Treating Progressive Keratoconus
Addressing Important Unmet Clinical Needs in Corneal Health
Glaukos’ acquisition of Avedro combines two complementary, hybrid pharmaceutical and device ophthalmic organizations and establishes the cornerstone for Glaukos’ new corneal health franchise.
Avedro’s platform uses its proprietary, bio-activated, single-use Photrexa®Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) drug formulations to strengthen corneal tissue and slow or halt progression of keratoconus, a degenerative corneal ectatic disease that affects approximately 1 in 2,000 people in the United States. Typically diagnosed in a patient’s teenage years, keratoconus is characterized by progressive thinning and weakening of the cornea, resulting in vision loss. Approximately 90% of cases are bilateral and as many as 20% of patients ultimately require a corneal transplant. Conventional treatments address symptoms but the Avedro platform is the first and only FDA-approved therapy that has been shown to slow or halt disease progression.
Avedro has also developed a pipeline of novel single application bio-activated topical ophthalmic pharmaceuticals that are designed to treat common refractive conditions, including presbyopia, low myopia and post-cataract refractive error.
Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.
Important Safety Information
Corneal collagen cross-linking should not be performed on pregnant women.
Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects. The most common ocular adverse reaction was corneal opacity (haze). Other ocular side effects include punctate keratitis, corneal striae, dry eye, corneal epithelium defect, eye pain, light sensitivity, reduced visual acuity, and blurred vision.
These are not all of the side effects of the corneal collagen cross-linking treatment. For more information, go to www.livingwithkeratoconus.com/ to obtain the FDA-approved product labeling. You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
In addition, Glaukos is developing a patented, non-invasive, transdermal drug delivery platform designed for use in the treatment of dry eye disease, glaucoma and corneal disorders such as allergy, blepharitis, conjunctivitis and related conditions. Early human studies of this novel delivery system have demonstrated efficacy while limiting the side effects often associated with drugs delivered as topical eye drops. This novel drug delivery platform adds to several organic corneal health R&D initiatives we already have in place.