key risks for the condition, and increased use of antioxidant vitamins that keep the disease at bay may account for the decline”. The study also revealed that the rate of advanced AMD among all the participants was 0.8 percent, and that AMD affects approximately 6.5% of adults ages 40 and over, compared with the previous estimate of 9.4%.
Data was obtained from 7,081 people, aged 40 and older, who took part in the 2005 to 2008 National Health and Nutrition Examination Survey.
Other research has been confirming this trend. In 2007, a study found a lower 5-year incidence of early AMD in patients born or examined more recently, compared to similarly aged persons born or examined in an earlier period. 2,968 participants with early AMD and 3,588 participants with late stage AMD were examined at 5-year intervals between 1988 and 2005 as part of the Beaver Dam Eye Study.
Then, in 2010, a study reported to the Association for Research in Vision and Ophthalmology showed a 68% lower incidence of macular degeneration in the Baby Boom population. That research suggested that improvements in environment, behaviors, and other such modifiable factors may have contributed to the results. The “birth cohort” effect remained even after adjusting for AMD risk factors such as obesity, heavy drinking, and sunlight exposure.
The results of this research further emphasize the importance of environmental and lifestyle factors to retinal health.
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This wraps up my summary for this year. I hope you will share this information with your family, friends, and doctors. You are in a position to help others understand, and by doing so, you will be serving a valuable purpose. Thank you for your help!