Eyenovia, Inc.

May 12, 2022. I would now like to turn the conference over to Eric Ribner with LifeSci Advisors. Please go ahead.

Good afternoon, and welcome to INOVIA's first quarter 2022 earnings conference call and audio webcast. With me today are INOVIA's Chairman, Chief Executive, and Chief Medical Officer, Dr. Sean Ianchulev, Chief Operating Officer, Michael Rowe, and Chief Financial Officer, John Gandolfo. This afternoon, Inovia issued a press release announcing financial results for three months ended March 31st, 2022. We encourage everyone to read today's release as well as Inovia's annual report on Form 10-K for the year ended December 31st, 2021, which was filed with the FCC on March 30th, 2022. The company's press release and annual report are also available on Inovia's website at inovia.com. In addition, this conference call is being webcast to the company's website and will be archived for future reference. Please note, on today's call, we will be discussing investigational product candidates which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Inovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are subject to a number of risks, which are described in more detail in our annual report and Form 10-K and most recently filed 10-Q. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 12, 2022. Inovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law. With that said, I'd like to turn the call over to Dr. Sean Ianchulet.

Thank you. Thank you, Arik. and welcome everyone to our first quarter 2022 financial results conference call. We're excited to report on a quarter during which we continue to make notable progress with our presbyopia clinical program, as well as the preparation for the refiling of our medriasis drug, the Mitcombi, with the FDA. We continue to track towards the third quarter resubmission of the Mitcombi NDA. Mitcombi is our investigational program for pharmacologic medriasis, We have now successfully completed three of the four device validation tests of the OptiJet device that had been requested by the FDA following our reclassification as a drug-device combination product. The last test should be completed by late summer. None of these evaluations involve clinical work, so we remain on track to resubmit our MitCombi NDA in the third quarter of this year, consistent with our prior guidance. We're assuming a six-month review period and are making plans for a targeted commercial launch, if approved, for the first half of next year. As we have stated previously, much of the device validation work just described for Mitcombi may be referenced in regulatory filings for our other programs that also use the OptiJet device, including Microline and Micropin, potentially streamlining the FDA review process for those product candidates after other data requirements are also fulfilled. In parallel, we continue to enroll patients in our Vision 2 Phase 3 study for our microline presbyopia program and anticipate top-line data in the middle of this year. If positive, we plan to begin manufacturing our registration lots to support stability and commercial expiration dating as a requirement for the NDA for microline. Many of you have likely seen the advertisement for Allergan's VUIDI, a pilocarpine-based presbyopia eye drop that was approved by the FDA in October of last year for the temporary improvement of near and intermediate vision. We believe that VUIDI is helping to create this new multibillion-dollar market for pharmacologic presbyopia treatment. where one did not previously exist. We believe our MicroLine product, if and when approved, will be poised to capture a significant share of this market due to the many unique benefits of the OptiJet dispenser, not the least of which is its superior tolerability profile that we demonstrated in Vision 1, and we are looking to replicate also in Vision 2. Michael will expand on that and the other benefits shortly. These are exciting times for Inovia as we believe we have a clear line of sight to two commercially approved products, both leveraging our proprietary OptiJet dispensing technology. At this point, I'll turn the call over to Michael for an update on our operations. Michael.