Hoping Eyenovia Has The Aye Votes From The FDA In The Near Future (NASDAQ:EYEN)

With this article, I wish to give an update on Eyenovia (NASDAQ:EYEN) since my last article was published back in March 2022. Much has happened in the interim period, and the FDA is set to give an update on their receipt and acceptance of Eyenovia’s new NDA with the data supporting the validity and use of the delivery devise, Optejet. Based on the historical timeline with the FDA, this decision should happen in December. With the FDA accepting the filing, then we are looking at no more than six months for their final decision on what would be Eyenovia’s first FDA-approved product.

On November 21, 2021, I shared my first article on Eyenovia with my readers. My second article was shared on SA on March 3, 2022. At the time, I saw great merit in the potential for this small biotech working the critical needs area for diseases associated with our eyes and related vision. At the time, the stock was trading a little off the recent high of $7.00 a share. The stock was reacting to several key milestones that had happened. One is that the FDA’s decision for their filed NDA was expected in the near term. There was also the factor that they had two other drugs for much larger indications in the advanced stages of development. But at the time of my article, it was critical for them to get this first drug approved as this would validate their new technology, which should revolutionize how most medications are doses for eye issues faced in our growing and aging worldwide population. I had established a position in the stock for an average price of $5.00.

Then the unexpected event occurred where the FDA opted to force Eyenovia into doing more validating of the delivery device. This simply was the case that due to a recent lawsuit and its findings, and not related to Eyenovia, the FDA had to review Eyenovia’s drug under a new protocol of drugs and their delivery devices. The FDA said there were no questions about the drug. Therefore, no clinical trials for that part of Eyenovia’s NDA were required. Investors should also keep in mind that the Optejet delivery device was used by huge numbers of patients during the clinical trials and thus produced stellar and relevant data. Since the drug had been dosed into the eye, this means the drug was effective in dilating the patient’s eyes. But now Eyenovia had to provide more data for the device.

For newcomers to Eyenovia and wanting to learn the recent history, I would suggest you read my previous two articles and which have links shown in this article.

Why Eyenovia?

The foundation of Eyenovia’s uniqueness is its revolutionary Optejet delivery device.

The standard option for dosing a medical drop intended for an ophthalmology indication has been the dated method of using an eye dropper for the dosing episode. For those who have seen their eye doctor recently, you probably remember the doctor’s assistant would ask you to lean your head back and then use an eye dropper to dispense a drug to your eye for dilation. There is a reason the nurse has given you Kleenex tissue before she does this routine of dilating your eye. And if you are like me, the Kleenex comes into use. The Eyenovia solution resolves this wastage of the eye dropper-delivered drug with their Optejet delivery device.

Instead of me sharing my laymen’s knowledge of this unique delivery device, let me share with you a link to an article from the American Academy of Ophthalmology. The article is titled: “Wouldn’t it be great if eyedrops didn’t spill out of your eyes?

What Eyenovia brings to the drug market goes beyond just the three drugs that Eyenovia has undertaken at this stage of clinical development. The current validation is being done by the FDA, assuming the decision supports the Optejet delivery devise. This will open the market to all the drug companies with eye disease drugs under development or currently approved by the FDA.

Not only does the Optejet system deliver the dosage with more direct application to the eye, but the device also has the technology that monitors the dosage and has the ability to give up-to-date data for monitoring the patient’s diligence for proper dosing of the drug. This information is shared with the attending physician and the patient. With the high cost of some of these drugs, proper usage by the patient is important. The eye dropper doesn’t have the consistent ability to dose the drug properly. For example, there is wastage associated with using an eyedropper that is due to the overflow of the drug and the patient blinking at the wrong time. Also, there could be adverse events due to the additives found in the eye dropper drugs. There are ducts located in our eyes sockets, and drugs dosed with eye droppers and the additives they have; can enter the patient’s body through these ducts. This adds to the potential for adverse events happening to the patients.

Major Events During the Period Since My Last Article:

Eyenovia has fully completed the build-out of its manufacturing facility located in Redwood City, CA. They now have the capability to manufacture and package for delivery of their products. They have employed a person who has extensive experience in manufacturing a drug product. In fact, this employee, Bren Kern, was promoted on December 8^th to being their Chief Operating Office and Corporate Vice President. As stated earlier in the article, Eyenovia has resubmitted its NDA for its dilation drug—MydCombi. This drug is licensed to Arctic Vision for the China and Korean markets. Arctic Vision is funding the necessary clinical trials for this market.

Eyenovia plans to self-market this drug in the US. There are approximately 100 million comprehensive eye exams done in the US each year. This drug is a prescription drug not subject to insurance coverage; this is a drug paid for by the attending physician. If Eyenovia can convenience the doctor that MydCombi and its delivery is a time and money saver, the US market is about $250,000,000.00 a year.

Eyenovia has just completed a Phase III trial with their presbyopia drug, MicroLine, for the treatment of far-sightedness. They are in conversation with the FDA, or will be soon, discussing the next step in getting FDA approval for their drug, which currently has a marketing value of $7.5 billion just here in the US.

The third trial Eyenovia has in advanced clinical trials is MicroPine. This drug is for treating pediatric myopia, and the market in the US and Canada is valued at $5.0 billion a year. This drug is in Phase III development, with clinical enrollments with patients having been completed. Overall, Eyenovia has partnership deals with Arctic Vision (China and Korea), Senju (India and Southeast Asia), and Bausch (BLCO) for the US and Canada markets.

The market size numbers can be found for each drug on the Eyenovia corporate website.

Let me stress; potential investors should review in-depth any available information–SEC filings and corporate websites before they invest in a stock. For biotech investing, this is a more critical issue for investors.

On November 29^th, 2022, Eyenovia received a $25.0 million dollar credit facility. At the time, this gave them a cash position of $25.5 million. Eyenovia expects this cash should get them into 2024.

Caveats:

As mentioned earlier in this article, prior to the FDA decision to require additional testing for the device, the stock was trading at the $7.00 level. As you can see, the stock is currently trading around the $2.00 level. Eyenovia is a small biotech with no current revenue stream, and any delay in reaching or obtaining such revenues, the massive drop in the NASDAQ of about 30%, impacted the stocks like Eyenovia even more. An investor should make note that even though Eyenovia currently has this pending NDA with the FDA and two more drugs in advanced clinical trials, the future for them lies in the FDA giving approval for their 0ptejet delivery system. There is no surety that the FDA might not outright reject the Optejet delivery system, even though the clinical test previously done clearly delivers the drug to the eye with positive results. I would be cautious about buying this stock until the FDA makes its decision. My cardinal rule: Until the FDA gives its final approval for an NDA, anything can happen, and one can be bad news for shareholders.

Conclusions:

I would normally suggest to my readers to avoid sub-$5.00 stocks. However, in the case of Eyenovia, it came to my attention when it was trading above $5.00. Eyenovia complied with the guidelines that the FDA had in place when they got approval from the FDA to conduct their clinical trial for MydCombi. They had no idea that the rules would be changed just as they were awaiting final approval from the FDA. Instead, they had to restart a clinical trial for MydCombi. The benefit of this delay, if the FDA approves MydCombi, the other drugs in their pipeline will not face the same delay.

Within days the FDA should give approval or deny the current refiled NDA for MydCombi. If one is interested in investing in Eyenovia, one might wait until the MydCombi issues are resolved with the FDA. As always, I suggest any investor do more due diligence than my article offers. I think it important to review their recent Phase III data for the MicroLine drug. Investors were valuing the company at $7.00 before the FDA disrupted the party. If the news is good, we could see a nice rebound in the share price. The yearlong assault on the NASDAQ stocks has seen a 30% overall drop in this index. There is no doubt that Eyenovia’s stock is part of this 30% drop. However, I see a glimmer of hope soon.

Good luck with your future investing!