Thank you, Doug, and good afternoon, everyone; and for those of you listening from Australia, good morning. I appreciate everyone taking the time to join us to review our 2017 fiscal third quarter results and corporate update.
I want to begin today's call by emphasizing that throughout our organization there is a high level of enthusiasm. This is due to the substantial achievements we've made over the past few quarters on the regulatory, clinical and collaborative fronts. I continue to be impressed with our Durasert technology, and our efforts these past few months have created several near-term milestones, especially as we approach the end of our fiscal year in June. As evidenced by our progress, the reprioritization of pSivida's development program, one from higher risk, longer term in its focus to one that is now more moderate risk and nearer term, is expanding the pipeline and yielding positive results. We have increased the number of shots on goal.
Let me review the status for each of our programs and the substantial developments you can look for in the coming months. I will then ask Deb Jorn, our Executive Vice President of Corporate Development, to provide some details on our recent market research and collaboration agreements.
I'll begin with Durasert 3-year for posterior segment uveitis and then move on to the other programs. Our most advanced clinical program is our Durasert 3-year treatment for posterior segment uveitis. Posterior segment uveitis impacts approximately 80,000 to 100,000 patients in the United States and another 80,000 to 100,000 patients in Europe, who have few options to treat this chronic inflammatory disease, the third leading cause of blindness in the developed world.
The FDA required 2 Phase III studies, and if you recall, the first Phase III study met its primary efficacy p-value of less than 0.001 and yielded safety data that's consistent with the known effect of ocular corticosteroid use. While we remain blinded to the study, we remain optimistic because of the first trial design and robustness of the data, that the second Phase III study readout will also be positive.
The last patient follow-up occurred in early April, and Rod Riedel, our Vice President of Regulatory Affairs, has been out in the field visiting each of the sites as we keep to our time line and expect to report the second Phase III study readout by the end of June.
In February we also met with EU regulators and the discussions are progressing well, and our current expectation is that the European Market Authorisation Application, or MAA, will be submitted by the end of next month. Concurrently, we are having advanced discussions with several potential organizations and we plan to announce an outlicense partner for Durasert in the EU sometime no later this summer. In the U.S., we expect to file the NDA during Q4 2017, and our plan here is to go to market ourselves with a limited number of contract sales reps and scale up slowly over time.
However, since this is an orphan disease, I don't expect us needing more than 15 to 20 contract sales representatives to cover the uveitis specialists. The focused, small field force, coupled with a favorable gross margin, should contribute to our bottom line performance and shareholder return in a shorter time period than the typical pharmaceutical launch.
During the last few weeks, we were also notified that abstracts featuring our Durasert technology were accepted at leading medical conferences. These acceptances clearly demonstrate the depth of our science and high level of interest from the ophthalmic community.
The first one is next week at the Association for Research in Vision and Ophthalmology, or ARVO, annual meeting in Baltimore on May 8, 2017. The data will be presented in a podium presentation by Dr. Glenn Jay Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, North Carolina.
The second presentation will be at the American Society of Retina Specialists, or ASRS, annual meeting, being in Boston in late August. The data will be presented by Dr. David Callanan, M.D., a leading ophthalmologist with Texas Retina Associates. Having our data presented at these conferences by 2 leading authorities on uveitis is impressive and important as we prepare to submit and launch Durasert in the EU and U.S. markets. As I mentioned earlier, Deb Jorn will provide information on our market research and collaboration agreements.
Moving beyond the eye is our Durasert implant for severe osteoarthritis of the knee. As we have reported, the Hospital for Special Surgery, or HSS, in New York, and pSivida announced the opening of an IND in support of an investigator-sponsored clinical study of Durasert to treat severe OA of the knee. The Durasert implant is designed to provide long-term pain relief for severe knee OA. This can potentially benefit a percentage of the patients that need to delay a total knee replacement, especially for those who need to improve their health or lose weight prior to knee surgery.
I'm pleased to announce the sixth and final patient in the Phase I knee OA study was implanted in early April. We expect HSS to report the initial 24-week data by the fourth quarter of calendar 2017, and we are currently in discussions with HSS about the next steps for this exciting program.
Now turning to our other technology product development opportunities. Our next-generation, shorter-duration product is something we envision for the treatment of posterior segment uveitis and for use in collaborations with other drug manufacturers with their small molecules.
As I've stated before, having the ability to deliver a 3 to 6-month shorter-duration product has significant value to patients as they just -- excuse me, to physicians, as they treat their patients. In addition to our 3-year product, this project remains on track. Of note, our shorter duration for uveitis as well as our collaboration outreach efforts weren't even being contemplated a year ago, so the company's culture and technology road map has changed, and our goal is to better leverage the investments made over the previous years.
Turning to our TKI program for wet AMD, the evaluation of additional TKIs are underway and we've identified multiple suitable TKI candidates for further formulation work. We've determined that pending the evaluation of TKI candidates, we intend to advance this program only through a collaboration partner.
Turning to Tethadur, given that we do have limited resources and we are emphasizing our development efforts on our proven Durasert technology, we have deemphasized our focus on Tethadur. We are continuing to examine areas where we can leverage our Tethadur program, but any efforts would be through a collaboration agreement.
With that, I'll turn the call over to Deb Jorn for a review of our current market research and an update on our collaboration efforts. Deb?