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Iluvien Treats Diabetic Macular Edema for 3 Years

US ILUVIEN LOGOIluvien is now available in the United States!  Finally receiving FDA approval in late 2014, the injectable sustained release intravitreal implant  is on the market.

Alimera Sciences states that Iluvien (sustained release of fluocinolone) will release its drug for up to 3 years.

Iluvien Treats Diabetic Macular Edema

Diabetic macular edema is the most common vision threatening complication of diabetic retinopathy.  In essence, normal blood vessels of the retina become leaky due to the diabetic retinopathy.

Fluid accumulation in or near the center of the macula is called diabetic macular edema (DME).  This is also known as clinically significant macular edema (CSME) if you are a doctor.

DME often causes blurry vision and in extreme cases can cause legal blindness.

Therapy is aimed at stopping the leakage.  With time, the macular edema may “dry up.”

Treatment options include laser, anti-VEGF (e.g. Avastin, Lucentis, Eylea), intravitreal steroids (Kenalog) or sustained release intravitreal implants (Ozurdex, Iluvien).Size comparison of Iluvien to Pencil Tip | Randall Wong, M.D., Retina Specialist, Fairfax, Virginia

Iluvien is Injected Painlessly

Iluvien is injected directly into the vitreous.  The sustained release system will release fluocinolone for 3 years.  The actual “pellet” is small enough to fit inside a 25 gauge needle.  It is smaller and thinner than a grain of rice.  You may click on the image to enlarge.

By injecting directly into the eye, as with all intravitreal injections, only small amounts of drug are needed to treat the retina.

The steroid will chemically stop the retinal vessels, affected by the diabetic retinopathy, from leaking.

36 month Delivery

While intravitreal drug delivery is not novel, the duration of the product is unique.

Constant treatment for 36 months may have huge practical advantages; namely fewer offices visits and less testing.

The economics of this are intriguing.  The practical consequences are even more staggering.  In short, this could mean far fewer trips to the retina specialist for the patient AND the family.  Fewer office visits translates into fewer examinations and testing.

We’ll see.

 

 

 

 

Iluvien Gains Ground

Iluvien Approved in EuropeIluvien continues to make progress outside the US for treatment of macular edema due to diabetic retinopathy.

Iluvien, a sustained release drug delivery system from Alimera Sciences, is a proprietary intraocular injection for the treatment of diabetic macular edema.  Iluvien releases a steroid for up to 36 months and may be a significant treatment for the most common “complication” of diabetic retinopathy.

Normal retinal vessels tend to leak the clear fluid part of blood into the retinal tissue.  If the fluid accumulates in the macula, vision is often decreased.  Treatment is aimed at preventing further accumulation of fluid and thus preventing further loss of vision.  Often the “swelling” can be fixed and vision improves.

Presently, diabetic macular edema is treated with laser, anti-VEGF medicines or steroids.  Unfortunately, treatment for diabetic macular edema is similar to “weeding a garden”…the leakage tends to come back.

Austrian Approval

Iluvien was just approved for use in Austria several weeks ago.  This marks the first sustained release pharmaceutical in that country for the treatment of DME (diabetic macular edema).

United Kingdom Follows Suit

More recently, the United Kingdom allowed marketing authorization for Iluvien, too.  This is the second EU (European Union) country to accept the drug.

Not FDA Approved

Iluvien is not approved for use in the United States.  Most recently, the FDA was not satisfied with the safety data presented by Alimera Sciences, Inc. and recommended additional clinical trials.

What Does This Mean?

Treatment of macular edema from diabetes is difficult and can be frustrating.  Intraocular injections have been a great alternative to the gold standard of laser treatment.

Laser treatment for diabetic macular edema is not appropriate for all patients and alternative treatments are needed.

Ozurdex, a product similar to Iluvien, is FDA approved but not for diabetic macular edema yet has been used “off label.”

 

 

 

 

 

 

Iluvien Marches Forward in Europe

Iluvien advances in the regulatory process for use in the treatment of diabetic macular edema in Europe.

Similar to the FDA process, Alimera announced the “positive outcome of the Decentralized Procedure (DCP)” for use in Europe.  The European process now involves a national phase of the DCP where a panel of countries will need to recommend Iluvien for medical use.

Alimera Sciences’s efforts for FDA approval of Iluvien in the United States were stymied in 2011 citing concerns over safety and requesting additional clinical trials.

Iluvien to Treat Diabetic Macular Edema

One of the more common symptoms of diabetic retinopathy is loss of vision due to swelling in the retina, more specifically, in the macula.  This is called Diabetic Macular Edema (DME).

The macula gives us central vision.   When fluid accumulates within the macula, the vision worsens.

The gold standard for treatment of DME has been laser treatment to the affected areas; however, only the areas next to, but not in, the macula can be treated.  If the macula were treated directly, then permanent blind spots might develop.

This means that not all patients can be treated.  Some patients have diabetic macular edema, but the source of leakage is in the central macula.  These patients can not receive laser treatment.

Alternative include intravitreal injections of steroid or anti-VEGF (such as Avastin or Lucentis).

Iluvien, similar to its cousin Ozurdex (already FDA approved, but for the use of retinal vascular occlusions), is an injectable sustained release device that will release steroid for up to 36 months!  Iluvien has hopes of being the first sustained release delivery system for the treatment of diabetic retinopathy.

What Does this Mean?

I am a big fan of Iluvien.  I like what Iluvien represents.

Iluvien represents an emerging treatment for diabetic macular edema, a disease that clearly needs to be treated in a variety of ways.  Ophthalmologists are limited in our ability to treat these patients as not all patients with this sight threatening complication are candidates for laser treatment.

Iluvien also represents hope for the future, not just for DME, but for sustained release drug delivery.  While the future of Iluvien in the U.S. is beyond my scope, I am glad to see that the technology is still viable…somewhere.

While we may not see Iluvien available here in the US, perhaps its approval and use in another country will be enough for a company such as Alimera Sciences to sustain them as a business and allow them to continue their research and development of newer technologies.

 

Still No Iluvien

FDA Denies Alimera Sciences' Iluvien for Treatment of Diabetic Macular Edema

 

Alimera Sciences fails to get FDA approval for Iluvien.  Iluvien is a sustained release drug delivery system that releases a steroid into the eye for the treatment of diabetic macular edema.  Alimera received the denial late last week in a letter from the FDA.

Implant Too Risky

In short, the FDA still has concerns about the safety of the new drug.  Original concerns about cataract formation and IOP (intraocular pressure) still remain despite additional safety data submission.  The FDA has stipulated additional clinical trials must be performed to answer the risk/benefit concerns.

Iluvien was anticipated to be the second sustained release drug for the treatment of a retinal disease.  The first drug, Ozurdex, was approved by the FDA for treatment of retinal vascular occlusions (e.g. CRVO, BRVO).  Ozurdex received FDA approval in 2009.

Docs Need Options for DME

Iluvien was to be indicated for the treatment of diabetic macular edema, a very common complication of patients with diabetic retinopathy.  Typically, patients receive laser treatment as a first line treatment, but alternative treatments have been long needed as laser can not be performed in everyone.

Intraocular injections of steroid or anti-VEGF medications such as Avastin or Lucentis, have also been used to treat diabetic macular edema over the past several years, but the use of these agents is “off label.”

The sustained release device is injected into the eye and will release a steroid, fluocinolone, for up to 36 months.  Shorter acting steroid injections have demonstrated favorable results and it was anticipated that a sustained release system might offer a realistic benefit of better drug levels and little need for reinjection.

What Does This Mean? Certainly, I am not in a position to remark about the FDA decision. There are many patients in whom laser is not an appropriate treatment.  There is no FDA approved alternative.  Ophthalmologists, including myself, have been using short acting steroids and anti-VEGF injections to treat these “no laser” patients.

Moreover, Iluvien would have validated sustained release drug delivery systems.  Ozurdex was first and Iluvien would have been the second delivery system designed for injection into the vitreous.

A second approved product, regardless of indication, would have been a significant endorsement for injectable sustained release systems.  Sustained release devices for macular degeneration (sustained release drug delivery of anti-VEGF), post-operative medications and glaucoma seem logical.

 

 

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Alimera Sciences Says Iluvien Effective at 3 Years

Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval.  The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year.  The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new drug application.

Iluvien is Effective for Diabetic Macular Edema

Iluvien may be an effective new treatment for diabetic macular edema.  In theory, patients that require treatment for this common complication of diabetic retinopathy may receive an injection of Iluvien.  Iluvien will then release a steroid over several months and the company is trying to prove that it provides a benefit to the patients, in this case, the vision improves.

Such safety and efficacy data were presented recently to the public at a large ophthalmic meeting in FL last month.  The company has also submitted this data to the FDA (Food and Drug Administration).

About 30% or More of Patients Improve with Iluvien

In short, the company performed two large clinical trials, the so-called FAME study showed that about 33% of patients  receiving the implant noted an improvement in vision.  Of significance is that this improvement, according to the company, was present after 3 years.

Last year, the FDA also asked for a review of the manufacturing process of Iluvien, but I am not aware of any specific elements that were made public.  These, too, have been addressed.

What Does This Mean?

About a year ago, Alimera Sciences submitted the new drug application (NDA) for it’s proprietary intraocular drug delivery system for the treatment of diabetic macular edema (DME).

The NDA is the last step to acheiving FDA approval for a new drug.

Last December, the FDA failed to approve the NDA, but, instead requested more data about the efficacy (how well a drug works) of Iluvien.  This was provided this Spring.

So…we continue to wait.  There should be some decision made this Fall, but my guess will be that it is favorable.

If you remember, Ozurdex, the first sustained release intraocular drug delivery system was approved for treatment of retinal edema caused by retinal vascular diseases.

It may be that a second such device may be shortly approved for the treatment of diabetic retinopathy.  While this further endorsed the sustained release technology, it will be a breakthrough that allows significantly more people to be helped that presently have few options.

 

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FDA Denies Iluvien

Iluvien Denied by FDA

The Food and Drug administration fails to approve Iluvien for the treatment of diabetic retinopathy and cites the need for more safety information in addition to concerns about the safety of the manufacturing process of Iluvien.   Alimera Sciences had hoped to gain approval by the end of December 2010, instead, it was told by the FDA that more information was needed.

Safety and Efficacy of Iluvien

Data from almost 1000 patients were included in the FDA submission.  If you remember, Alimera Sciences received a “Priority Review” from the FDA when the application was filed last summer.  A “Priority Review” accelerates this last leg of the FDA approval process.

Instead, the FDA is asking for additional safety/efficacy information covering 36 months after treatment instead of the 24 months provided.

Is Manufacturing Safe?

There were also concerns regarding the manufacturing, packaging and sterilization of Iluvien, though no specifics were noted.

What Does this Mean?

We’ve now heard about Iluvien for diabetic macular edema for over a year.  At the outset, the news has been promising and the technology exciting.  For patients with diabetic macular edema, this drug promises options to the old standby …laser treatment.

Iluvien may be the second drug approved that is based on technology to offer sustained drug delivery into the eye.  Ozurdex, a similar product, has been in use since the summer of 2009 and is used for retinal vein occlusions.

While promising, the FDA plods slowly, yet thoroughly.  The request for additional data indicates that this product is probably effective for treating macular edema, yet recommendations need to be made regarding is use.  Hence, the need for additional dtate.

Had the product been rejected, or requests for additional clinical trials, this would have been a clearer signal of failure.

In the end, though disappointing, the company hopes to have a marketable product by the end of 2011.

Hang in there.

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Iluvien Gets Closer to FDA for Diabetic Retinopathy

Iluvien, an injectable drug delivery system for the treatment of diabetic retinopathy, gets closer to becoming FDA approved.  Alimera Sciences announced this week that the FDA has given the investigational device “Priority Review” status.  Priority Review status hastens the chances of full FDA endorsement from 10 months to 6 months.

What is Iluvien?

Iluvien is a sustained drug delivery system that is injected into the eye, specifically into the vitreous.  Similar to Ozurdex, Iluvien will release steroids into the eye, in this case, up to 3 years.  Alimera Sciences anticipates that this drug delivery system will be approved for treating diabetic macular edema, a very common malady that affects those with diabetic retinopathy.

Current Treatment for Diabetic Retinopathy

This approach is novel in that it will be the first pharmaceutical agent, or medicine, to be FDA approved for diabetic macular edema.  To date, only laser treatment to the retina is approved.

On the other hand, retina specialists like myself, have been using intravitreal injections of Avastin or steroids for several years as an acceptable alternative to laser.

Other Drug Delivery Systems for the Eye

Ozurdex was released just over a year ago (summer 2009) for the treatment of retinal vein occlusions.  Vein occlusions, another type of retinal disease, can cause significant loss of vision.  I have had tremendous results using Ozurdex, especially for patients with branch retinal vein occlusions.

There are several other injectable systems under development, not just for diabetes, but for macular degeneration and other eye diseases as well.

What Does This Mean? This is significant news in several ways.  First, there is a new therapy emerging for the treatment of the most common complication of diabetic retinopathy.  This is a boon for physicians like myself who are tiring of the limits of laser photocoagulation.  This system has the promise of making visual improvements not possible with laser.

There is a revolution just beginning in the management of eye disease.  These injectable drug delivery systems will forever change our ability to treat, not just retinal disease, but eye disease overall.

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Iluvien: New Drug for Diabetic Macular Edema

Iluvien™,  a new drug for the treatment of diabetic macular edema,  draws one step closer to FDA approval.  Alimera Sciences/pSivida announced that Iluvien showed favorable results in two Phase 3 clinical trials.  The company has announced they will file for a New Drug Application (NDA) based on the favorable results.

Iluvien is a Sustained Release Drug Delivery System

Iluvien releases fluocinolone acetonide, a well studied steroid, after injection into the eye. Intraocular injections have become a popular method for treating a variety of retinal disorders including macular degeneration and diabetic macular edema. The injections are performed in an office setting.

The drug will be released for 24-36 months.  The delivery system is based upon the Medidur™ delivery platform.  Medidur is the proprietary delivery system that, when coupled with fluocinolone acetonide, is dubbed Iluvien.  The platform does not dissolve and remains inside the eye.

Results of the Clinical Trials

Basically, the steroid implant improved vision in almost twice as many patients as those treated with placebo.  In addition, 75% of patients required only one application of the device.

New Drug Application is Last Step for FDA Approval

The last step for Iluvien is now to gain the coveted FDA approval.  The last step following Phase 3 clinical trials is for Alimera Sciences (licensee of Iluvien from manufacturer pSivida) to file a New Drug Application.  It expects to file by the end of the 2nd quarter of this year.

Remember Ozurdex?

Ozurdex™ received FDA approval last summer for the treatment of retinal vein occlusions; branch retinal vein occlusion and central retinal vein occlusion.  Like Iluvien, Ozurdex releases steroid over a period of months.  The major difference between the two technologies is the specific type of steroid (Ozurdex releases dexamethasone), duration of release and the FDA guidelines for use.

Iluvien is most likely going to be the first drug FDA approved for the treatment of diabetic macular edema, whereas, Ozurdex is the first for treatment of retinal vein occlusions.

What Does This Mean? One year ago, sustained release drug delivery did not technically exist in ophthalmology.  By this summer, there may be a second delivery system for treatment of retinal disease.  Clearly the tide is turning in terms of the way we can treat eye disease.

It is quite likely that other drugs will follow…we are anxiously awaiting the first sustained release system for macular degeneration.

I believe that sustained release technology will evolve to treat other eye diseases as well, not just retinal disease.  For instance, what if there were no longer eye drops needed for glaucoma?

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2010: "Year of the…Drug Delivery System?"

2010 may be the year of drug delivery systemsIcon Bioscience, Inc., (IBI) has announced their initiation of Phase 2 and Phase 3 clinical trials for an injectable sustained release system for the use in cataract surgery.  Their product, under the code name IBI-10090, will release anti-inflammatory drug for 2-3 weeks after cataract surgery.  It is hoped that this will obviate the need for the standard anti-inflammatory drops used following cataract surgery.

Similar products, namely Ozurdex™ (Allergan), Iluvien® (Alimera) and I-vation™ (Surmodics) are also sustained release platforms, but all focused on the treatment of diabetic retinopathy or macular degeneration.

Ozurdex has already been FDA approved (and thus, available to the public) for the treatment of retinal vein occlusions.  It is a sustained release system that releases a steroid, dexamethasone, to reduce macular swelling/edema following retinal vein occlusions.  I suspect it will have “off-label” uses for both diabetic macular edema and wet macular degeneration.

Iluvien also releases a steroid.  The steroid, fluocinolone, will be released for the treatment of diabetic macular edema. Their Phase 3 clinical trial should be ending soon and will be awaiting FDA approval.

Surmodics is hopeful that their I-vation system can be used to treat macular degeneration.  Previously, I wrote about their hopes to combine the I-vation delivery system with Lucentis for the treatment of wet macular degeneration.  This should, at the very least, reduce the number of intravitreal injections.  It is also testing a product that releases steroid for diabetic retinopathy.

What Does This Mean? IBI is the latest to enter the sustained release market for ophthalmic drug delivery.  There are now at least 4 companies focused (no pun intended) on extended release technology for the eye.  It is the technology that is most exciting.

All of these delivery systems are expected to be versatile.  They should be able to “carry” or deliver any number of different drugs depending upon the intended disease to be treated. For instance, while Ozurdex presently carries a steroid, it could easily carry (Novadur is the actual name for Allergan’s delivery technology) anti-VEGF drugs, etc.

While IBI is entering the market with a system for post-surgical cataract treatment, a similar product is in the IBI pipeline for the treatment of retinal diseases, such as diabetic retinopathy and macular degeneration.

“Randy”

Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
Fairfax Virginia

Iluvien® For Diabetic Macular Edema Has Eyes on FDA

™Alimera Sciences’ “Iluvien®” moves closer to FDA approval for the treatment of diabetic macular edema.  Iluvien is an extended release drug delivery system designed for direct intravitreal injection to the eye.  Iluvien will release a steroid, fluocinolone acetonide, for up to 36 months to treat retinal swelling.  The company has announced pivotal results in the ongoing FAME (Fluocinolone acetonide in diabetic macular edema) study.  This is a phase 3 FDA clinical trial.

An earlier post covered Iluvien’s safety and efficacy in phase 2 trials for the treatment of diabetic macular edema.

Diabetic Macular Edema is the most common complication of diabetic retinopathy.  The traditional laser for diabetic retinopathy has been usual treatment for about 30 years.  I have written previously about the emergence of new treatments and new technologies to treat the diabetic macular edema.  Intravitreal steroid injections, anti-VEGF and sustained release intraocular drug delivery systems are all the rage.

FDA Clinical Trials dictate how medicines are approved for treatment of disease in the U.S.  I have always cautioned that you must consider a “treatment” only if it has already been FDA approved.  Most of what is advertised as treatment is neither FDA approved nor even studied.

There are 4 different steps to passing the FDA requirements. There are 3 phases of clinical trials (sometimes an additional phase 4 is required) and the NDA (New Drug Application).

The phase 3 clinical trial (FAME) is almost complete.  The study will proceed to 36 months.  The early phase 3 findings indicate improvement in vision in about 25-30% of patients after the first 24 months of the study.

What Does This Mean? This is huge.  It means that there is merit to what the company anticipates.  Technically, phase III trials determine if the drug is useful and confirms safety.

New Drug Application (NDA) is usually the last step for a company, or sponsor, to be allowed to market and sell the drug.  Alimera expects NDA submission later in 2010 after completion and analysis of the phase 3 data.

Alimera’s Iluvien is close to reality for the treatment of diabetic macular edema.

For fun, compare the status of this drug, Iluvien, to E10030.  I wrote about Ophthotech’s E10030 a few days ago.  E10030 is an anti-PDGF aptamer that treats wet macular degeneration.  This drug is about to enter phase 2.

“Randy”

Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
Fairfax Virginia

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Currently, I see patients with retinal diseases; macular degeneration, retinal detachment, macular holes, macular pucker within several different practices.....it's a different arrangement, but it allows more continuous care with many eye specialists. In addition, I am very accessible via the web. To schedule your own appointment, call any of the numbers below.

Capital Eye Consultants
Randall V. Wong, M.D.
Contact: Brigitte O’Brien

A: 3025 Hamaker Court, Suite 101 • Fairfax, Virginia 22031
Ph: 703.876.9630
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Dressler Ophthalmology Associates, PLC
Randall V. Wong, M.D.
Contact: Andrea Armstrong (Surgery/Web)
Chrissy Megargee (Web)

A: 3930 Pender Drive, Suite 10 • Fairfax, Virginia 22030
Ph: 703.273.2398
F: 703.273.0239
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