Interview: Avedro executives discuss FDA approval of cross-linking system

Healio/OSN spoke with Avedro’s Chief Medical Officer Rajesh K. Rajpal, MD, and Vice President of Marketing David Iannetta about the importance of the US approval.

Healio/OSN: The ophthalmology community in the U.S. has been waiting for this approval for quite a while. Can you put this into perspective for ophthalmologists and discuss the importance of this particular approval?

Rajesh K. Rajpal, MD: I think ophthalmologists across the U.S. and eye care providers in general have been anxiously awaiting the ability to perform cross-linking, or to be able to offer cross-linking is probably a better way to say it, to progressive keratoconus patients, and it is a dramatic event for all of us in the eye care industry, but also especially for patients. We hear from so many patients who are anxiously awaiting this, so I think it has been a huge event and it is a major opportunity for patients to get care for something that they have not been able to in the past.

Rajesh K. Rajpal

Healio/OSN: What kind of impact will it have on optometry?

Rajpal: I think optometry will continue to be as closely involved in caring for keratoconus patients as it has always been. I think optometrists and ophthalmologists who work together will determine how they continue to share in the care of these keratoconus patients. Certainly, patients after cross-linking continue to need optometric care. Many of them continue to wear contact lenses and are fit by optometrists in customized lenses frequently. So, I think the care will continue for both, and I think both ophthalmologists and optometrists are extremely happy to have what is available because ultimately it allows our patients to achieve better care.

Healio/OSN: For the uninitiated, can you explain how cross-linking works on the cornea?

Rajpal: Collagen cross-linking works by applying riboflavin solution on the eye and then activating it with an ultraviolet light. The combination of the riboflavin becoming activated by the UV light with the interaction of oxygen creates new corneal collagen cross-links, a shortening and thickening of the collagen fibrils, and leads to stiffening of the cornea.

Healio/OSN: Tell us about your own experience with cross-linking and work with Avedro.

Rajpal: I have been involved on the medical advisory board for Avedro, and I have been a principal investigator in the clinical trials for several years with Avedro. Over the last month I officially became chief medical officer, and I am spending a portion of my time in that role and the rest of the time in my clinical practice.

I have been involved in several clinical trials related to cross-linking, and the results have certainly been similar to what we have seen in the data available from the clinical trials that were sent to the FDA. The level of flattening, as well as the reduction in progression, has been significant.

Healio/OSN: Were there any remarkable aspects of the clinical trials and approval process that you would like to comment on?

David Iannetta: I think one part of the process that was unique is the fact that it is a combination drug and device. It is the Photrexa formulations combined with the KXL device, and that has its own complexities of working through the process. We had to go through both the drug process as well as the device process, which is unique.

Healio/OSN: Are there other applications Avedro is researching for cross-linking?

Rajpal: Internationally, custom cross-linking with our Mosaic device is being looked at as a method of correcting relatively low refractive errors and reducing perhaps dependence on glasses or just improving vision. That procedure has been termed PiXL — photorefractive intrastromal cross-linking. Those clinical trials are ongoing outside the U.S., and we do anticipate ultimately having interest in trying to start those clinical trials in the U.S.

Healio/OSN: What else would you like the ophthalmic community to know?

Rajpal: The importance of the approval within the world of eye care providers and perhaps more importantly, again, from the perspective of patients. Progressive keratoconus is a condition that is relatively rare. It has been classified as an orphan disease, and the unmet need for the patients has been dramatic. The ability to now be able to have an approved combination drug and device in the U.S. is huge when so many of our colleagues outside the U.S. have been able to have this for so many years, and ultimately, again, it is a major advance for our patients. We certainly appreciate that the FDA ultimately was able to recognize this and approve the combination.

Disclosure: Rajpal is chief medical officer of Avedro, and Iannetta is vice president of marketing at Avedro.