Xiidra first FDA-approved drug for signs and symptoms of dry eye disease

Issue: August 25, 2016

The FDA approved Xiidra for the treatment of signs and symptoms of dry eye disease in adult patients on July 11.

Manufactured by Shire, Xiidra (lifitegrast ophthalmic solution 5%) is the first prescription eye drop medication in a new class of drugs, a lymphocyte function-associated antigen 1 antagonist, to be approved by the FDA for dry eye disease, according to an FDA press release. The drug’s safety and efficacy were assessed in more than 2,500 patients in four separate, randomized controlled studies. The results of the studies found that patients treated with Xiidra demonstrated improvement in their signs and symptoms of dry eye compared with patients treated with placebo.

Robert Dempsey

Robert Dempsey, vice president and head of ophthalmics at Shire, answered several questions about the future direction of Xiidra and its FDA approval in an interview with Ocular Surgery News.

OSN: When is Xiidra scheduled to be placed on the market?

Dempsey: As you know, we gained approval on July 11. We are planning to go to market in the third quarter of this year and have the product available at that time.

OSN: How do you plan to compete with and position Xiidra against Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), as well as the other dry eye treatments on the market?

Dempsey: I would prefer not to comment on other companies’ products and stay focused on Xiidra. It is the first and only prescription eye drop approved for both the signs and symptoms of dry eye disease, and we are focused on bringing a new treatment option for the estimated 16 million patients in the U.S. who are diagnosed with dry eye disease and for whom treatment could be appropriate. We also know that dry eye disease is a very common complaint to eye care professionals, both ophthalmologists and optometrists, so that is where we would like to focus our energies and activities.

OSN: That seems like an advantage, just from the labeling standpoint, that Xiidra is for the signs and symptoms of dry eye disease.

Dempsey: I concur. Our entire team would agree that in that clinical development program of more than 2,500 patients we met the extremely high bar of achieving replication for the signs and symptoms of this common disease. I think it is very good for patients, eye care professionals and Shire as we look at positioning Xiidra to address the unmet patient need. We spent the last 2 years talking to patients and eye care professionals to understand their needs and the opportunity that exists. We are putting together a comprehensive plan to engage both the eye care professionals and the patients.

OSN: Can you give an update on where you stand as far as the national sales structure around Xiidra?

Dempsey: Over the last couple of months, we have been building up our force. We have hired and announced that Kathy Kobe will be head of sales. We have been very active in our recruitment process. We have hired, trained and recently deployed our sales organization to start calling on physicians to introduce Shire and Xiidra to them. Now that the product is approved, we are training them extensively on the product and getting them ready for the official launch of the product this quarter.

OSN: Any plans to expand the leadership team?

Dempsey: Yes, we have been very busy in expanding the leadership team. Obviously with the approval of Xiidra and knowing that was coming, we have been increasing the commercial infrastructure. We have the team in place with medical affairs, a team in place in research and development, and a team in place with the commercial and marketing side. In addition, we have been building out our portfolio.

Vic Noble, our head of marketing, will continue to build out her team to put us in position to maximize this opportunity. Further, now that we are moving forward with filings in Canada and the EU, we are building out our international leadership team.

We recently hired a commercial strategy lead, Beth Marsh, for SHP640, our development program for a novel agent being investigated to treat infectious conjunctivitis (adenoviral and bacterial). That program was acquired through an acquisition last year of Foresight Biotherapeutics. The program is entering phase 3 and will need commercial leadership. Beth is a 20-plus-year veteran of ophthalmics, and we are excited to have her on board.

OSN: What are your plans for filing Xiidra internationally?

Dempsey: Right now, we are looking to file in Canada in the fourth quarter of 2016. Our plan is to file in the first quarter of 2017 in Europe. With regards to Japan, we are still in the process of having discussions with the regulatory agencies to assess the best path forward with this application.

Now that Xiidra is approved in the U.S., it clearly opens up significant opportunities through the rest of the world perspective. We will be looking at these opportunities on a case-by-case basis. With the high bar to obtain an indication for the signs and symptoms of dry eye disease, we believe Xiidra has significant opportunities in the rest of the world.

OSN: Is there anything else you would like to say about the approval or future of Xiidra?

Dempsey: The eye care community and industry have been waiting well over 13 years for a new prescription treatment for dry eye disease to come to the market. When you look at the totality of data, it really is a tribute to our research and development team for the tremendous work that they did in putting together a comprehensive package for the FDA submission and to get this across the finish line. First time it has been done. And tremendous credit should also be given to the drug developers at Shire who, as we like to say, have “cracked the code.” We refer to them as the code breakers. Where a lot of companies have failed, Shire took on this challenge and was successful. It is a tribute to the entire team that we took this over the finish line.

Reference:

FDA approves new medication for dry eye disease. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510720.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. July 12, 2016. Accessed July 13, 2016.

For more information:

Robert Dempsey, can be reached at Shire, 300 Shire Way, Lexington, MA 02421; email: rodempsey@shire.com.

Disclosure : Dempsey is the vice president and head of ophthalmics at Shire.