Edema and Related Medical Conditions

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Friday, March 24, 2006

Retisert and Macular Edema

Retisert - fluocinolone ophthalmic (flu nis O lone Opt hal mick)

What is the most important information I should know about Retisert?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

What is Retisert?

Fluocinolone is in a class of drugs called corticosteroids. It inhibits processes in the body that cause inflammation. Therefore, the swelling and pain of inflammatory conditions is decreased.

Retisert is used to treat eye inflammation caused by infections, injury, surgery, or other conditions.

Retisert may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before using Retisert?

It is not known whether Retisert will harm an unborn baby Do not use Retisert without first talking to your doctor if you are pregnant.

It is also not known whether Retisert passes into breast milk. Do not use Retisert without first talking to your doctor if you are breast-feeding a baby.

How should I use Retisert?

Use Retisert eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

What happens if I miss a dose?

Talk to your doctor if a dose has been missed.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, call an emergency room or poison control center near you. If the drops have been ingested, call an emergency center for advice.

What should I avoid while using Retisert?

Use caution when driving, operating machinery, or performing other hazardous activities. Retisert may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with Retisert.

What are the possible side effects of Retisert?

Serious side effects are not expected with this medication. Rarely, an increase in the pressure inside of the eye, formation of cataracts, or perforation of the cornea have been reported. Talk to your doctor about any possible side effects.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision or sensitivity to light may occur. Continue to use Retisert and talk to your doctor about any side effects that you experience.

What other drugs will affect Retisert?

Do not use other eyedrops or eye medications during treatment with Retisert without first talking to your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylfluocinolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

Drugs other than those listed here may also interact with Retisert. Talk to your doctor or pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about Retisert written for health professionals that you may read.



See also: Retisert


Diabetic Macular Edema trial with Retisert(TM); Positive Results for pSivida

2/21/2006 8:00:00 AM EST

Global bio-nanotech company pSivida Limited (NASDAQ:PSDV)(ASX:PSD)(Xetra:PSI) today announced the publication of preliminary three year follow-up data from Bausch and Lomb's multi-center, randomized, controlled clinical trial of Retisert(TM) for the treatment of diabetic macular edema (DME). Global eye health company, Bausch and Lomb (NYSE:BOL), exclusive licensee of Retisert(TM) from pSivida, conducted the study in hospitals in the United States in which 197 patients were randomized to receive either standard of care (repeat laser or observation) or a Retisert(TM) implant. The study concluded that significantly more patients receiving a Retisert(TM) implant had improved visual acuity (of three or more lines on an eye chart) than those receiving standard of care.

DME, a common complication of Diabetic Retinopathy (DR), is the leading cause of vision loss in people under the age of 65 in the United States with an estimated 500,000 treatable cases. DME is characterized by swelling of the retina and loss of vision. Currently the only FDA approved treatment is laser therapy in which holes are burned into the macula with a laser. This treatment is often ineffective or generally provides only temporary benefit. There are no approved drug therapies for the treatment of either DME or DR. Retisert(TM) for DME is surgically implanted into the eye and releases a constant amount of the drug, fluocinolone acetonide. Retisert(TM) is FDA approved for the treatment of posterior uveitis with a duration of 30 months and is licensed to Bausch & Lomb and co-promoted by Novartis.

Medidur(TM) is pSivida's next generation product. It is a tiny, injectable device that can release the same drug as Retisert(TM). Unlike Retisert(TM), which is surgically implanted, Medidur(TM) is injected into the eye during an office visit. Medidur(TM) is in Phase III clinical trials in DME in collaboration with Alimera Sciences Inc., a specialty pharmaceutical company focused on the ophthalmic industry.

"As Retisert(TM) and Medidur(TM) can deliver the same drug, at a similar rate, to the back of the eye, we hope the Medidur(TM) trials in DME show a very similar improvement in visual acuity to that shown in the Retisert(TM) DME trial. Medidur(TM) differs from Retisert(TM) in that it is a smaller device that can be inserted without the need for surgery," said Mr Gavin Rezos, CEO of pSivida Limited.

Results of the Bausch & Lomb study has shown that a statistically significant number of eyes treated with Retisert(TM) had an improvement of visual acuity of three or more lines on an eye chart compared to eyes receiving standard of care (28% versus 15%, p less than 0.05). Additionally, a statistically significant number of eyes treated with Retisert(TM) showed an improvement in their diabetic retinopathy severity score, a measure of the severity of their disease (13% versus 4% p less than 0.001). More eyes receiving Retisert(TM) also showed a reduction in their edema and there was also no evidence of edema in 58% of eyes receiving the implant versus 30% of eyes receiving standard of care (p less than 0.001).

Side-effects of Retisert(TM) in patients with DME were similar to those reported in patients with uveitis for which Retisert(TM) is approved. Of the patients with DME receiving Retisert(TM), at three years 33% required an operation to relieve elevated intraocular pressure (IOP) and 95% required cataract surgery. Cataract surgery is a relatively uncomplicated and established procedure with a high success rate. The abstract (#5442) detailing the DME data is available on the website of the Association for Research in Vision and Ophthalmology www.arvo.org. The three year uveitis data is available at the same website (abstract #1523). Fuller data will be presented at the ARVO conference in May 2006.

pSivida receives royalties from sales of Retisert(TM) for chronic non-infectious posterior segment uveitis, a sight threatening condition that affects an estimated 175,000 people in the United States and an estimated 800,000 people worldwide. The product is presently priced at US$18,250 and is approved as a 30 month treatment. Covered in the United States by Medicare and Medicaid, Retisert(TM) is co-marketed in the United States by Bausch & Lomb and Novartis. In the event that Retisert(TM) is approved for DME and Bausch & Lomb decide to market Retisert(TM) for DME, then pSivida will receive royalty payments from Bausch & Lomb for Retisert(TM) sales for DME.



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