Sean Ianchulev
Analyst · ROTH Capital. Your line is now open
Thank you, Tram and welcome everyone to Eyenovia’s second quarter 2018 earnings conference call. In the first half of 2018, we continue to progress with the development of our extensive late-stage pipeline, in addition to further validating our novel therapeutic platform for -- with compelling results from our PG21 study and the notice of grant of additional patterns in the U.S. As we prepare investigation on new drug applications to initiate Phase 3 development for our programs, we have decided to accelerate our MicroPine problem to address the significant medical unmet need and potential market opportunity of progressive myopia. We look forward to submitting two INDs this year and anticipate initiating all three Phase 3 programs throughout late 2018 and 2019. And with the over-the-counter registration of MicroTears for dry eye on the horizon, we are beginning to develop commercial and marketing strategies with the hire of Michael Rowe as our VP of Marketing. Michael will play a critical role in advancing our position as an innovator, focusing on the possibilities that microdosing brings to the field of ophthalmology. For the past one hundred years, almost all topical treatments to the eye, from glaucoma to dry eye, have been delivered using the legacy eye dropper technology, and with this technology delivering of medication is highly variable. In a compelling study highlighted in JAMA ophthalmology, researchers used video recording to evaluate patient performance of eye drop installation. The study found that only one third of patients were able to successfully deliver medication through eye base on three key performance criteria; successful installation into the eye, installation of only a single drop in not touching of the bottle to the eye. Other studies have also identified that patient deliver a mean of 2.6 drops to the eye and such the bottle keeps to their eye in approximately 50% of installations. These results run against patient’s perception of their own success, when up [ph] more than 60% of patients believe that they never meet their eye drops and 90% report no problems putting in their eye drops. In reality though, patients truly don’t realize that they aren’t getting the prescribed dose or missing their eye entirely when installing high drops, potentially leading to ineffective treatments or overdosing which may lead to topical and systemic side effects. Recently, we completed the full knowledge [ph] of the PG21 study investigating the medication administration effectiveness and IOP lowering effect of microdose latanoprost 0.005% in 60 eyes of 30 healthy volunteers. In the study, participants received once daily microdose treatment over 2 consecutive days and underwent diurnal IOP intraocular pressure assessment four times a day. The primary outcome we examined was success of microdose delivery, with additional outcomes evaluating diurnal intraocular pressure change each day. In the study, after a brief medication administration training session, investigators successfully administered high-precision piezo-print microdose latanoprost with a single spray 95% of the time. A separate evaluation of patient self-administration showed an 88% success rate following limited training. This is a dramatic leap inefficacy and accuracy of delivery, and almost double what is seen with conventional eyedropper technology. In addition, each single medication administration was within 1 micro liter of the prescribed dose and the tear capacity of the eye, while eye dropper administration typically delivers as much as 300% more with high variability of dosing. Our PG21 study also affects the topical ocular delivery of highly precise microdose, which matched the physiologic tear film capacity of the eye in single digit micro liter volumes reducing exposure of toxic preservatives and medications to the eye by more than 75%. We believe this is extremely important for patients with glaucoma, dry eye and myopia who might need chronic therapy for ears and suffered the side effects of dose therapies. Needless to say, we are extremely happy that Eyenovia may be on the threshold of introducing a new paradigm of high precision, high efficacy topical delivery for front and back of the eye therapies where patients and doctors maybe assured the prescribed dose is delivered to the eye accurately and consistently. We believe this will further reduce wave of improved safety and potentially lead to better care in the field of ophthalmology. Furthermore, as we reported previously the study also demonstrated that, while reducing drug administration volume by 75% by delivering the microdose accurately and directly on the corneal surface, piezo-print micro-formulated latanoprost achieved a very robust reduction in diurnal intro ocular pressure of upto 29% from baseline unmedicated intro ocular pressure. This is consistent with the reported reduction of up to 26% achieved with the same concentration of standard latanoprost eye drops. We find these results very encouraging as you will recall we reported similar confirmatory results from our two earlier Phase II trials in mydriasis, which have already been published. In addition to the PG21 study, we also recently noted – we received two notices of allowance from the United States patent and trade mark office granting us two patents which provide us with fundamental coverage on physiologic microdroplet ejection diameters and velocities, which enabled the gentle delivery of ophthalmic therapeutics to the eyes at velocities that beat the eye blinks reflex. This patents are key to delivering how our micro formulations and expand our IP portfolio to a total of eight in the U.S. Furthermore, we currently have seven pending patents in the U.S. and 54 pending patents worldwide. Turning now to our clinical product programs, starting with MicroPine [ph] for the treatment of progressive myopia, which is becoming an increasingly important part of our pipeline. Progressive myopia is the back of the eye disease characterized by increased axial length and progressive elongation of the eye, causing increased refractive error in nearsightedness. In the U.S. alone, there is a estimated 5 million children with significant myopia, with that number rising sharply to nearly 80% to 90% of young adults in Asia. Without an FDA approved therapy to slow progression, we expect to see an increase in the rates of visual impairment by 7 to 13 fall by 2055. We believe this creates a significant market for a therapy designed to slow progression with an estimated treatable population greater than that of the total addressable population for open angle glaucoma and wet macular degeneration combined. Recently, academic institutions have conducted two major collaborative studies examining the therapeutic activity of topical atropine, which is an anticholinergic agent used for dilation. This studies which were large five year randomly controlled trial demonstrated that atropine can slow myopia progression by upto 60%. Despite these studies though, there remains no FDA approved treatment for myopia progression to our knowledge. We think this is because current formulations of atropine have an unacceptable safety profile with significant side effects as well as a very short shelf life. However, these studies indicate that low dose atropine offers acceptable efficacy with better tolerability and safety profile, laying the groundwork and significantly reducing the risk of using low dose atropine. With that said we are very excited to accelerate our MicroPine program for [Indiscernible] desubmission and will prioritize the Phase III trial to start in the first half of 2019. Using our microdose approach, we can deliver precisely 6 to 7 micro liters of atropine to the eye in order to potentially obtain the desired therapeutic effect and eliminate 75% of formulation load and exposure. MicroPine is also stable formulation with a two year shelf life. Furthermore, as we had previously mentioned, after discussion with the FDA, the agency has indicated that potentially only one Phase III pivotal study will be required for MicroPine which will reduce the cost and timeline we need to invest to reach the potential NDA submission. Finally, as we prepare for the over-the-counter registration of our dry eye product MicroTears in 2019, we have begun developing, marketing and commercial strategies and we’re excited to bring on board Michael Rowe as our VP of Marketing. Michael is a veteran of marketing professional and has more than 20 years of experience commercializing products in the U.S. and globally. He has particular expertise in the ophthalmology space having joined us from Aerie Pharmaceuticals, where he was responsible for the U.S. and international commercialization, planning and execution of Rhopressa. He also spend 12 years at Allergan, where he supported the strategic planning for the company’s worldwide glaucoma franchise. Mike will help lead the charge as we plan to introduce our revolutionary technology to ophthalmologists, optometrists and patients, starting first with MicroTears into the Eyecare practitioner’s office. We feel confident that Michael's commercial ophthalmology experience will be an will be an invaluable asset in planning our strategic direction as we near commercialization. And now I would like to turn the call over to John to discuss our financial results.