USA: FDA-approved drugs and devices
Drug: Cyclosporine ophthalmic emulsion 0.05%
FDA approved: 2002
Manufacturer: TearScience (now part of Johnson & Johnson)
FDA approved: 2011
OUTSIDE THE USA:
Following are examples of dry eye drugs that are marketed outside the US. Some of these drugs went through extensive clinical trials and were rejected by the FDA, so their developers were forced to turn to other markets.
DIQUAS (diquafosol sodium 3%) - Santen. Approved and marketed in Japan. Diquafosol had been turned down by the FDA three times.
MUCOSTA (rebamipide ophthalmic suspension 2%) - Otsuka Pharmaceutical. Approved and marketed in Japan.
CACICOL: This not a dry eye drug but rather a regenerating agent used for corneal repair. I mention it here because of readers with extreme dry eye and non-healing corneas.
in the pipeline
- CyclASol (Novaliq GmbH) - combines cyclosporine A with Eyesol drug-delivery platform, intended to make the drug more bioavailable.
- Klarity (Imprimis Pharmaceuticals): topical ophthalmic solution created by Dr Richard Lindstrom to "protect and heal the ocular surface in moderate-to-severe DED"; also intended "for dry eye and corneal irregularities arising from intraocular surgery or contact lens wear" (RevOphth, Oct 2017)
- LacriPep (TearSolutions Inc) - From an interview with developer Dr Gordon Laurie (RevOphth, Oct 2017): "“Lacripep is a synthetically generated 19-amino-acid fragment of lacritin,” Dr. Laurie explains. “Lacritin is a naturally occurring protein in tears, first identified in 2001 by the Laurie Cell Biology Lab out of an unbiased discovery screen for factors that regulate basal tearing.” He notes that Lacripep-like lacritin fragments occur naturally in tears secreted by healthy eyes—and that they are deficient (as is lacritin) in dry-eye tears. “Lacripep and lacritin have been studied in several dry-eye animal and human cellculture models, and have been found to restore ocular surface health by: promoting tear protein release and tearing, even under conditions of inflammation; transiently stimulating a cellular lysosomal pathway known as autophagy to rid cells of damaged proteins and organelles that accumulate under conditions of stress; and restoring mitochondrial oxidative phosphorylation. In unpublished data, both also appear to stimulate and benefit sensory nerves at the ocular surface that in dry eye are disrupted and diminished,” he says.
- RGN-259 (RegeneRx) for dry eye and neurotrophic keratitis. Announced results for some neurotrophic keratitis patients 4/25/18.
- OCU310 (OcuGen) - combo brimonidine tartrate and loteprednol etabonate, cleared phase 2, expected to enter phase 3 in 2018
- OCU300 (OcuGen) - brimonidine nanoemulsion for ocular GvHD
Good article (albeit slightly outdated) about why dry eye trials so often fail.
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