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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?

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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.


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

Steroids Likely to Help Diabetes

Ok, maybe a bit dramatic, but another article was recently published stating that intravitreal injections were used with success to treat diabetic macular edema.   These effects lasted at least 5 years, the duration of the study.

This was a small study where two groups were compared.  One group received intravitreal injections of triamcinalone (a steroid) for the treatment of diabetic macular edema.  The second group received a placebo.

After two years, the second group then started receiving the steroid.  The first group continued.  Occasionally, laser was used in either group.

The results were that vision improved and swelling decreased in the first group.  In the second group, the vision improved and swelling decreased, but only after receiving the steroids.

What Does This Mean? The other day, I reviewed a small study (Eye Injections Challenge Eye Laser for Diabetic Retinopathy) and had a few criticisms.  This study, too, has the same pitfalls.  Don’t take away that all small studies are worthless, they are not.

A few months ago, there was some discussion regarding a couple of emerging new drug delivery systems available for ophthalmic use.  Iluvien® (Alimera) is an injectable sustained release system that will release steroid (fluocinalone) for the treatment of diabetic macular edema.  Clinical trials are underway.

Ozurdex™ (Allergan) is the first sustained drug delivery system to hit the market.  It was approved last June 2009 by the FDA for treatment of macular edema caused by retinal vein occlusions.  Though not approved directly for the treatment of macular edema found in diabetic retinopathy, my prediction is that it will be used “off-label” in the near future.

I think, slowly, we are moving to the point where intravitreal injections are going to replace laser therapy for the treatment of diabetic macular edema.  I am using the term “injections” rather loosely as I also am including the use of sustained release systems.  These, too, will be delivered by an injection method, similar to intraocular injections.  The only difference is that the sustained release systems will deliver the pharmaceutical over a much longer period, thus, requiring fewer “treatments.”

The full article is referenced here;  Ophthalmology. 2009;116(11):2182-2187.  There is no link as viewing may require a subscription.


Randall V. Wong, M.D.

Ophthalmologist, Retina Specialist
Fairfax, Virginia

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SurModics' Drug Delivery to Release Lucentis for Macular Degeneration

In a press release this week, Surmodics, Inc., announced its agreement with Roche and Genentech, manufactureres of Lucentis® (ranibizumab), to develop a sustained release drug delivery system for the treatment of wet macular degeneration.

Surmodics has a drug delivery system based upon biodegradable microparticles that may potentially reduce the annual number injections of Lucentis® a patient receives for macular degeneration.  The company has a 30 years history of drug delivery through microparticles, implants and coatings.

Right now, testing through the FDA is still in its infancy.  Wait to hear more about this product after in enter phase 3 clinical trials.  It is estimated that this will still be 3-5 years away.

What does this mean? Yet another sustained drug delivery system is in the works. Intraocular drug delivery systems are just emerging and the socio-economic impact will be dramatic.  This may join the ranks of Alimera (Iluvien™) and Allergan (Ozurdex®).  In the case of Lucentis®, fewer intraocular injections mean fewer procedures, possibly fewer trips to the doctor’s office, less “time-off” for medical appointment for both patient and family, and ………….perhaps better treatment results due to longer exposure to medicines via sustained release mechanisms.


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

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Intraocular Drug Delivery – It's About Timing

Ok, maybe a little pun in the title.

Yesterday, I wrote about Alimera’s study using Iluvien™ for the treatment of diabetic macular edema.  As we have been commonly using intraocular steroid injections to treat this condition (see previous posts under “treatments”), it only makes sense that there are now products (Ozurdex/Allergan and Iluvien/Alimera) that have been designed for long-term release of steroids when injected into the eye.

Ten years ago, the notion of injecting medicines directly into the eye on a regular basis were somewhat far-reaching.  There were some treatments for AIDS eye disease (CMV retinitis) that required repeated and frequent eye injections, but the risks (of the injections) were low.  There was no other therapy.  Intravenous and oral medications just didn’t work.  If no shot were given, then the patient could go blind….in a matter of a few weeks.  (As a matter of fact, an intraocular device did become available for continuous release, but there were significant drawbacks.)

The “timing” is perfect for these injectable intraocular drug delivery systems. Intravitreal injections are now common place.  There is no more hesitation.  These eye injections are routinely given in a retina specialists office.  The injections use very thin needles.  Since the insertion site is so small, surgery is avoided as these entry sites seal by themselves.  We have discussed the merits of intraocular injections before; Lucentis®, Macugen®, Avastin®, and steroids.

The “timing” is perfect for sustained release intraocular drug delivery systems. In cases of macular degeneration, the treatments need to be repeated and can be as frequent as once a month.  These monthly injections may need to be given for over a year.

Wouldn’t it be great if we could………..some day, have sustained intraocular drug delivery systems that were releasing anti-macular degeneration drugs?  Actually, that day may be just around the corner.


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

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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

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Steroid Implant May Reduce Diabetic Retinal Edema

In June, the FDA approved a new intraocular device for the treatment of so-called retinal vein occlusions. In this disease, the whole or partial venous tree of the retina becomes occluded. Secondary swelling of the macula occurs thereby reducing vision. Current therapy involves only laser treatment.

This new drug delivery system, marketed by Allergan Pharmaceuticals, will be available later this year.  It will involve an in-office injection of the small device right into the eye.  Dexamethasone, a well studied steroid, will be released for about 6-9 months.  The system, itself, will biodegrade as the drug is released.

The Ozurdex® system was noted to improve vision in up to 30% of patients suffering from RVO.

What does this have to do with diabetic retinopathy? There has been evidence over the past few years that direct injection of steroids was beneficial to patients with RVO.  Similarly, there is evidence that steroids also may improve diabetic macular edema AND age related macular degeneration.  Doctors, like myself, have been injecting steroids for these entities for several years, using the medications “off-label.”  Don’t worry, using medications off-label is legit.  In the end, this steroid implant may be a very useful tool to combating macular edema in diabetics!  It is just around the corner!


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

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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.

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