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Article by Larry Haimovitch
The first annual "New Horizons Forum," sponsored by the nonprofit organization Glaucoma Research Foundation (GRF) was held in San Francisco on February 3rd, and by any measures, was a tremendous success.
GRF, founded in 1978 by three glaucoma specialists, is a national nonprofit organization that funds glaucoma research worldwide.
The New Horizons Forum was designed as a platform for collaboration of worldwide leaders in medicine, science, business, venture capital and philanthropy. It is a forum to share the latest thinking and ideas for dealing with glaucoma, which because of its symptom-less nature, has often been described as a "silent thief of sight."
In an outstanding keynote address, George Cioffi, MD, who recently joined the Harkness Institute, Columbia Physicians & Surgeons (New York City), said that the decades old method of treating glaucoma with eye drops is unsatisfactory because of huge non-compliance issues. Various studies have shown that non-compliance, especially for patients taking two or more medications, can exceed 50%.
"This is the curse of glaucoma," said Cioffi, who added that there is hope on the horizon with several novel drug delivery systems in development. He went on to say that "we already have excellent drugs . . . we just need to deliver them in a better fashion."
Bob Thompson, CEO of Amorphex Therapeutics (Andover, Massachusetts) discussed his company's topical ophthalmic drug delivery device (TODDD), which is a non-invasive topical device that is designed to deliver a glaucoma drug 24/7 for extended periods. TODDD is similar in shape to a contact lens, composed of polymers carefully selected for their comfort and biocompatibility. It rests on the sclera under the eyelid. According to Thompson, it is "easier to handle and insert than a contact lens" and after placement, can provide several weeks of sustained drug release.
Several milestones have been achieved, supported by three Small Business Innovative Research (SBIR) grants from the National Institutes of Health (Bethesda, Maryland). The company has secured several partnerships for specific glaucoma drugs, has demonstrated in vitro release of therapeutic levels of drugs for over 90 days, has shown efficacy in a 90 day timolol animal study, has shown that the device can be worn comfortably for several months nonstop and has had a meeting with the FDA to determine its regulatory path to the U.S. market.
A public company that is addressing the non-compliance challenge with a novel drug delivery approach is pSivida (Watertown, Massachusetts). It has developed a very tiny fully bioerodible device that is injected with a 25 gauge needle through the conjunctiva into the subconjunctival space.
This technology has been embodied in the company's Durasert device for the long term sustained release implant of latanoprost, the most commonly prescribed agent for ocular hypertension and glaucoma in the world.
A Phase I/II clinical trial designed to assess the safety and efficacy of the implant is underway and if successful, the product will enter a multicenter Phase II clinical trial.
The Durasert/latanoprost program is being developed with Pfizer (New York City) pursuant to an R & D agreement between the two companies.
CEO Paul Ashton pointed out that that this is a "third generation" product for his company, following its FDA approvals in 1996 of Vitrasert for cytomegalovirus (CMV) infection and Retisert for uveitis in 2005.
The company's leading development product is Iluvien, an injectable, non-erodible, intravitreal implant for the treatment of diabetic macular edema, a potentially blinding condition that affects approximately one million people in the U.S. alone. This device is designed to release the drug fluocinolone acetonide for up to three years.
It showed solid clinical results in the domestic trial called Fluocinolone Acetonide in Diabetic Macular Edema (FAME) study, which was conducted in conjunction with its partner partner Alimera Sciences (Atlanta). However, as reported in November 2011, Alimera received a letter from FDA that stated that it was unable to approve Iluvien because the NDA did not provide sufficient data to support its safety and efficacy and that the risks of adverse reactions were significant and were not offset by the benefits. The companies are continuing to work towards European approval.
pSivida is now actively developing a fourth generation drug delivery technology called Tethadur, which it describes as a "platform drug delivery system" that relies on nanostructuring to achieve optimal drug delivery.
There appear to be several advantages of Tethadur, including its ability to provide long-term delivery of anti-bodies and other proteins, a high efficiency and capacity of drug loading, a controlled nanostructuring that can vary nanosized pores to accommodate different molecule sizes and is fully bioerodible over range of time periods.
Myriad glaucoma medications have already been incorporated in TODDD and one device has the capability of dispensing multiple drugs simultaneously.
In addition to noting the need to better drug delivery, in his keynote address Dr. Cioffi also indicated that because of the significant fluctuations in intraocular pressure (IOP) that occur throughout the day and night, "the next big frontier for glaucoma management is real-time IOP measurement." An article in the June 2011 issue of the American Academy of Ophthalmology (San Francisco) publication Eyenet noted that IOP measurement over time is "a missing piece" in glaucoma management.
AcuMEMS (Menlo Park, California) is developing an implantable wireless MEMS sensor for wireless remote direct IOP. CEO Doug Lee said that his company plans to introduce two products, one for the anterior chamber and another for the posterior chamber which can be concomitant with cataract surgery. The sensors couple to a handheld reader, facilitating continuous IOP monitoring by the ophthalmologist.
Its major target market will be for glaucoma patients undergoing cataract surgery. Lee estimated this at about 20% of the cataract procedure market and cataract surgery is gaining popularity as a possible first-line therapy for glaucoma. According to Reay Brown, MD, a glaucoma specialist at Atlanta Ophthalmology Associates (Atlanta), "if you look at it from a risk benefit standpoint, cataract surgery is the best glaucoma operation."
The company is currently gathering chronic animal data and hopes to start its human trials as soon as possible.
Implandata Ophthalmic Products (Hanover, Germany) is also developing a micro-sensor device that will continuously monitor IOP. Its approach is similar to AcuMEMS, using a permanent sensor that is implanted and connected remotely to an external handheld device. It will offer two versions of its device, one for intraocular placement in conjunction with cataract surgery and a second device, with extraocular placement for other patients.
The company hopes to gain the CE mark for its intraocular device this year and in 2013 hopes to achieve CE mark and FDA 510(k) approval for its extraocular products.
Larry Haimovitch was president of Haimovitch Medical Technology Consultants (Mill Valley, California), a healthcare consulting firm. His firm specialized in the analysis of the medical device industry, with particular emphasis on the current trends and the future outlook for emerging medical technology.
First published February 14, 2012
Last reviewed on June 09, 2021