Eyeworld

EW GLAUCOMA 30 May 2018 3 clinical observations, it typical- ly takes 6–9 months to prepare a submission." It can then take 6–10 months for the FDA to review the application, then some time for the company to launch the product. EW Editors' note: Dr. Bacharach has finan- cial interests with Allergan, Glaukos, and Ocular Therapeutix (Bedford, Massachusetts). Dr. Mansberger has financial interests with Allergan and Ocular Therapeutix. Dr. Novack has no financial interests related to his comments. Contact information Bacharach: jbacharach@northbayeye.com Mansberger: SMansberger@deverseye.org Novack: gary_novack@pharmalogic.com Examining continued from page 28 Also being considered for sustained release are punctal plugs loaded with medication. Source: Malik Kahook, MD Placing sustained-release devices such as a bimatoprost ocular insert under the upper lid may help with patient medication compliance issues. Source: John Sheppard, MD Dr. Mansberger pointed out that investigators still don't know the lowest amount of drug to get the highest effect with sustained delivery. "I think there are some dose-response curves that need to be done to answer the question about which molecules are going to be best," he said. The prostaglandins are interesting because they have the most IOP lowering, they work well, and there are few side effects, he noted. "They are attractive because there are not that many systemic side effects when you compare them to something like timolol, which has more systemic side effects," Dr. Mansberger said, adding that the carbonic anhydrase inhibitors also have minimal side effects. Howev- er, the alpha agonists are likely not of interest here because of the side effect profile. Dr. Bacharach views the poten- tial molecules that could be utilized here as wide open. "Most of the agents that have been looked at with these delivery devices have been the prostaglandin class because they have shown the highest effica- cy," he said. "But it's very possible that you might be able to combine classes that are currently already marketed like beta blockers, alpha agonists, or CAIs." Stumbling blocks How you get the drug into the eye is part of the sustained-release equation that must be evaluated. One possibility being considered is viral vectors, which Dr. Mansberger thinks has some potential. "I think viral vectors would be interesting if it could change the meshwork so that it starts to work better or change the outflow pathway in some way that it works better," he said. Still, he has concerns about the approach. "I don't think a viral vec- tor given every 3 months would be a good way of delivering medicine because I would expect these viruses to have some sort of inflammatory response that may create untoward side effects." There remain other challeng- es as well with sustained-release implants for glaucoma. Dr. Novack pointed out that one stumbling block with internal systems has been the concept of payload. Part of the sustained-release approach is potency and determining how many milligrams of the molecule that you need. Overall, it will likely take some time before any sustained-release systems become available, Dr. Novack thinks. "Based on public data, the most advanced program at present is the bimatoprost implant, currently in Phase 3," Dr. Novack said. "Upon completion of Phase ASCRS.org/center-for-learning

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