Alice Goodman

November 25, 2013

NEW ORLEANS — A sustained-release travoprost plug, which is inserted under the eyelid, is safe and effective for lowering intraocular pressure in patients with glaucoma or ocular hypertension, a preliminary study has found.

The reduction in intraocular pressure was comparable to that seen with topical brand-name prostaglandin analog eyedrops, and the plug was easy to insert and well tolerated by patients.

"In glaucoma, our biggest enemy is compliance. Many patients are asymptomatic so are not motivated to use their eyedrops," explained lead investigator Robert Noecker, MD, from Ophthalmic Consultants of Connecticut in Fairfield. "Over 2 months, the eye-plug delivery system for travoprost was safe and lowered pressure by more than 20%. With this system, the patient does nothing for 2 months and remains comfortable."

This research was singled out for a poster tour here at the American Academy of Ophthalmology 2013 Annual Meeting.

"Physicians who check their nursing home patients once a week are not able to verify that older and senile patients are taking their eyedrops for glaucoma or ocular hypertension," explained tour leader Paul Palmberg, MD, from the Bascom Palmer Eye Institute in Miami. "This travoprost eye plug ensures that the drug is being delivered, and it does not cause excessive tearing."

Dr. Noecker noted that the reduction in intraocular pressure seen with the eye plug is in the same range as that obtained with 1 drop of prostaglandin analog per day.

It is understood that 1 drop of prostaglandin analog per day works better than 2. "You don't want to overdose your patients," he noted.

In glaucoma, our biggest enemy is compliance. Many patients are asymptomatic so are not motivated to use their eyedrops.

"The success with the eye plug may be due to its swelling once it is placed. No overdosing occurs here. Overdosing is the enemy with glaucoma," Dr. Palmberg added.

The pilot study involved 20 patients and 36 eyes at 2 sites in South Africa. Patients were followed for 60 days.

The active drug in the eye plug is encased in microspheres, which disappear over time. At the beginning of the study, the eye plug was placed under either the upper or lower eyelid. However, Dr. Noecker noted that, with experience, he has found that access is easier when it is placed under the lower eyelid.

At baseline, average morning intraocular pressure was 28.7 mm Hg. At 60 days, the mean reduction in pressure was 6.7 mm Hg (23.5%). After 60 days, the eye plug system was flushed out of the eyelid.

Some patients experienced irritation in the eyelid but, overall, the safety was reassuring.

"The challenge in treating glaucoma is that it is a chronic disease that needs to be dosed daily," said Andrew Iwach, MD, from the Glaucoma Center of San Francisco. "There is a lot of interest in trying to design a delivery system that is more convenient for patients. This is an excellent study showing that by placing a plug in the eyelid, the device releases medication slowly over time."

"This study shows that the eye plug is effective, and it opens the possibility that there are other molecules out there that we could use. The sustained delivery system overcomes the challenge of avoiding peaks and troughs of drug levels," Dr. Iwach told Medical Medscape News.

"These data are exciting because they show that a different delivery mechanism is available for drugs that are already approved by the FDA. This delivery system is convenient, will help with compliance and, therefore, achieve better intraocular pressure control," he said.

This study was supported by Ocular Therapeutix. Dr. Noecker is a consultant for the company. Dr. Palmberg serves as a consultant for Abbott Medical Optics, Aeron Astron, Europe, AqueSys, Aurolab, and Innovia. Dr. Iwach has financial relationships with Acumens, Alcon Laboratories, Carl Zeiss Meditec, IRIDEX, Lumenis, and Merck.

American Academy of Ophthalmology (AAO) 2013 Annual Meeting. Presented November 17, 2013.


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