Avedro has submitted its New Drug Application for its riboflavin ophthalmic solution/KXL System (corneal cross-linking for the treatment of keratoconus and corneal ectasia following refractive surgery), and has a PDUFA date of April 16. In February 2015, the company presented to the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee, where the system was recommended for approval. Post-panel, the FDA questioned the equivalence of the device the company submitted for approval, and the device that was ultimately used in the clinical trial.
Avedro recently closed on $32 million in financing for its next undertaking. The Mosaic System performs a procedure called PiXL (Photorefractive Intrastromal Cross-Linking), which “has the potential to deliver non-surgical correction of myopia, and improve cataract surgery outcomes,” according to the company.
This device helps to change the biomechanics of the eye. For the past year, the firm has evaluated the device at numerous clinical sites around the world and treated “several hundred patients with different paradigms to narrow down what the nomogram parameters should be for low myopes (–1.5 D to –1.75 D) and low hyperopes and those with astigmatism,” Dr. Muller said.
The evaluations really formed the essence of a Good Clinical Practices study, and one-year results are now being evaluated and collected. Avedro was targeting two doses to determine how each dose affected patients when targeting emmetropia. In low myopes, the goal was to assess the quantity of sphere reduction. Early results indicate there is greater sphere reduction with lower energy (i.e., a patient who needed 5 lines of uncorrected visual acuity improvement would need 15 joules; 3 lines would require only 10 joules). Best-corrected visual acuity was improved in all patients. One patient lost 1 line of vision post-procedure. Stability through nine months is maintained; none of the patients have reported dry eye, glare, or halo. At one year, “every patient treated is performing well,” Dr. Muller said.
The procedure has been developed to address minor corrections in pseudophakes as well. Dr. Muller noted the procedure is non-ablative, without tissue removal, and produced a “nice, central flat cornea.”
David Muller, PhD
Dr. Muller recognized the potential of using advanced methods to gently reshape the cornea and in 2007 founded Avedro, Inc., where he serves as the CEO.