Tag: alimera sciences

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Diabetic retinopathy Treatments

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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How I Practice My Opinion

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.

 

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Diabetic retinopathy Treatments

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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Diabetic retinopathy Treatments

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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