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Alimera Sciences, Inc. (ALIM) Message Board

terry290737 40 posts  |  Last Activity: May 19, 2015 3:53 PM Member since: Dec 30, 2013
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  • Reply to

    Interesting read....

    by terry290737 May 19, 2015 10:00 AM
    terry290737 terry290737 May 19, 2015 3:53 PM Flag

    Not sure JD but the article hit me when reading it that maybe they should put Ashton on this one for Sustain drug delivery with a quick FDA approval like they did with that other story.

  • terry290737 by terry290737 May 19, 2015 10:00 AM Flag

    A NINE-YEAR-OLD girl who was told she could lose her sight has been given new hope thanks to experimental drug trials at Bristol Eye Hospital.
    Freya Hill, from Emersons Green, was diagnosed with juvenile idiopathic arthritis when she was just two years old, causing inflammation in her joints.
    Two years later, Freya's mum, Samantha Hill, was given the devastating news that her arthritis was threatening her sight.
    It became apparent to doctors that the inflammation had spread to her eyes, a condition caused uveitis. This can be catastrophic for affected children, leading in the long term to cataracts and blindness.
    Freya's sight could not be controlled with standard medication, which included steroid eye drops, so her mum took the difficult decision to enrol her on an experimental drug trial being pioneered by the Eye Hospital, called the Sycamore trial.
    Despite being daunted by the idea of doctors testing unknown drugs on her daughter, Samantha said she was desperate to save Freya's sight.
    She said: "At the first mention of a clinical trial, I felt there was no way I would let them try out new drugs on my child. It's amazing how quickly you change your mind when your child's sight is threatened and you suddenly realise those new drugs offer some hope.
    "Suddenly it became imperative that she was involved in the trial to give her a chance of accessing them."
    Freya had treatment for 18 months, which involved her mum giving her injections at home.
    Now she is nine years old, and her eyes are responding well, meaning there is a greater chance her sight can be maintained.
    Samantha said: "We feel so fortunate that we were able to give Freya this chance, the results have been incredible. Freya also knows what an important part she has played in the future of other children with arthritis and uveitis and how being involved in a trial will open treatment options for others."
    "We were so well looked after on the trial. Our nurse was always there to support us with learning to do the injections at home and we felt really safe. Her life has changed now. Before, she was having eye drops almost every hour, and now she just has the fortnightly injections."
    The trial, led by Bristol Eye Hospital and run across 14 sites in the UK, is funded by £1.5 million grant from the National Institute of Health Research (NIHR) and Arthritis Research UK.
    Juvenile idiopathic arthritis
    Juvenile idiopathic arthritis (JIA) affects young people, and the cause is unknown. Arthritis means inflammation of the joints, but in JIA the inflammation can also affect the eyes and internal organs.
    About 1 in 1000 children in the UK develop JIA, and about 40 per cent of them are at risk of uveitis.
    The sycamore trial is running to test a new drug which will reduce eye damage.
    Doctors were previously unaware of how helpful the drug could be in bringing down the inflammation, but patients like Freya have responded well.
    She is continuing her medication for the next two years.
    Diana Benton, head of research and innovation at University Hospitals Bristol, said: "We are delighted that taking part in research has been such a positive experience for Freya and her family, and would like to thank them for the time and commitment they have given to this trial.
    We know that visiting hospital for tests and treatment can be very stressful, and the decision by any patient to take part in research is a generous act which will benefit patients in the future by shaping the care we provide in the NHS."

  • terry290737 terry290737 May 19, 2015 9:18 AM Flag

    Ruruddy I see you pulled up my post from April 11th about FDA speeding up the process. I thought that medidur would be a prime candidate after reading the info from the FDA. This would be a great way for the FDA to redeem themselves after whàt they did to Iluvien.

  • terry290737 by terry290737 May 18, 2015 7:53 AM Flag

    May 18 (Reuters) - Eleven Biotherapeutics Inc said it does not see a path forward for its eye disease drug after it failed both main goals in a late-stage study.

  • Reply to

    Lily new R&D drug delivery center..related news

    by terry290737 May 13, 2015 10:11 AM
    terry290737 terry290737 May 13, 2015 1:55 PM Flag

    Tom the future is in drug delivery , I think many of us know that. Lilly is having some troubles but even they can see the direction of the future. The battle and the acceptance for most of the big pharma is that sustain drug delivery will decrease revenues, cutting back on repeat business. If they were smart they would see sustain drug delivery will open up a whole area of revenues

  • Lilly hopes new drug delivery R&D center will prove useful in osteoporosis, diabetes arenas.
    Eli Lilly announced last week that it will be opening a drug delivery and device innovation center in Cambridge, MA, as it seeks to meet the needs of its pipeline, such as a suitable formulation for its osteoporosis candidate, and maintain its leadership position in diabetes, where delivery devices are key.
    "New drug delivery and device innovation is critically important to Lilly's growing portfolio of potential medicines, particularly in our focus areas of diabetes, neurodegeneration, immunology and pain. The best therapies of the future will marry breakthrough scientific discovery with customer-friendly devices. That's what will make life better for people who need our medicines and give Lilly a true competitive edge," said Jan Lundberg, president of Lilly Research Laboratories, in a statement.

    Construction of the new center will begin immediately. Lilly says it will increase R&D space for drug delivery and devices by 50%. In addition about 30 researchers will be hired, increasing headcount in development of those arenas by 25%.
    The company recently downgraded its osteoporosis candidate, blosozumab, from Phase I to Phase II due to difficulty identifying a commercially attractive formulation, according to the most recent earnings call. Company officials previously touted the antisclerostin antibody, saying its effect was twice that of its own Forteo.
    In addition, the Lilly is working with AstraZeneca on an oral BACE inhibitor that treats Alzheimer's by cleaving a certain enzyme. History says the program has a low chance of succeeding due to delivery challenges associated with targeting the brain, but the payoff would be enormous. "The chemistry isn't hard. It's a pretty new target. There's lots of different strategies on accessing the target, including several of our own which have failed," said David Ricks, president of Lilly Bio-Medicines, during a healthcare conference in March. The program is in a Phase II/III trial.
    On the device side, Lilly is developing a proprietary formulation of Zosano's hormone for osteoporosis that's delivered via a microneedle patch system, instead of a daily injection. The candidate recently moved to Phase II, according to the most recent earnings call.
    Lilly most prominent therapeutic area is diabetes, which includes top-seller Humalog and its associated pens for convenient injections. But Lilly may soon have to ward off an oral competitor to Trulicity from Novo in the GLP-1 subspace.

    Lilly's Lundberg tried to downplay those concerns at a March health care conference: "So, of course, from a conceptual standpoint, it would be convenient for patients to have an oral application of a GLP-1, but I think it remains to be seen from the clinical efficacy, safety and, for the pricing perspective, cost of goods if it's viable or not."

  • (Amherst, NH) – As pharmaceutical companies struggle to position their products in the direct-to-consumer marketing era, the trend toward combining functionality and packaging in drug delivery systems is growing. Innovative drug delivery systems allow pharmaceutical companies to differentiate drug products from competitors. This is essential at a time when many patents are running out and competition among the manufacturers of generic medicines is increasing.
    The formulation of biologics is testing the limits of drug development. The use of polymers to stabilize protein and peptide drugs is growing, and advances in drying and reconstitution are providing new options. For drugs designed to be administered by the patient, therapy-specific packaging is improving compliance and treatment outcomes. In the area of delivery, reusable injection devices designed to accept prefilled syringes or drug cartridges is improving ease-of-use and increasing the alternative device share of the growing self-injection market.
    As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of drug therapies in non-traditional settings for a number of conditions. This trend is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that new drug product success no longer only depends on the medication itself but also on achieving a patient-friendly form of application.
    New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.
    New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

    These findings are contained in a new and comprehensive report, Injectable Drug Delivery to 2022: Evolving Markets, Emerging Opportunities. Growth of alternative injection devices is being driven by a number of factors, including improved patient compliance and patient quality-of-care, and the trend toward drug therapy self-administration.
    About Greystone Research Associates

    Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

  • Reply to

    So, Let's Just Look At Who We're Working With....

    by mickmack50 May 12, 2015 11:05 AM
    terry290737 terry290737 May 12, 2015 11:31 AM Flag

    Mick I would say yes to pfizer on glaucoma no to rochee and yes to regeneron. But the question still remains to be asked. Why after all this time why do we still have no agreement and no trials going on. This was back in August 2012.
    pSivida signs Tethadur agreement for protein delivery to the eye
    Evaluation agreement is the first commercial agreement for Tethadur
    August 1, 2012 | By Suzanne Elvidge
    Drug delivery developer pSivida ($PSDV) has signed a funded evaluation agreement with an undisclosed global biopharmaceutical company. This grants the biopharma company the rights to evaluate pSivida's Tethadur protein and antibody delivery system to treat eye diseases.

    The Tethadur delivery system is designed to deliver antibodies, peptides or proteins over long periods, and uses pSivida's BioSilicon technology, originally developed at the U.K. Department of Defense. This nanostructured porous silicon is engineered to include tiny holes, specifically sized and structured to carry the therapeutics and release them over time as the material erodes.

    "This is our first commercial agreement for Tethadur," said Paul Ashton, president and CEO of pSivida. "A sustained delivery system for these types of molecules would offer a significant clinical advance in the ophthalmic area where injections of protein-based drugs into the eye every one or two months are sometimes required."

  • terry290737 terry290737 May 12, 2015 8:15 AM Flag

    I agree we're are the specifics. Tell me what happen to the other two tech evaluation first back in 2012 and 2013. Investors are in the dark once again. Tech evaluation for how long 1 year 2years how long what drug and what company? Even BB OCT stocks give more information on a press release.

  • Reply to

    Catalyst

    by godwintom May 11, 2015 2:17 PM
    terry290737 terry290737 May 12, 2015 7:52 AM Flag

    Tom I hope your right but I don't see much going on here. As investors who have been here for years we are at a slow crawl. Possible buyout is not going to happen until data is released from Tethadur study or possible filing of phase 1. The HSS is still in beginning stages, with no filing as of yet. So now we are looking at 2017 for Medidur which is ok for the long term investor. The problem is I think most investors who are unaware of the process and dealing with the FDA are made to think it would happen much (Medidur) faster. The average investor who follows Psivida didn't see the second trial for a shorter duration of 6 months coming. So let's be honest about time frame here, are we talking about second half of 2017 or are we really talking about 2018 with FDA red tape. If we really are talking about 2018 then Psivida needs to tell investors that, if it happens sooner great. Company if too quite with information as we have seen in the past. So that brings us to upcoming catalyst, possible approval of another county for iluvien were it not available. With only one clinical trial going on that we actually know about Medidur, maybe we will here about the start of another beginning trial for another eye disease. Everything else seams to be a secret. God forbid we here actual news with regard to Psivida and other companies they are working with. Sorry to vent but it is frustrating to watch Psivida to hang their hopes on sales of Iluvien in order not to burn any cash. Most biotech companies have several trials going on. Not us. We just wait and hope someone takes notice.

  • St. Louis woman among first to try treatment for diabetic eye disease
    POSTED 9:57 PM, MAY 7, 2015, BY TOM O'NEAL
    ST. LOUIS (KTVI) – About 13 percent of all people with diabetes will develop diabetic macular edema. It’s a disease affecting the macula, the part of the retina responsible for central vision. Blood vessels in the retina begin to leak fluid and affect vision.
    Dr. Nancy Holekamp, director of Retina Diseases and the Center for Macular Degeneration at Pepose Vision Institute, says it’s the leading cause of moderate vision loss in people under 65 who have diabetes. She adds that means not being able to read clearly or drive unrestricted.
    Joy Ward, an author and consultant from south St. Louis, is among the 13 percent. She was diagnosed with diabetes in 1997. Joy eventually developed cataracts and had them removed. Within a couple of years, she noticed her vision was blurring and she had trouble with light. She was diagnosed with diabetic macular edema.
    Joy received some laser treatments and then began getting almost monthly shots of medication in her eyes to try to stop the leakage. She says doctors numb the eye and the shots really aren’t that bad, but having to go to the doctor so frequently interfered with her work and travel schedule.
    Last fall, the FDA approved Alimera Sciences’ ILUVIEN, the first long-term treatment for diabetic macular edema. Doctors inject a tiny pellet in the patient’s eye, which then releases a steroid over a three-year period to treat the edema.
    There are possible side effects. Because ILUVIEN is a steroid, Dr. Holekamp says it can cause glaucoma or worsening of cataract. So the best patients are those who have already undergone cataract surgery and have shown no adverse reactions to prior steroid treatments.
    Joy was a perfect patient.
    Dr. Holekamp was the first doctor in Missouri to give an ILUVIEN injection. Joy received her first injection with ILUVIEN in her right eye in March. A checkup just five weeks later showed impressive improvement in her condition. Dr. Holekamp called it remarkable. Joy was thrilled. A patient who had received 17 shots in her right eye over the past three years would now just receive one every three years going forward.
    Dr. Holekamp hopes to inject Joy’s left eye with ILUVIEN in about three months. Meanwhile, Joy’s trips to the doctor will gradually become less frequent, something she looks forward to.
    Joy says dealing with eye disease has meant having to slow down at times with her writing schedule, but she adds, “It’s better than being blind.”

  • terry290737 terry290737 May 5, 2015 7:19 AM Flag

    SA Article

    pSivida, Moore's Law, Pfizer, And The Next Regeneron

    May 4, 2015 • Austrolib
    PSivida is a biotech involved in ever smaller sustained-release delivery mechanisms for key drugs already on the market.
    With short term (days to weeks), medium term, and long term catalysts ahead, pSivida is an attractive choice for traders and investors alike.
    Having just received a $25M milestone payment, it is financially self-sufficient until 2017.
    Its Tethadur nanotechnology and its collaboration with Pfizer on a latanoprost microinsert have the potential in the long term to make it the next Regeneron.

  • Form SC 13D/A pSivida Corp. Filed by: PFIZER INC

    May 1, 2015 4:32 PM

    UNITED STATES
    SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549

    SCHEDULE 13D
    Under the Securities Exchange Act of 1934
    (Amendment No. 1)*

    PSIVIDA CORP.
    (Name of Issuer)

    Common Stock, par value $0.001 per share
    (Title of Class of Securities)

    74440J101
    (CUSIP Number)

    Margaret M. Madden, Esq.
    Vice President and Corporate Secretary,
    Chief Governance Counsel
    Pfizer Inc.
    235 East 42nd Street
    New York, New York 10017

  • People with diabetes are more susceptible to developing macular edema, a swelling of the retina, than those without. Fortunately, there are multiple treatments available, and one even has the potential to restore lost vision.

    Anti-VEGF Therapy
    The most groundbreaking treatment for diabetic macular edema to date hit the market about five years ago in the form of anti-vascular endothelial growth factor inhibitor (anti-VEGF) therapy, says Neil Bressler, MD, professor of ophthalmology and chief of the Retina Division at Johns Hopkins University School of Medicine. After the eye is numbed, these drugs are injected into the eye to stop blood vessels from leaking. Prior to that, the standard treatment was to use laser surgery to seal some of the vessels in the areas where leaks were occurring.

    While laser therapy could prevent further vision loss in many people, it could not improve vision in most people. Anti-VEGF therapy can. “Instead of 1 out of 6 people losing vision [with laser treatment] maybe 1 out of 20 people lose vision [with anti-VEGF treatment],” says Bressler. And instead of only a third of people improving with laser, two-thirds improve with injections, he says. “I’ve had many patients who are legally blind [and] whose vision has been restored to the point where many of them can now drive with anti-VEGF agents,” says Raj Maturi, MD, associate professor of clinical ophthalmology at Indiana University School of Medicine and partner at the Midwest Eye Institute in Indianapolis.

    There are three injectable agents currently on the market: ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). The Food and Drug Administration (FDA) has not approved Avastin for the treatment of macular edema, but studies have shown it to be an effective treatment. The medications are delivered in a series of injections, usually eight or nine in the first year and tapering off each year until you may no longer need injections.

    The Process: It may sound scary to have something injected into your eye, but Bressler says it’s painless. “We use a needle about the size of a hair, and with topical numbing drops, you feel like a hair pushing against the white part of your eye for second,” he says. After the injection, you can typically resume normal activity, though some people prefer to have a bandage over the eye for 15 minutes, especially on bright days, Maturi says.

    The Timeline: The treatment schedule can be pretty rigorous in the first year. “You have to get monitored almost monthly for a year to get it under control, and you’re often treated eight or nine times in the first year,” says Bressler. Treatment tapers off each year until, around the five-year mark, you may no longer need injections. “We try to convince people to stick with us,” he says, because if you can get it under control in the first year, you may not have a problem for the rest of your life. Continuing control of blood glucose levels is important, however.

    The Cost: The anti-VEGF agents can be very costly, particularly Lucentis and Eylea. Avastin is the least expensive because it’s used off label and is not packaged as an eye injection. Compounding pharmacies can dose Avastin for eye injections at a much lower cost. Based on a recent study from the National Eye Institute that compared the three agents, Medicare will cover Eylea at $1,960, Lucentis at $1,200, and Avastin at $70. With Medicare or Medicaid, there’s no residual cost. But for those with commercial insurance, the copay or direct cost may vary.

    The Comparison: The National Eye Institute study, which was conducted by the Diabetic Retinopathy Clinical Research Network and published in 2015 in the New England Journal of Medicine, compared the effectiveness of these three agents. The findings are important for how doctors will use these drugs, particularly because cost is an issue.

    They found that when starting vision loss was moderate or severe (20/50 or worse), Eylea showed greater visual improvement on average than Lucentis or Avastin. But, for people with mild vision loss (20/40 to 20/32), all three drugs showed similar average improvements. In addition, there were no major safety differences among the three agents.

    “I think the key here is that this study shows we have choices,” says Frederick Ferris, MD, clinical director and director of the Division of Epidemiology of Clinical Applications at the National Eye Institute. “Any of the three are effective, but especially for those with moderate to severe vision loss, the more effective one seems to be Eylea.”

    Keep in mind: These are averages of improvement for the drug, not for an individual, which means some participants saw greater improvements than others. And, because many factors go into the decision of which to use, these study results will help ophthalmologists and their patients to individualize the best treatment choice.

    Steroid Implants
    When anti-VEGF agents aren’t enough for a person with macular edema, Maturi will sometimes use a steroid implant to further reduce retinal swelling. “They work on the retina quite well due to their proximity,” he says. Although steroids are known to increase blood glucose levels, these implants contain too small of a dose to impact blood glucose control, says Maturi.

    You have two options: a dexamethasone intravitreal implant (Ozurdex) or a fluocinolone acetonide intravitreal implant (Iluvien). There is a difference in side effects, so discuss your options with your doctor.

    The Process: After the eye is numbed, a special applicator and 22-gauge needle are used to inject a tiny, rod-shaped implant into the white portion of the eye, near the retina.

    The Timeline: Ozurdex works for about four months. After that, swelling and inflammation may return. If this happens, you may need another implant. Iluvien works for about two years.

    Once you have an injection, your doctor will want to check your eye pressure because the implant may cause glaucoma. You also may experience temporary blurry vision after the injection, so arrange for a ride home ahead of time.

    The Cost: Maturi estimates Ozurdex costs about $1,500 per implant while Iluvien runs around $7,000.

    The Comparison: Because Iluvien lasts for two years—during which time the eye is constantly exposed to steroids—cataracts and glaucoma are likely to develop, says Maturi. According to clinical trial data for Iluvien, 82 percent of enrolled patients developed cataracts and 34 percent developed glaucoma.

    With those risks, some people with macular edema may skip treatment. But in certain cases, the risk is worth the reward: In a 2014 study published in the Journal of Ophthalmology, which compared effectiveness and side effects of these two steroid implants, researchers concluded that Iluvien was best used for people who do not respond well to anti-VEGF agents or who, due to frequent recurrences of macular edema, require treatment lasting more than four to six months. If a person is seeing results with Ozurdex, has no rise in eye pressure, but continues to need multiple injections, “Iluvien may be an option at that time,” says Maturi. For those people, this would mean fewer office visits to receive the injection (and thus fewer opportunities for infection) and less cost over the course of two years.

    But Ozurdex works for only four months, limiting a person’s steroid exposure. Because of this, eye complications usually don’t have a chance to develop as quickly. That gives doctors a bit more flexibility in dosing: They can assess patients after four months and decide whether or not to continue treatment.

    In some cases, Maturi will use triple therapy, using anti-VEGF agents, a steroid implant, and a laser therapy simultaneously.

  • Reply to

    anterior uveitis trial begins

    by mdhe51 Apr 16, 2015 10:24 AM
    terry290737 terry290737 Apr 17, 2015 12:22 AM Flag

    Mick you are correct about Dr. Stephen Foster as he is mentioned in Psivida's news release back in March 26, 2015.
    pSivida Corp. (NASDAQ:PSDV; ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced the completion of the originally targeted enrollment of 120 patients in its pivotal Phase III clinical trial of Medidur™ for the treatment of posterior uveitis, a blinding eye disease. pSivida will permit 10 additional patients seeking entry into the trial who met the entry criteria to enroll. pSivida expects to report top line data from the trial in the second half of 2016, and based on the results, to file for regulatory approval in late 2016 or early 2017.

    "This is a major advance in the treatment of uveitis, in my opinion, with the delivery of medication into the vitreous cavity without the need for travel to an operating room and with effective provision of corticosteroid for a sustained three years," said Dr. C. Stephen Foster, president and CEO of Massachusetts Eye Research & Surgical Institute; founder and president of Ocular Immunology and Uveitis Foundation and a clinical professor of ophthalmology at Harvard Medical School. Dr. Foster's site enrolled the most patients in the study.

    Medidur is an injectable micro-insert delivering the steroid flucinolone acetonide (FA) on a sustained basis for 36 months. Medidur uses the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for diabetic macular edema (DME) developed by pSivida, which has been approved in the U.S. and in 15 EU countries to date. Medidur is inserted via a redesigned applicator that utilizes a needle of the same gauge as that typically used for intra-ocular injections

  • New-eye implant helps diabetics with vision loss
    A new eye implant is on the market and it's available for people suffering severe vision loss due to diabetes.
    It is known as a Iluvien implant, and Dr. Pravin Dugel, managing director of Retinal Consultants Arizona, said he helped bring it to the market.
    It works by being inserted into the patient's eye and it slowly releases the drug fluocinolone acetonide, or FA, for up to three years.
    "The growth rate of diabetes around the world is in some cases 100 percent or more," Dugel said. "So this is not just a disease, it is an absolute epidemic. This will be the leading cause of blindness around the world."
    Dugel believes that about 50 percent of the diabetic patients could benefit from the implant.

    Sentiment: Strong Buy

  • Reply to

    Retina Health Center March 19, 2015

    by terry290737 Apr 15, 2015 8:00 AM
    terry290737 terry290737 Apr 15, 2015 12:02 PM Flag

    Southwest Florida Marketing Form March 19th 2015

  • Is Alimera Sciences (ALIM) Stock a Solid Choice Right Now? - Tale of the Tape
    The firm has seen solid earnings estimate revision activity over the past month, suggesting analysts are becoming a bit more bullish on the firm’s prospects in both the short and long term.

    I guess people are finally doing some research about how many people are receiving the implant here in the United States. With the small amount of Retina Specialist across the country, even if half are doing 5 to 10 units a quarter at about 8,000 a clip it will not belong before they turn profitable. Do your own leg work and make so call and you will see that this insert is going to make an impact on the market.

  • Retina Health Center now offers ILUVIEN, a new treatment for diabetic macular edema recently approved by the U.S. Food and Drug Administration (FDA). Retina Health Center Drs. Hussein Wafapoor and Alexander Eaton are the first physicians in the U.S. to treat diabetic macular edema (DME) patients with ILUVIEN since the FDA approval of the ILUVIEN implant for the treatment of DME. Diabetic Macular Edema is a complication of diabetes caused by accumulation of fluid in the macula or central portion of the eye and is a leading cause of vision loss in people with diabetes.
    An injectable implant, ILUVIEN is designed to release and maintain a concentration of steroids inside the eye for up to three years. A tiny tube is inserted in the back of the eye where DME typically forms, and the implant slowly releases a corticosteroid for 36 months. ILUVIEN was approved by the FDA to treat DME in patients who were previously treated with a course of corticosteroids and did not have a clinically significant rise in fluid pressure inside the eye.
    “This exciting technology is able to deliver a low-dose corticosteroid drug for three years or more and offers great promise for patients with this disease,” said Eaton. “Dr. Wafapoor and I are pleased to be the first retinal specialists in the nation to offer this exciting new option for patients with diabetic macular edema.”
    According to Eaton, the response of patients has been overwhelmingly positive. Prior to the approval of the ILUVIEN implant, patients typically required treatments every one to three months with Avastin, Lucentis, Eylea, Ozurdex and Triamcinolone. For patients receiving treatment with these older options, which are done by injecting a medication into the patients’ eye, the prospect of reducing the number of treatments from 36 to 1, in the best case scenario, to somewhere in between in patients with more advanced disease, is a positive one.
    “Hopefully, this will be the first of many advances that will help reduce the number of treatments for patients who receive frequent injections. We are excited that Retina Health Center is the first site selected to offer this promising medication, and we continue to work to bring new groundbreaking treatments to our patients as soon as they become available,” added Eaton.
    The ILUVIEN approval was based on clinical trial data, which showed that at month 24 after receiving the ILUVIEN implant, 28.7 percent of patients experienced an improvement of 15 letters or more from baseline in their best corrected visual acuity on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart. In other words, 28.7 percent of patients were able to see an improvement of three lines or more in their vision on the eye chart at the end of two years. By week 3 of follow-up, patients treated with ILUVIEN experienced a statistically significant improvement in visual acuity compared to the control group, and they maintained a statistically significant advantage over the control through completion of the trial at month 36.
    Tommie Gibson, who lives in North Fort Myers, received an ILUVIEN implant in his right eye on Jan. 22. In the past, he has required numerous eye injections of Lucentis and Triesence, and he is excited about the prospect of going three years without another treatment. Since receiving the very small device, which is significantly smaller than the lead of a pencil, Gibson has noticed an improvement in his vision.
    “Shortly following the ILUVIEN implant insertion, he has been able to read with the right eye using reading glasses, which he was not able to do before,” said Eaton. “His distance vision has also improved, and he can now see birds at a distance with that eye, something he could not do before the implant. It has been less than two months since he received the device, and he is looking forward to many more years of great vision without the need of additional injections.”
    Joan Kurek, who lives in Naples, received her ILUVIEN implant on Feb. 6 and is pleased with the progress she has seen.
    I’m now able to read fine print, like the numbers on a business card or the zip code on mail, which I was not able to do before the treatment,” said Kurek. “Overall, my experience has been positive and it’s helping me regain my self-confidence.”
    While some patients with more advanced disease may require combination treatments that include the older medications, the combined therapy in those patients seems to be working better and faster than monotherapy with the older agents and should result in better vision over the life of the device.
    “For patients with diabetic macular edema receiving frequent eye injections, as well as those with an incomplete response to Avastin, Eylea and Lucentis, this is a great option,” said Eaton.
    For patients with vascular disease who have had a stroke or heart attack, there is evidence to suggest that use of Avastin, Lucentis and Eylea may increase the risk of a stroke or heart attack. In addition, long term use of Avastin, Lucentis and Eylea can lead to elevated intraocular pressure, glaucoma, optic nerve damage and vision loss. ILUVIEN does not pose similar risks. While in some patients ILUVIEN may cause a rise in eye pressure, called ocular hypertension, in those eligible for the device under FDA guidelines, the FAME study found that ocular hypertension was manageable with eye drops. Although in patients who have not had cataract surgery, ILUVIEN will cause a cataract to develop, cataracts can be expertly managed by the many excellent cataract surgeons in the area. As with any medication, the benefits and risks of ILUVIEN should be reviewed with your eye doctor prior to use.
    Eaton suggests that patients receiving monthly or frequent injections should ask their eye doctor whether they would be a good candidate for this device. As the first and most experienced physicians using this device in the U.S., Drs. Wafapoor and Eaton are also available to help determine if ILUVIEN is an option for those who are considering it.
    Retina Health Center and the Macular Degeneration Research Center were established in 2002 by Dr. Alexander M. Eaton, a long-time Southwest Florida resident, who has been practicing ophthalmology in Lee and Collier counties for more than 20 years. Dr. Eaton has been the principal investigator for numerous studies to prevent and treat macular degeneration, and has invented numerous medical devices for use by patients and physicians that are used worldwide.

  • One stock that might be an intriguing choice for investors right now is Alimera Sciences, Inc. (ALIM). This is because this security in the biomedicine space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.

    This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably taking place in the biomedicine space as it currently has a Zacks Industry Rank of 45 out of more than 250 industries, suggesting it is well-positioned from this perspective, especially when compared to other segments out there.

    Meanwhile, Alimera Sciences is actually looking pretty good on its own too. The firm has seen solid earnings estimate revision activity over the past month, suggesting analysts are becoming a bit more bullish on the firm’s prospects in both the short and long term.

    In fact, over the past month, current quarter estimates have narrowed from a loss of 23 cents per share to a loss of 22 cents per share, while current year estimates have narrowed from a loss of 69 cents per share to a loss of 68 cents per share. This has helped ALIM to earn a Zacks Rank #2 (Buy), further underscoring the company’s solid position.

    So, if you are looking for a decent pick in a strong industry, consider Alimera Sciences. Not only is its industry currently in the top third, but it is seeing solid estimate revisions as of late, suggesting it could be a very interesting choice for investors seeking a name in this great industry segment.

ALIM
4.46+0.01(+0.22%)May 22 4:00 PMEDT