Form 8-K - Current report
23 Août 2024 - 2:05PM
Edgar (US Regulatory)
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0001682639
0001682639
2024-08-23
2024-08-23
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UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13
or 15(d)
of the Securities Exchange
Act of 1934
Date of Report (Date
of earliest event reported): August 23, 2024
EYENOVIA, INC.
(Exact Name of Registrant
as Specified in its Charter)
Delaware |
|
001-38365 |
|
47-1178401 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
295 Madison Avenue, Suite 2400, New York, NY
10017
(Address of Principal Executive Offices, and
Zip Code)
(833) 393-6684
Registrant’s Telephone Number, Including
Area Code
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section
12(b) of the Act:
(Title of each class) |
|
(Trading
Symbol) |
|
(Name of each exchange
on which registered) |
Common stock, par value $0.0001 per share |
|
EYEN |
|
The Nasdaq Stock Market
(Nasdaq Capital Market) |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities
Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. | Regulation FD Disclosure. |
On August 23, 2024, Eyenovia,
Inc. (the “Company”) began using an updated corporate presentation with various investors and analysts. A copy of the presentation
is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained
in this Item 7.01, including Exhibit 99.1, is being “furnished” and shall not be deemed “filed” for purposes of
Section 18 of the Exchange Act, or otherwise subject to the liability of that Section or Sections 11 and 12(a)(2) of the Securities Act.
The information contained in this Item 7.01, including Exhibit 99.1, shall not be incorporated by reference into any registration statement
or other document pursuant to the Securities Act or into any filing or other document pursuant to the Exchange Act, except as otherwise
expressly stated in any such filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
EYENOVIA, INC. |
|
|
Date: August 23, 2024 |
/s/ John Gandolfo |
|
John Gandolfo |
|
Chief Financial Officer |
Exhibit 99.1
| August 2024
Our Vision is to Improve Yours
With topical ophthalmic therapies that are easier to use and
easier to live with
EYEN-COM-V2-0021 |
| Forward-looking Statements
Except for historical information, all the statements, expectations and assumptions contained in this presentation are forward-looking
statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations,
strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated
market opportunities for our products, product candidates and platform technology. These statements are based on current expectations,
estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees
of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results
may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to
numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.
In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our and our licensees’
clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing
and our licensees’ ability to submit applications for, obtaining and maintaining regulatory approvals for Mydcombi, clobetasol propionate
and our product candidates; the potential advantages of Mydcombi, clobetasol propionate and our product candidates and platform
technology and potential revenues from licensing transactions; the rate and degree of market acceptance and clinical utility of Mydcombi,
clobetasol propionate and our product candidates; our estimates regarding the potential market opportunity for Mydcombi, clobetasol
propionate and our product candidates; reliance on third parties to develop and commercialize Mydcombi , clobetasol propionate and
certain of our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing,
commercialization and marketing capabilities and strategies for Mydcombi, clobetasol propionate and our product candidates; intellectual
property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of
these changes on our ability to obtain regulatory approval for our products; and our competitive position.
Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable
securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements.
2 |
| 3
Eyenovia: Our Vision is to Improve Yours
Designed for ease of use, enhanced tolerability,
and compliance through digital technology
Optejet®
: Topical Eye Medication
Platform Technology
• Mydcombi for pupil dilation
• Clobetasol for post-surgical inflammation
and pain
FDA-Approved Products
• Cyclosporine/Optejet (EYEN-510) for dry eye
SGN Nanopharma
• Fonadelpar/Optejet (EYEN-520) for dry eye
Senju Pharmaceuticals
Multiple Late-Stage Candidates in the Optejet
• Clobetasol/Optejet (EYEN-530) for acute
dry eye Formosa Pharmaceuticals
• MicroPine (atropine/Optejet) for pediatric
progressive myopia. Arctic Vision in China
and Korea |
| 4
Recent and Near-Term Anticipated Corporate Highlights
3Q 2024
MydCombi
Launch
4Q 2024
Optejet Gen-2
Clinical Plan to FDA
30-day review prior to starting
bridging study in early 2025
Clobetasol Launch to 500 Offices
Advanced topical steroid with desirable
efficacy, safety and dosing profile
Expected to provide immediate revenue;
projected 3rd year market share of 4 - 6%
$1.3 billion US addressable market
MicroPine Phase 3 36-Month Data
Positive result could lead to an NDA filing late 2025
$3.0 billion US + China addressable market
1Q 2025
Dry Eye Collaborations
EYEN-510 (SGN Nanopharma)
EYEN-520 (Senju Pharmaceutical)
EYEN-530 (Formosa Pharmaceuticals)
FDA Meetings: MicroPine
and Dry Eye Products
Commercial Production
Gen-2 Device |
| Recognized Unmet Medical Need
Current options are not appropriate for all
patients and do not eliminate progression risk
$3.0B market in the U.S. and China Major Clinical Milestone expected 4Q 2024
In-House Manufacturing
CMO manufactures drug products
Device and Sterile Fill and Finish by Eyenovia
Strong IP, Non-Substitutable
Unique FDA form with design and
method patents through 2041
Optejet Technology
Easy to use and self-administer
with digital capability to track
adherence and compliance
MicroPine Is Our Premier Near-Term Opportunity in the
Multi-Billion Dollar Pediatric Progressive Myopia Market
(Atropine Ophthalmic Spray)
5 |
| 6
• Begins in early childhood, with genetic
link or environmental factors1
• Elongation of the eye with morbidity
and vision problems2
• Currently no FDA-approved drug
therapies to slow myopia progression
1 Jones LA, Sinnott LT, Mutti DO, Mitchell GL, Moeschberger ML, Zadnik K. Parental history of myopia, sports and outdoor activities, and future myopia. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3524-32.
2 Eye and Contact Lens. 2004; 30
3 Theophanous C. Myopia Prevalence and Risk Factors in Children. Clinical Ophthalmology. December 2018. U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplement, 2019.
Progressive Myopia is a Global Epidemic That Can Lead
to Vision Loss and Blindness if Not Controlled |
| 7
Approximately 5 Million Children are at
High Risk for Vision Loss Without Effective Intervention
-1.4 D
Mean Diopters
at 9-Years-Old
Donovan L. et al., Myopia progression rates in urban children wearing single-vision spectacles. Optom Vis Sci. 2012 Jan;89(1):27-32.
0
0.25
0.5
0.75
1
1.25
1.5
1.75
2
2.25
2.5
2.75
3
3.25
3.5
3.75
4
4.25
4.5
4.75
5
5.25
5.5
5.75
6
6.25
6.5
6.75
7
7.25
7.5
7.75
8
8.25
8.5
8.75
9
9.25
9.5
9.75
10
Predicted Myopic Progression Rates of Untreated 9-Year-Old Children Over 3 Years
-4.45 D
Mean Diopters
at 12-Years-Old
25% of Children could be
expected to be -4.5 D or higher
Significant, vision - threatening Myopia
48% of Children
Considerable Myopia
Still Needing Treatment
27% of
Children
Little to no
myopia
-1.05 D annual change in
diopters for untreated
9-Year-Old children
-3.15 D change average
over three years for
9-Year-Old children
-D Change |
| 8
Lenses are Today the Only FDA-Approved Treatment
1. Optometry and Vision Science94(6):638-646, June 2017
2. Int J Health Sci (Qassim). 2013 Nov;7(3):291-9. doi: 10.12816/0006057
Approved Devices
Over 75% of optometrists, however, feel that using contact lenses in
patients under 10 years of age is not appropriate. Microbial keratitis
being a serious concern for contact lens wearers.
1
A 2012 study showed that two thirds of children did not comply with
wearing their vision correcting spectacles due to various reasons
(Dislike, Lost/Broken, Feel Unnecessary, Teasing)2
Efficacy
“Evaluating children who were prescribed
MiSight® 1 day at the study’s initiation, 23% of
eyes after year six displayed a total refractive
change of less than -0.25D (spherical
equivalent)…”
“Essilor® Stellest® lenses slow down myopia
progression by 67% on average, compared to
single vision lenses…”
Approximate cost to patient $1800 per year for visits and lenses
[$700 lens cost to physician]
Approximate cost to patient $1800 to $2600 per year depending on
severity [$200 lens cost to physician] |
| 9
Atropine eyedrops have been observed to
slow myopia progression in children1
1. Chia A, Chua WH, Cheung YB, et al. Atropine for the treatment of childhood Myopia: Safety and efficacy of
0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology 2012;119:347-354
ATOM-1 Results
400 Subjects
LAMP-1 Results
438 Subjects
There are currently no FDA-approved pharmaceutical options |
| Eye Doctors are using Compounded Atropine Off-label
to Treat Myopia Patients Multifocal Soft Contact Lenses
WHICH TREATMENT INTERVENTIONS DO YOU CURRENTLY
PRESCRIBE TO MANAGE PROGRESSIVE MYOPIA IN
CHILDREN AND ADOLESCENTS?
More Time
Outdoors
Topical Low-Dose
Atropine
Visual Hygiene
Changes
Single Vision
Eyeglasses
Blue-light Blocker
Eyeglasses
Progressive
Eyeglasses
Orthokeratology
Combo- therapy
(e.g., atropine + OrthoK)
Executive Bifocal
Eyeglasses
Other
Published April 2023 Published Jan 2024
N=293
29.7%
23.1% 22.5%
10.1%
8.9%
5.7%
Soft Contact
Lenses
Ortho-K Atropine Combination
Treatments
Spectacles Lifestyle |
| 11
Target Product Profile
• 60% reduction in myopia progression with
minimal rebound after one year
• One spray per each eye daily; easy enough for
children to use without supervision
• Comfortable to instill with minimal impact on the
ocular surface
• Very low systemic exposure, an important
consideration for a multi-year therapy in small
children
• Optecare compliance system provides dosing
reminders and product use history for doctors to
improve treatment success
• Estimated 90% margins based on NSP of
$200/month with COGS of $20/month
The Premier Drug+Device Product Candidate for Progressive Myopia
MICROPINE (atropine ophthalmic spray) |
| 12
CHAPERONE
The Single Phase 3 Trial Required for FDA Approval
• Three arms dosed with 8 microliter ophthalmic spray:
placebo, 0.01%, and 0.1% atropine
• Myopic children in the U.S. between the ages of 3 and 13 at risk for progression
• MicroPine self-administered with the Optejet as one spray in each eye at night
• Three years to efficacy endpoint – myopia progression of less than 0.5 diopters
• Well tolerated; adverse events are infrequent and mild with no SAEs related to drug
treatment. Therapy compliance appears higher than what has been seen historically
with eye drop studies. |
| ● Only MicroPine comes with built-in
Optecare technology to track and
communicate patient compliance data
● In CHAPERONE, the daily treatment
compliance of the first 28 subjects was well
above what was predicted
● Treatment adherence and compliance is
typically a primary determinant of therapy
success
● Payers are strongly motivated to include
therapies on formulary that improve
outcomes1
13
Treatment Compliance via the Optecare System is
What Makes MicroPine Special
1 Data on file with Eyenovia. 2 Naito 2018: Naito T, Yoshikawa K, Namiguchi K, Mizoue S, Shiraishi A, et al. (2018) Comparison of success rates in eye drop instillation between sitting position and supine position. PLOS ONE 13(9):
e0204363. Patel 1995: Patel SC, Spaeth GL. Compliance in patients prescribed eyedrops for glaucoma. Ophthalmic Surg. 1995 May-Jun;26(3):233-6. Winfield, 1990: Winfield AJ, Jessiman D, Williams A, Esakowitz L. A study of the causes
of non-compliance by patients prescribed eyedrops. Br J Ophthalmol. 1990 Aug;74(8):477-80. 3. Matsui, 1997: Matsui DM. Drug compliance in pediatrics. Clinical and research issues. Pediatr Clin North Am. 1997 Feb;44(1):1-14. |
| 14
Potential Peak Sales of Over One Billion Dollars
2027 2028 2029 2030 2031 2032 2033 2034 2035 2036
Number of Potential
Users 5,000,000 5,050,000 5,100,500 5,151,505 5,203,020 5,255,050 5,307,601 5,360,677 5,414,284 5,468,426
Approx. Market Share 0.5% 1% 2% 4% 6% 7% 8% 9% 10% 10%
Cartridge Units 150,000 375,000 937,500 1,640,625 2,460,938 3,076,172 3,537,598 4,068,237 4.678,473 5,380,244
Product Price
(Net of Rebates) $200.00 $200.00 $200.00 $200.00 $200.00 $200.00 $200.00 $200.00 $200.00 $200.00
Gross Sales $30,000,000 $75,000,000 $187,500,000 $328,125,000 $492,187,500 $615,234,375 $707,519,531 $813,647,461 $935,694,580 $1,076,048,767
Assumptions
- Potential users based on number of children at high risk of progressive myopia in the U.S.
- $400 net monthly price less up to 50% rebates (typical for new products in ophthalmology)
- Eight cartridges per year per patient (“cartridge stretching”)
- Base could be sold to physicians at cost as a possible practice builder |
| 15
MicroPine Planned Development Timeline
4Q
2024 2025 2026 2027
File NDA
If positive and statistically significant,
meet with FDA and continue with one-year
additional safety study
Output from
Analysis of
~240
Patients
Potential
Approval |
| 16
• Designed to address issues with ease-of-use and dosing precision
• Delivers efficacy while improving
tolerability and reducing side effects1
• Digital Optecare capabilities2
Optejet® with microdose array print technology
• Patented digital device platform technology
• Unique, class-leading drug products
• High-value product pipeline addressing areas of
significant medical and market need
• Multi-faceted business model with revenue from
direct sales and licensing agreements
Introducing the Optejet®
The Only FDA-Approved Ophthalmic Digital Drug Delivery Platform
1. Wirta DL, Walters TR, Flynn WJ, Rathi S, Ianchulev T. Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials. Ther Deliv. 2021 Mar;12(3):201-214.
2. Optecare is Eyenovia’s suite of digital compliance and adherence capabilities |
| 17
The Optejet® Consists of a Replaceable
Cartridge (COGS of $20) and Durable Base
Spray nozzle with
109 laser-drilled ports
Shutter
Activation button
Ergonomic design
Proprietary, pre-filled drug cartridge
manufactured by Eyenovia
Optejet uses technology similar to that of Inkjet printers to “print” microdroplets of drug
onto the eye, using ¼ of the dose of conventional eye drops to maintain efficacy and
minimize tolerability issues |
| 18
The Optejet Delivers 80% Less Drug Volume Than Eye Droppers
Sufficient for efficacy while improving benefits from reducing excessive exposure to both drugs and preservatives 1,2
1 Wirta D. et al, Presentation at 2019 ASCRS meeting | 2 Ianchulev T. et al, Therapeutic Delivery 2018 | 3 Hamrah, P. et al. Cytotoxicity Evaluation for BAK-preserved Latanoprost Delivered By Drop vs.
Microdose Array Print Technology. ARVO 2023 poster. New Orleans, LA| 4 The impact of precision spray dosing of netarsudil 0.02% can be seen when compared to a single drop of the same drug.
Improves Local Tolerability and
Decreases Systemic Exposure4
Minimizes Excessive Drug
Exposure to Ocular Tissues3
When tolerability is poor, patients are very likely to
discontinue their medication or put pressure on the
ophthalmologist to change their treatment5
3
4 |
| 19
Optejet Digital Technology is Optecare
The Optejet® is capable of
automatically tracking usage
OPTECARE:
Multiple Benefits for All Stakeholders
PATIENT
• Reminders to take medicine
• Ability to track compliance progress
• Opportunity for brand-specific encouragement
• May be monetized through app subscription
service
PHYSICIAN
• Ability for quicker action with more
accurate data
• Opportunity for billing: CPT Code (98980)
for monthly check of compliance data
PAYER
• Cost savings: Less likely to have patient on
second medication if compliance is the issue
• Better outcomes: Compliance with drug therapy
shown to slow disease progression1
1 Shu YH et al. Topical Medication Adherence and Visual Field Progression in Open-angle Glaucoma. J Glaucoma 2021 |
| 20
Broad Intellectual Property Portfolio
• Key claims covered with multiple patents
– 18 US Patents Issued; 8 pending
– 89 foreign issued; 33 pending
– Many in effect to 2041
• Clinical data and regulatory approval
adds another layer of IP |
| 21
Multiple Collaborations and Licensing Opportunities
In Large Markets
1. Estimates from IQVIA Sales Data | 2. Eyenovia Estimates chronic dry eye is 90% and acute is 10% of total dry eye market of $6.1B (Dry Eye Disease Market (Jan 2024) Transparency Market Research. Available at:
https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=26096)
Target Market Partner or Status United States
Addressable Market
Collaboration Agreements
and Potential Opportunities
Glaucoma
• EYEN-610 (Open Phase 2 IND for latanoprost in
combination with the Optejet) $2.7B1
Acute Dry Eye
• EYEN-530 (Formosa Pharmaceuticals, potentially
superior clinical profile with BID dosing, Phase 3) $0.6B2
Chronic Dry Eye
• EYEN-510 (SGN Nanopharma, faster acting
cyclosporin; Phase 2b)
• EYEN-520 (Senju, peroxisome proliferator-activated receptor delta agonist, Phase 2b)
$5.5B2 |
| 22
Three Product Candidates Addressing Distinct
Market Segments in Dry Eye with the Optejet
EYEN-510
MNP Cyclosporine
EYEN-520
Fonadelpar
EYEN-530
Clobetasol
Foundational Therapy Adjunctive Therapy Flare-Ups
Faster-acting
Immunomodulator inhibiting
the production of cytokines
involved in the regulation of
T-cell activation.1
Promotes wound healing after
and block corneal fibrosis.2,3
Reduce symptoms of meibomian
gland dysfunction and expression
level of inflammatory cytokines4
Inhibits release of pro-inflammatory cytokines &
chemokines stimulating the
release of anti-inflammatory
cytokines
1. Russell G, Graveley R, Seid J, al-Humidan AK, Skjodt H. Mechanisms of action of cyclosporine and effects on connective tissues. Semin Arthritis Rheum. 1992 Jun;21(6 Suppl 3 2. Zhou HY, Zhang WS, Bi MM, Wu J. The molecular mechanisms of action of PPAR-γ
agonists in the treatment of corneal alkali burns (Review). Int J Mol Med 2016;38(4):1003-1011 3. Yoshikuni Nakamura, Takahiro Nakamura, Takeshi Tarui, Jun Inoue, Shigeru Kinoshita,Functional Role of PPARδ in Corneal Epithelial Wound Healing, The American Journal
of Pathology.80(2) 2012. 4. Mu PY, Chu CC, Yu D, Shao Y, Zhao SZ. PPARγ: the dominant regulator among PPARs in dry eye lacrimal gland and diabetic lacrimal gland. Int J Ophthalmol. 2020 Jun 18;13(6):860-869 |
| 23
Clobetasol Propionate
Ophthalmic Suspension 0.05%
FDA-APPROVED
For the treatment of post-operative inflammation and pain
following ocular surgery
This presentation is not an advertisement for clobetasol propionate. |
| Safety Information
IMPORTANT SAFETY INFORMATION: Clobetasol Propionate Ophthalmic Suspension 0.05% is indicated for the treatment of post-operative
inflammation and pain following ocular surgery. CONTRAINDICATIONS: Most active viral diseases of the cornea and conjunctiva, including
epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of
ocular structures. WARNINGS AND PRECAUTIONS: Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in glaucoma
with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If
this product is used for 10 days or longer, IOP should be monitored. Cataracts: Prolonged use of corticosteroids may result in posterior subcapsular
cataract formation. Delayed Healing: The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Corneal and Scleral Melting: In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of
topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient
with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. Bacterial Infections: Prolonged use of
corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids
may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. Viral
Infections: Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of
ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal
Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion
must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when
appropriate. ADVERSE REACTIONS: Ocular adverse reactions occurring in ≥ 1% of subjects in clinical studies who received clobetasol
propionate ophthalmic suspension 0.05% included eye inflammation (2%), corneal edema (2%), anterior chamber inflammation (2%), cystoid
macular edema (2%), intraocular pressure elevation (1%), photophobia (1%) and vitreous detachment (1%). Many of these reactions may
have been the consequence of the surgical procedure. PLEASE GO TO CLOBETASOLBID.COM FOR FULL PRESCRIBING INFORMATION
24 |
| Expected to Provide Near-Term Revenue to Fund Optejet Projects
25
Ophthalmology’s First New Steroid in 15 Years
Physicians now have access to a well-characterized steroid with an advantageous profile
* https://www.formosapharma.com/technology/
Clobetasol Propionate Ophthalmic Suspension 0.05%, BID
Strong efficacy in pain relief
and inflammation reduction
Safety and tolerability
with low incidence of
IOP spikes
Simplicity for patients
with twice-a-day dosing
Patented APNT*
Science
Guaranteed access for all
patients regardless of
insurance status |
| 26
Clobetasol Utilizes APNT* Technology
* https://www.formosapharma.com/technology/
Clobetasol Propionate Ophthalmic Suspension 0.05%, BID
Active ingredient is milled down with salts and sugars
to nanoparticle size
Active Pharmaceutical Nanoparticle Technology:
Increases dissolution • Increases bioavailability
Stable and excellent dispersion properties
Clobetasol Propionate
No Shaking
Required
Other Steroids |
| 27
Rapid and Sustained Ocular Pain Relief and Clearance of Inflammation
Percent of Patients with Complete Resolution of Pain
at Post-Operative Days 4, 8, and 15
81.4%
84.7%
88.5%
47.4% 44.5% 45.8%
0%
20%
40%
60%
80%
100%
POD4 POD8 POD15
Percent of Patients with Anterior Chamber Cell Count = 0
at Post-Operative Days 8 and 15
31.1%
58.2%
12.3%
17.3%
0%
20%
40%
60%
80%
POD8 POD15
Clobetasol
Propionate
Placebo
N=366
N=382 |
| 0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1.5% Dexamethasone 0.05% Clobetasol 0.1% Dexamethasone +
DuraSite
0.1 % Inveltys 0.5% Lotemax 0.05% Durezol
% of Patients Pain Free Day 15
A Larger Separation Between Active and Placebo Groups May Not Be Indicative of Relative Efficacy
28
Ratio of Patients Pain-Free at Day 15 Post-Op
Summary of Published Studies
QD QID
2.2x
1.4x
1.8x 1.4x
1.8x
0.05% Clobetasol2 0.1% Dexamethasone +
DuraSite3
0.1% Inveltys4 0.5% Lotemax5 0.05% Durezol6
BID
1. https://www.sec.gov/Archives/edgar/data/1953530/000119312523206201/d519954d424b3.htm 2. https://clobetasolbid.wpenginepowered.com/wp-content/uploads/2024/03/Clobetasol-Prescribing-Information.pdf 3. Evaluate ISV-305
Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery https://www.clinicaltrials.gov/study/NCT03192150?tab=results 4. Inveltys Package Insert https://www.inveltys.com/pdf/inveltys-prescribing-information.pdf 5. Lotemax package insert https://clinicaltrials.gov/study/NCT01060072? 6. Durezol package insert https://clinicaltrials.gov/study/NCT01060072? Head-to-head comparisons are not anticipated.
1.04x
1.5% Dexamethasone1
ACTIVE PLACEBO |
| 0%
10%
20%
30%
40%
50%
60%
70%
1.5% Dexamethasone 0.05% Clobetasol1 0.1% Dexamethasone +
DuraSite2
0.1 % Inveltys3 0.5% Lotemax4 0.05% Durezol5
% of Patients Pain Free Day 15
29
Ratio of Patients with No Inflammation Day 15 Post Op (ACC Grade = 0)
Summary of Published Studies
QD QID
3.5x
3.0x 1.9x
1.9x
3.4x
0.05% Clobetasol2 0.1% Dexamethasone
+ DuraSite3
0.1% Inveltys4 0.5% Lotemax5 0.05% Durezol6
BID
1. https://www.sec.gov/Archives/edgar/data/1953530/000119312523206201/d519954d424b3.htm 2. https://clobetasolbid.wpenginepowered.com/wp-content/uploads/2024/03/Clobetasol-Prescribing-Information.pdf 3. Evaluate ISV-305
Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery https://www.clinicaltrials.gov/study/NCT03192150?tab=results 4. Inveltys Package Insert https://www.inveltys.com/pdf/inveltys-prescribing-information.pdf 5. Lotemax package insert https://clinicaltrials.gov/study/NCT01060072? 6. Durezol package insert https://clinicaltrials.gov/study/NCT01060072? Head-to-head comparisons are not anticipated.
2.4x
1.5% Dexamethasone1
ACTIVE PLACEBO
A Larger Separation Between Active and Placebo Groups May Not Be Indicative of Relative Efficacy |
| 1. https://clobetasolbid.wpenginepowered.com/wp-content/uploads/2024/03/Clobetasol-Prescribing-Information.pdf 30
Low Rate of Adverse Reactions with Clobetasol
All of Which Occurred in 2% or Fewer Patients1
Many of these reactions may have been consequences of the surgical procedure
Eye Inflammation (2%)
Corneal Edema (2%)
Anterior Chamber Inflammation (2%)
Cystoid Macular Edema (2%)
Intraocular Pressure Elevation (1%)
Photophobia (1%)
Vitreous Detachment (1%) |
| Sales force is identifying 500 offices who are ready to
prescribe and/or stock clobetasol
31
Clobetasol Commercial Strategy
ACTIVATING CUSTOMERS Q3 2024
MINIMIZING BARRIERS TO Rx
Pricing similar to current patient out-of-pocket costs
No insurance necessary
Controlled distribution via e-pharmacy familiar to ophthalmologists
No call backs - No prior authorizations - No hassle to offices |
| 32
MydCombi
Ophthalmic Spray
(1% tropicamide and 2.5% phenylephrine)
FDA-APPROVED
For short-term in-office or pre-surgical pupil dilation
This presentation is not an advertisement for MYDCOMBI. |
| Safety Information
IMPORTANT SAFETY INFORMATION: MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic
spray) 1%/2.5% is indicated to induce mydriasis for routine diagnostic procedures and in conditions where
short term pupil dilation is desired. CONTRAINDICATIONS: Known hypersensitivity to any component of the
formulation. WARNINGS AND PRECAUTIONS: FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION. This
preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of
psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be
considered. Mydriatics may produce a transient elevation of intraocular pressure. Significant elevations in blood
pressure have been reported. Caution in patients with elevated blood pressure. Rebound miosis has been
reported one day after installation. Remove contact lenses before using. DRUG INTERACTIONS: Atropine-like
Drugs: May exaggerate the adrenergic pressor response. Cholinergic Agonists and Ophthalmic Cholinesterase
Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic
cholinesterase inhibitors. Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects
of some inhalation anesthetic agents. ADVERSE REACTIONS: Most common ocular adverse reactions include
transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye
discomfort. Increased intraocular pressure has been reported following the use of mydriatics. Systemic
adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea,
vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of
tropicamide. PLEASE GO TO MYDCOMBI.COM FOR FULL PRESCRIBING INFORMATION
33 |
| 34
Spray nozzle with
109 laser-drilled ports
Mist button
Proprietary, pre-filled and
replaceable drug cartridge
containing tropicamide and
phenylephrine
Fill button
Base Unit with
rechargeable battery
Cartridge Base
Proprietary, pre-filled drug
cartridge manufactured
by Eyenovia
MydCombi
(1% tropicamide and 2.5% phenylephrine) ophthalmic spray
A Milestone for Eyenovia with the First FDA-Approval of Optejet® Technology |
| 35
• Up to eight times less drug used compared
with two eye drops
• In two Phase 3 studies, pupil dilation
achieved by MYDCOMBI was statistically
superior to tropicamide or phenylephrine
administered alone
• Nearly all (94%) subject eyes achieved
clinically significant effect compared to
78% of eyes administered tropicamide or
1.6% of eyes administered phenylephrine1
• Only 1 of 131 subjects reported eye
stinging upon use
Fast, Effective Pupil Dilation Without the Sting or Mess
MydCombi Tropicamide Phenylephrine Placebo
1. Pupil diameter greater or equal to 6mm at 35-minutes post-spray |
| Target MydCombi offices have
been selected based on
interest in Optejet technology
Offices are introduced to
MydCombi and Optejet
technology by Key Account
Manager
Key Account Managers ensure
seamless implementation
from drop bottles to MydCombi
Expanded sales team aiming to introduce MydCombi to 200 additional offices before 2025
36
MydCombi Office Outreach
1 4 6 10 8
42
70
270
0
50
100
150
200
250
300
0
2
4
6
8
10
12
Q1 Q2 Q3 Q4
Key Account Managers Customer Accounts |
| 37
NASDAQ: EYEN
Optejet®
Topical Eye Medication Platform Technology
Major Upcoming Milestone in Pediatric Myopia,
a market worth $3B in the US and CHINA
Two FDA-approved Products that are being
launched by 10-person salesforce
Late-Stage Candidates in Dry Eye and Glaucoma,
both are multi-billion dollar markets
Our Vision is to Improve Yours |
| 38
Financial Snapshot - June 2024
Nasdaq: EYEN
Common Shares Outstanding 55.8M
Equity Grants Outstanding Under Stock Plans 7.0M
Convertible Notes 2.3M
Warrants 10.9M
Fully Diluted Shares 76.0M
Cash $2.3M
Debt (up to $5.0M may be paid through the convertible notes) $14.8M |
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Eyenovia (NASDAQ:EYEN)
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