Call Us: 703.273.2398

Tag Archives: alimera sciences

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.



Enhanced by Zemanta

October is the AAO Meeting

We are leaving for Orlando, FL in a few days to attend the American Academy of Ophthalmology meeting.  It is our industry’s largest meeting of the year…worldwide.

The meeting has become so large that only a certain cities can host the event;  Atlanta, Dallas, Chicago, San Francisco, Las Vegas, New Orleans and Orlando.  Literally tens of thousands of people will attend;  doctors, administrators, technicians, vendors, etc.

This will be the largest collection of eye related people anywhere in the world.

New scientific discoveries will be announced, new products for patients will be displayed, advanced technology will be highlighted, and hundreds of courses will offered. It’s a huge showcase for anyone related to “eyes.”

We, too, are going to launch MME.

Iluvien Has New Data for the FDA

It is anticipated that Alimera will announce successful completion and submission of some long-awaited data to the FDA.

Alimera Sciences has been trying to obtain FDA approval for a sustained intraocular drug delivery system called Iluvien.  This is similar to Ozurdex (Ozurdex is used for the treatment of retinal swelling due to vein occlusions).

Iluvien will release steroids inside the eye for a period of months to control diabetic macular edema.  It is anticipated that this last bit of data will satisfy the FDA and prove that it is indeed safe and effective.

Stay tuned.

Treatment of Macular Degeneration

I don’t think there will be any earth shattering news in this field. VEGF-Trap Eye is probably going to get some press as this is another drug that promises to be quite effective in the treatment of wet macular degeneration.

VEGF-Trap Eye, or afilbercept, is a compound similar to Avastin and Lucentis, but may need to be injected less often than the aforementioned.

Medical Marketing Enterprises

This is our baby.  Amy and I are very excited.  We will be teaching no fewer than 4 courses on medical marketing using websites, blogs, SEO and social media.  There are only about 10 courses offered in total!

I have been invited to address the “Young Ophthalmologists” about marketing.  This group is comprised of young doctors who are still in training (aka residents, fellows) or those who have been in medical practice fewer than five years.

What Does this Mean? I’ll be wearing several hats this time.  I’ll be wandering the floors and attending lectures to learn more about being a retinal specialist.

On the other hand (or under another hat), Amy and I’ll be teaching other doctors how they, too, should create websites such as this to enhance patient education, improve the Internet, and provide marketing solutions.


Enhanced by Zemanta

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.


Enhanced by Zemanta

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.

Enhanced by Zemanta

Intraocular Drug Delivery Systems Gaining Momentum

The era of intraocular drug delivery has started.  A year ago, Allergan began shipping Ozurdex to the private sector.  As with most of these “injections,”  Ozurdex is injected into the vitreous cavity.  Ozurdex releases the steroid dexamethasone for 4-6 months.

Ozurdex for Retinal Vein Occlusions and Uveitis

The mainstay of treatment for retinal vein occlusions has been laser photocoagulation.  This sustained release drug delivery system is an alternative to laser photocoagulation.  While intravitreal injections of steroid, for example, Kenalog or Triesence, have been very successful in the past in treating the macular edema created by the RVO, I have had tremendous success using Ozurdex to treat branch or central vein occlusions.  In many cases, the results of Ozurdex are superior to laser treatment.

As of September, 2010, Ozurdex is now indicated for uveitis.

Ozurdex is given as an injection in the office setting.  I like to offer pre-operative antibiotics to, theoretically, reduce the chance of infection.  I suggest a regimen of 4x/day for 4 days before and after the procedure.  The chance of infection is comparable to that of cataract surgery.  The device is injected through a thin needle.  The needle is small enough to “seal,” or prevent leakage, without the need for sutures.

The device releases dexamethasone for several months and then dissolves.

Iluvien for Diabetic Retinopathy Nears FDA Approval

Iluvien also releases a steroid, fluocinolone.  It is marketed by Alimera Sciences and is similar to Ozurdex.  Currently, Alimera Sciences has applied for NDA (New Drug Approval) status from the FDA.

The short story, this may become available by the end of the year for the treatment of diabetic macular edema.  It, too, may be a very promising alternative to laser treatment for macular swelling due to diabetes.  Results from clinical trials indicate that Iluvien may be superior to the traditional laser treatment.

Iluvien will be injected into the vitreous the same way as Avastin or Ozurdex.  The device will reside in the vitreous and release fluocinolone, another steroid, to treat swelling due to diabetic retinopathy.

The device does not self-absorb.

Off-Label Indications

So many drugs we use routinely are used “off-label.”  This may be true for both Ozurdex and Iluvien.  It is an exciting time.

Ozurdex, while approved only for RVO, has the potential to be used for say, diabetic retinopathy, too.  This would be an “off-label” use and is certainly a legitimate use of the drug, especially if it becomes “standard of care.”

As an example, Avastin is FDA approved for certain types of cancer, but it has become standard of care for the treatment of wet macular degeneration.

Other Drug Delivery Systems in the Pipeline

  • Icon Biosciences – using the Verisome platform, this injectable “liquid” may release drug up to a year.
  • Regeneron – VEGF-Trap Eye will inhibit VEGF for the treatment of AMD, but also has potential appications for vein occlusions and DME.
  • Several other “players” include:  Genentech, MacuClear, Neurotech, Novagali,

What Does This Mean?  I didn’t try to make this an overhaul of the new devices available.  Instead, I am more interested in sparking interest in a new wave of drug delivery, that is, sustained release drug delivery to the eye.

The concepts are now well established.  Inject something directly into the eye where you expect the most effect.  This obviates the blood brain barrier.  Intraocular injections over the past few years have demonstrated the advantages of directly delivering the drugs to the target tissue.  We have found that even “old” drugs, e.g. triamcinolone, can have impressive results just by delivering the drug accurately.

The next generation of sustained release systems will include drugs such as Lucentis or Avastin.  Any drug now that requires repeated applications (i.e. injections) may have a future with sustained release technology.

It is appropriate to believe that the next level of therapeutics will include any condition which requires chronic therapy.  For instance, glaucoma medications may be combined with sustained release delivery systems.

Imagine, glaucoma treatment becomes managed by a retina specialist.  Now who would have thought?

Enhanced by Zemanta

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.

Enhanced by Zemanta

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.


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

Reblog this post [with Zemanta]

Company Hopes Injectable Implant Cures Diabetic Macular Edema

Alimera Sciences hopes that its Iluvien ™ insert will be effective against diabetic macular edema.  Iluvien™ will release a steroid called fluocinalone acetonide (FA) after insertion into the eye.  The Iluvien™ system will deliver the steroid for up to 3 years.  It is anticipated that intraocular steroid release may control macular edema and improve vision.  The company has a study underway to determine just how effective this intraocular, sustained release drug system for the treatment of diabetic macular edema can be.

Alimera Sciences’ web site.

Is this new? Well, yes and no.  The technology is new.  A small implant will be injected into the eye.  The device will release a small amount of steroid into the vitreous for up to 36 months.  The injection site will be very small and will not require any stitches to close.  The entry point will be so small that it will self-seal.

“Old Drug – New Tricks” The drug, fluocinolone acetonide (FA), is not new.  It is an old, well studied, steroid.  Topical steroid drops, oral steroids and even intravenous steroids (IV) do not get into the eye very easily.  In order to get enough drug into the eye via these methods, the doses required become quite high, thereby increasing the likelihood of systemic toxicity.  Ideally, the direct insertion of the drug to its target tissue (the retina) will be more effective in treating macular swelling due to diabetic retinpathy (aka diabetic macular edema) than present treatments.  To state another way, by simply changing the route by which a drug is delivered (in this case directly into the eye versus, say, eye drops), the drug becomes more effective.

This is not really new news. If you have been reading carefully over the past year, steroids have been very useful for the treatment of macular swelling, not only in patients with diabetes, but also in cases of macular degeneration, retinal vein occlusions, etc.  Intraocular injections of steroids, such as triamcinalone acetonide (TA), have been widely used by retinal surgeons for the past 5 – 10 years, but they often need to be repeated.  A sustained release delivery system is needed (give an injection once, and it lasts for years).  So, using steroids to treat retinal swelling just makes sense.

Ozurdex® received FDA approval in June 2009. Allergan, Inc., just released its new steroid releasing implant.  Ozurdex® is an injectable sustained release system that was FDA approved in June of this year.  It is now available for patient use.  Ozurdex® also releases steroid inside the eye for up to 6 months.  The system then safely dissolves.  This system was FDA approved for the treatment of retinal swelling (aka macular edema) caused by retinal vein occlusions.  I predict that it will soon be used, off-label, for the treatment of diabetic macular edema.  Read my previous post regarding Ozurdex®.

This is all good news. To date, the Ozurdex® and Iluvien™ implants both validate the effectiveness of intraocular steroids for the treatment of diabetic macular edema.  Both are intravitreal, long term release systems.  They are small and can be delivered safely in an office.  It is exciting that new treatments, using well-studied medicines, are now available for treating such a prevalent complication of diabetic retinopathy.

Lastly, the advantages of sustained released systems can not be understated.  While it may sound a little aggressive to be injecting medicine directly into the eye, it is proving to be very effective in treating many eye diseases such as macular degeneration.

Intraocular injections have two major advantages, it delivers drug right where you want it and it takes lower doses than otherwise would be needed if given orally or by intravenous.  Therefore, little chance of side effects to the rest of the body!  The drug works at lower levels because it is injected right where it is needed.  It also may reduce the number of office visits (i.e. costs) and also increases “compliance,” that is, there is no question the patient is taking his/her “medicine.”


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

Reblog this post [with Zemanta]


Currently, I see patients with retinal diseases; macular degeneration, retinal detachment, macular holes, macular pucker within several different'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.

Virginia Lasik | Office of Anh Nguyen, M.D.
Randall V. Wong, M.D.
Contact: Layla

A: 431 Park Avenue, Suite 103 • Falls Church, Virginia 22046
Ph: 703.534. 4393
View Map

Dressler Ophthalmology Associates, PLC
Randall V. Wong, M.D.
Contact: Ashley (Surgery/Web)
Chrissy Megargee (Web)

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