Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the Ocular Therapeutix's Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. It is now my pleasure to turn the call over to Brad Smith, Chief Financial Officer of Ocular Therapeutix. Please go ahead, sir.

Thanks Chelsea. Good morning everyone thank you for joining us on our second quarter 2016 earnings and corporate update conference call. Earlier this morning, we issued a press release providing an update on the Company's product development programs and details of the Company's financial results for the second quarter ended June 30, 2016, which can be accessed on the Investor portion of our website at investors.ocutx.com. Leading the call today will be Dr. Amar Sawhney, our President, CEO and Chairman, who will provide a summary of our recent clinical and corporate developments, as well as provide an overview of the various key milestones expected through the remainder of the 2016 and beyond. Following Amar's remarks, I will provide an overview of the financial highlights for the second quarter before opening the call for questions. Amar and I are also joined on the call today by Eric Ankerud, our Executive Vice President of Regulatory, Quality and Compliance; Scott Corning, our Vice President of Sales and Marketing, and Dr. Jon Talamo, our Chief Medical Officer. As a reminder, during today's call, we will be making certain forward-looking statements. Various remarks that we make during this call about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor provisions act under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factor section of our most recent quarterly report on Form 10-Q on file with the SEC, which was filed earlier this morning. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some future point, we specifically disclaim any obligation to do so, even if our views change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to today. I will now turn the call over to Dr. Amar Sawhney.

Thank you, Brad. Good morning everyone and thank you for joining us on our call today. I would like to start off by providing a bit more clarity around the recent news with respect to our new drug application or NDA for DEXTENZA for the treatment of ocular pain following ophthalmic surgery. As a reminder the FDA accepted our NDA for review in December, 2015 and we were subsequently issued a target action date under The Prescription Drug User Fee Act of July 24, 2016. The data included in the NDA are from a phase 2 clinical trial and two phase 3 clinical trials conducted with DEXTENZA for the treatment of postsurgical ocular pain and inflammation. On July 25, we announced that we have received a complete response letter or CRL from the FDA. A CRL is issued by the agency when they have completed review of an NDA but cannot approve the application in its current form. Importantly, the CRL did not identify any deficiencies with regards to efficacy or safety concern in the clinical data provided from the NDA for ocular pain indication or any need for additional clinical trials for the approval of the NDA. The items raised in the FDA’s CRL pertained to deficiencies in manufacturing, process and controls which were originally identified by the FDA during pre-NDA approval inspection of the ocular therapeutics manufacturing facility earlier this year. After the FDA’s facility inspection we were issued a Form 483 sighting ten observations. We disclosed the issuance of the Form 483 in our last 10-K filing and our subsequent 10-Q filings. Shortly after receiving the Form 483 we submitted a response back to the FDA including corrective actions in an effort to address these observations. We then received the CRL which did not provide any specific…

Thanks Amar, first with regard to our cash and investment position, as of June 30, 2016, we had $83.9 million in cash, cash equivalents and marketable securities. Our cash used in operating activities was $9.8 million in the second quarter of 2016 compared to $8.5 million for the same quarter in 2015. We expect cash used in operations to be $45 to $47 million for full-year 2016 and expect capital expenditures to be in a range of $4.5 to $5.5 million. This is of course subject to a number of assumptions about our clinical development programs, the commercialization of DEXTENZA and other aspects of our business. This spending will be driven by our phase 3 OTX-TP program for the treatment of glaucoma and ocular hypertension. As Amar indicated, we’ll be starting - expect to start the first of two phase 3 trials in the third quarter of this year. The Phase 3 DEXTENZA programs for the treatment of post-surgical pain and inflammation and allergic conjunctivitis, as well as our clinical development efforts on our dry eye program and preclinical development efforts on our hydrogel depot delivering anti-VEGF drugs for the treatment of wet AMD. It will also be driven by our investment in the anticipated initial commercialization of DEXTENZA with the level of spending subject to the approval of our NDA for ocular pain following ophthalmic surgery. The expected capital investment of 4.5 million to 5.5 million in 2016, net of a tenant improvement allowance, is primarily for build-out costs and modifications to a new building we will be occupying in 2017 that was previously occupied by another life sciences company. While there are existing R&D labs and clean rooms and existing infrastructure supporting our manufacturing and R&D requirements, we do need to make modifications to the space, build several…

Thank you. [Operator Instructions] And our first question comes from the line of Adnan Butt with RBC Capital Markets. Your line is now open.

Hi, good morning. Thanks for the question. First on DEXTENZA, could you shed some light on what negotiations are around for the NDA, is it about the timing of the filing, is it the actual label language and then the label that the company is seeking, is that for post-operative pain in the eye or is that for cataract specifically?

This is Eric Ankerud. The label indication is for treatment of post-operative pain occurring after ophthalmic surgery. The negotiation that we are currently having with FDA is in regard to the complete response letter and closing out the one observation. We have been in dialog with FDA and based on feedback, are preparing to submit a meeting request to discuss that topic with the agency and expect during that conversation to come to an agreement on our response to the one outstanding observation pertaining to the incoming inert gas and also in regard to timing for the agency’s review to close out that issue.

So, thanks. Just the follow-up here, what are the timing of review scenarios once your response for the inert gas testing is submitted?

We are going to propose based upon feedback with our consultants, we’re going to propose to FDA that this be considered a minor resubmission and in classifying the resubmission as minor, the review time is 2 months or less.

Okay. And just a question on the other, question on OTX-TP, as you’re aware different drugs are in development with different delayed release profiles. OTX-TP is, you’re gearing for a three month release. Now, is there expertise in house to have a longer duration OTX-TP should you choose to do it or what’s your thinking around the optimal period still? Thanks.

Adnan, this is Amar. I think short answer of do we have the expertise to design longer release systems, answer is yes, we do. There is basically going to be an extension of what we’re considering. Are we engaged in developing OTX-TP, which is administered, inserted into the canaliculus for a longer period than three months, answer is no, we’re not engaged in that work right now. It has to do not only with whether the duration of release, but also the amount of drug that you want and given the drug loading can only be of a certain amount, given the canaliculus’s size, it is not possible to, right now, think about a six month release profile with enough drug being released. So that’s the primary reason. There may be other approaches that we would be considering. We haven’t talked publicly about them. We are in the process of evaluating some of them, should we make meaningful advances along those lines, where less drug would be required because you’re putting it in a more closer to the target location, then we might be able to do that for longer duration. So that is still in the research process, but for clinical development, we are focusing on the three month profile.

Thank you. Thanks.

Thank you. [Operator Instructions] And our next question comes from the line of Ling Wang with BTIG. Your line is now open.

Thank you for taking my question. Can you provide more color on the mechanism of the pass-through reimbursement, is there a timeline within which the CMS is supposed to get response to you after you submit that application?

Yes. Typically, when you complete the application by the first business date in a given quarter, the earliest date for pass-through to be effective is the following quarter. So for example, if we were to put an application in by the first business date in September, the earliest date for pass-through to be effective would be January 1st. And we are encouraged by a proposed ruling by CMS to change the cycle, such that products applying for pass-through status regardless of the time of the year of submission of their application, they would have three years of transitional pass-through payment status. So regardless of the quarter that we apply for pass-through, we hope or expect or anticipate to have a full three years of pass-through payment status.

I see. And then a follow-up on the [indiscernible], the observation on the manufacturing, you mentioned that you proposed, you wanted to propose to the FDA for the resubmission to be considered as minor resubmission, I was wondering what are the other classifications, like that are out there?

Well, there are -- an alternative classification would be a major resubmission. We believe that our plan for a minor resubmission is due to the fact there is only one outstanding observation to address a relative straightforward observation. A major observation has different timing, according to the significance of the response. But we believe strongly that our submission, our resubmission is classified as minor.

I see, but can you give us some estimate as to how long it might take you to prepare all the results for this opening issue?

We are requesting a meeting with the agency in the September timeframe and if that meeting is granted in that timeframe, we expect to be able to resubmit to the NDA shortly thereafter.

Okay. Thank you.

Thank you. If there no further questions, I will now turn the call over to Amar Sawhney for closing remarks.