$EYEN: Medium-Term PDUFA Play

Eyenovia is a late-clinical stage ophthalmic research company; in which develops new medications for use in or on the eyes. The company is working to improve microdosing formulations of existing ophthalmic drugs through a highly precise, targeted delivery system. he company has two drug candidates in advanced development. MicroLine, under investigation as a treatment for presbyopia - a gradual loss of the eye’s ability to focus on nearby objects - has successfully completed the Phase 3 VISION-1 study, and a second Phase 3 trial, called VISION-2, is scheduled for initiation by year’s end. Another drug candidate, MicroPine, is a treatment for nearsightedness in children. This drug has completed enrollment for the Phase 3 CHAPERONE study.

But the drug of interest here is MydCombi, a proprietary, first-in-class combination of pupil dilation drugs. MydCombi is intended as an anesthetic-free, microdosing agent for use in ophthalmic eye exams. This is a high-potential niche, as there are tens of millions of office-based eye exams performed annually in the US alone. In addition, an estimated 4 million cataract surgeries annually are likely to use the drug candidate as well.

Announced positive topline data from its Phase 3 VISION-1 study evaluating MicroLine for the treatment of presbyopia

Company on track to initiate second Phase 3 presbyopia trial, VISION-2, by year-end 2021

The FDA is expected to make its decision on Eyenovia’s NDA for MydCombi shortly, with a PDUFA date set for October 28. A positive decision will clear the path for commercialization, targeting the extensive potential patient base.

Note that the current share price is where it is due to dilution in the past year, with total shares outstanding growing by 4.5%.

In the short term, the customer’s assets are at $29.5M, with $14.56M in liabilities. Long term, while this play isn’t suggesting for a long-term play, has $1.09M in assets, and $7.03M in long-term liabilities. Currently, EYEN’s short term assets exceed their short & long term liabilities. This short term liquidity is a sign that Eyenovia could probably pay off its debt with ease.

This play is primarily on the FDA approval set much later. The expirations are monthlies, and they are currently quite cheap.

Highlights from the Second Quarter of 2021:

  • 71% of patients reported a meaningful improvement in near vision according to an exit survey conducted by study investigators.
  • Subjects treated with MicroLine 2% were 7.7 times more likely to achieve the primary endpoint of 3-line or greater improvement in near vision as compared to placebo (Odds Ratio=7.7; statistically significant difference p<0.05).
  • MicroLine had a favorable safety profile, with no serious adverse events and fewer than 3% of study participants reporting headache (including brow ache), instillation discomfort or moderate hyperemia.

EYEN currently trades at $5.51 at the time of this post. The premiums for the options are quite “cheap”. This play is deemed risky as it plays on the contingency that the PDUFA approves the nasal spray.

Granted, there aren’t many analyst ratings on EYEN, but its listed as a strong by across only 3 ratings, with an average price of $15.50, with a high of $19.00, low of $12.00. This stock is hitting pretty “rock-bottom” prices, so it adds de-risk in general, therefore, I find that the upside to this is far bigger than the downside. hOw lOw cAn iT gO?

An alternative play may be $OYST, its been mentioned already. For this one, its set for Oct 17th for the PDUFA approval. It trades at a much higher price, however.

This is my first time doing any type of DD, let me know what you guys think, also let me know if I left out key details you found in your own research, as well as anything I may have missed that would deem this play to be bad out of the gate. I’m trying to give back to a community that hasn’t stop giving since I joined - this is a step!

I’ll make edits here and there with any new information/corrections.



Thanks for the post, will keep an eye out for this.


I see what you did there…

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Thank you.

And … saying PDUFA out loud makes me laugh :laughing:

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Thanks for your DD, greats info.

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Interesting, will keep an eye on it

Thanks for DD. Will keep an eye :+1:

Thanks PH1 for the DD on EYEN I have profited great so far I am sure it will only grow as we get closer to OCT.28

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Great dd will keep an eye on this

Made a very small entry on near Friday close. Seems promising.

Thanks for the DD.

watching this closely. thinking of waiting for a small pullback then putting a small position in shares and riding the positive momentum before the 28th.


Bad news this morning:

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Yep, I sold on the high 6 rise, but I think this may be good entry points after some time consolidating under here for a long-call into 2022. Congrats to anyone who bought in at the time of the post (5.30’s) to 6.00-6.80!

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