More AAO Highlights: Steroid implants for DME, Gene Therapy for Retinal Dystrophy, and More

November 11, 2009

The following excerpts are taken from the Academy Live emails sent out to AAO members during the meetings.

Here are the highlights:

October 25, 2009

Diabetic macular edema: Steroid implants start to deliver the goods

At yesterday’s (October 24th) Retina Subspecialty Day, Baruch D. Kuppermann, MD, PhD, provided a sneak peek at the reservoir and biodegradable steroid implants that may soon play a role in ocular drug delivery for diabetic macular edema (DME).

Already FDA-approved for uveitis, Bausch & Lomb’s fluocinolone acetonide (Retisert) implant—sutured to the sclera where it can last up to 1,000 days—has also been tested for DME. Clinical trial results showed visual acuity gain, macular edema resolution, and diabetic retinopathy stabilization, said Dr. Kuppermann. But concerns over side effects of cataract and glaucoma led the company not to file for FDA approval for DME.

Alimera Sciences’ Iluvien fluocinolone acetonide reservoir implant contains half as much drug to reduce the side effects seen with Retisert. The Iluvien implant is injected with a 25-gauge needle and floats in the vitreous cavity. Once empty, the nonbiodegradable polymer husk remains in place. Results of the phase 3 FAME trial for DME could be out by the end of this year.

Releasing triamcinolone, SurModics’ I-vation has a corkscrew design that increases the surface area for drug delivery. Screwed into the eye, the implant anchors to the sclera. At 36 months, the phase 1 study has shown macular edema reduction but also cataracts.

Called Ozurdex in the United States and Posurdex elsewhere, Allergan’s dexamethasone drug-delivery system is an injectable biodegradable copolymer implant approved by the FDA in June 2009 for persistent macular edema due to vein occlusion. In phase 2 trials involving DME patients, 35 percent of eyes receiving 700 micrograms improved 10 letters or more by Day 90, compared with 24 percent of those receiving 350 micrograms, and 13 percent in the observation group.

Dr. Kuppermann receives grant support from Alimera Sciences, is a consultant for SurModics and is a consultant and lecturer for Allergan and receives grant support from Allergan.

October 26, 2009

Gene therapy improves vision in patients with severe retinal dystrophy

Jean Bennett, MD, PhD, presented an update on her team’s ongoing development of gene therapy for Leber’s congenital amaurosis. Phase 1 study results for the treatment, the first gene therapy for a nonlethal pediatric disease and for inherited retinal degeneration in adults, were published in the Oct. 24 issue of The Lancet.

A rare autosomal recessive disease with early onset and that causes incurable retinal degeneration, Leber’s congenital amaurosis is often caused by mutations in the RPE65 gene, which is produced in the retinal pigment epithelium, where it helps to generate a vitamin A compound essential for vision. Dr. Bennett and her colleagues have developed a method to deliver a normal version of the RPE65 gene via a subretinal injection of a genetically engineered adeno-associated virus. Twelve patients ranging in age from 8 to 44 were treated in their worse eye in the phase 1 study.

Children responded best to treatment, Dr. Bennett reported, with all of them gaining ambulatory vision. Some patients improved to the extent of no longer being classified as legally blind. In addition, the pupillary light reflex was restored in eyes that were barely responsive before treatment. All patients demonstrated at least a 2-log unit response, and the subjects’ visual fields expanded. Dr. Bennett showed video of the youngest patient successfully completing an obstacle course in the laboratory using his treated eye three months after treatment, but he was unable to complete the course using only his untreated eye. The treatment appears safe and well-tolerated. A phase 3 study of the treatment is scheduled to begin in February.

Dr. Bennett reports no relevant financial disclosures.

Genetics may influence response to ranibizumab in wet AMD patients

A study conducted by Genentech researchers suggests that genetic polymorphisms may influence ranibizumab (Lucentis) treatment outcomes in wet AMD patients. These results, if validated by further research, could help determine future population selection for clinical trials, said Jason Ehrlich, MD, who presented the study results.

The research involved a genome-wide association study on 352 ranibizumab clinical trial subjects. The investigators identified multiple single nucleotide polymorphisms associated with significant differences in mean visual acuity change after 12 months of ranibizumab treatment. Visual acuity gains were smaller in patients with fewer of the beneficial SNPs, Dr. Ehrlich said.

For his presentation, Dr. Ehrlich accepted a Best Paper award at yesterday morning’s Retina Paper session.

Dr. Ehrlich is an employee of Genentech.

Tips for adding premium IOLs to your practice

Kerry D. Solomon, MD, offered advice on strategies for incorporating premium IOLs into a medical practice and introducing the high-technology IOLs to patients.

Here are some of his recommendations:

* Speak slowly and clearly.
* Sit lower than patients and look them in the eye.
* Have a family member present in the room.
* Provide balanced information.
* Remember that you are an educator, not a salesperson.
* Ask patients if they would prefer to perform more of their daily activities without glasses and provide examples of such activities.
* Don’t introduce too much new information during an office visit. If necessary, mail additional information to a patient’s home or make it available on a Web site.
* Make your own recommendations to patients regarding the best treatment for them.
* Make sure your office staff and technicians are knowledgeable about premium IOLs.
* Listen to your staff’s intuition.
* Make sure your patients are educated about their options. Provide enough information for patients to make decisions.
* Ask patients, “Have I answered all of your questions?” and “What can my staff do for you?”
* It’s not about improving your bottom line but about improving your treatment of patients.

Dr. Solomon is a consultant and speaker for AMO, Alcon and Bausch & Lomb, and he receives grant support from AMO and Alcon.




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