Avedro yesterday said the FDA wants more data on its corneal cross-linking technology for treating 2 sight-threatening conditions, meaning the Boston-based medical device company is left with a longer U.S. approval timeline.
Avedro Inc.
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Avedro wins date with joint FDA panel
Avedro said today that it won a date with the FDA next week for its corneal cross-linking technology for treating a pair of eye conditions.
A joint meeting of the watchdog agency’s Dermatologic & Ophthalmic Drugs Advisory Committee and its Ophthalmic Devices Panel is slated for Feb. 24, Boston-based Avedro said.
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Avedro picks up Swiss eye firm
Avedro said today that it augmented its corneal cross-linking capabilities with the acquisition of a Swiss ophthalmology firm, Iroc Innocross AG, for an unspecified amount.
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Avedro application needs more work, FDA says
Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.
Avedro wins FDA priority review
Avedro said the FDA granted priority review to the new drug application for its riboflavin ophthalmic solution used with its KXL system.
The priority review for the Waltham, Mass.-based medical device company draws Avedro closer to treating keratoconus and corneal ectasia. Keratoconus is a potentially blinding disease, for which limited therapeutic treatment is available in the US. Corneal ectasia is a rare outcome of refractive surgery but is a progressive condition that is difficult to manage, according to a press release.
Avedro launches 2 U.S. trials of cross-linking in eye surgery
Ophthalmic medical devices maker Avedro touted the launch of 2 new studies examining its light-based cross-linking, evaluating the therapy in treatment of patients post-Lasik surgery and patients with keratoconus, a degenerative eye disorder.
Avedro wins CE Mark for its KXL II system
Waltham,Mass.-based Avedro said it won CE Mark clearance in the European Union for its KXL II cross-linking system.
The technology uses a photorefractive intrastromal cross-linking procedure for non-surgical correction of myopia as well to improve cataract surgery outcomes, according to a company statement.
Avedro lands $43M in Series D financing round
Medical device company Avedro finished up a $43 million Series D financing round this week with the help of a pair of new investors, venture capital shops Third Point and Abingworth.
To tie the knot, Avedro is bringing on 2 new board members from its latest backers, Abingworth’s David Maye and Jason Hong of Third Point.
Avedro’s products are used primarily in support of Lasik laser eye surgery. The company is currently wrapping up Phase III clinical trials. Currently, none of the company’s products are for sale in the U.S.