Tropicamide

Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced its financial and operating results for the first quarter ended March 31, 2024. First Quarter 2024 and Recent Business Developments Announced updated plans to accelerate development of its late-stage product candidate for pediatric progressive myopia, MicroPine. These plans include a protocol amendment to allow for a Data Monitoring Committee to review the Phase 3 CHAPERONE study data early in the fourth quarter. External sources have valued the pediatric progressive myopia market at over $3.0 billion annually in the U.S. and China.Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery. Eyenovia is planning a launch of this product in the third quarter of 2024. Clobetasol has a desirable clinical profile as compared to other topical ocular steroids with twice-a-day dosing, a high level of efficacy and with adverse events occurring in fewer than 2% of patients.Reported training and shipping product to 50 new Mydcombi-using offices by its initial five Key Account Managers since sales promotion started in April 2024. Additionally, formulary agreements with Vision Source and the University of California have been executed.Reduced the Company’s anticipated cash-based expenses by approximately $0.8 million per quarter from first quarter 2024 actual levels. Michael Rowe, Chief Executive Officer, commented, “During the first quarter of 2024, we took tangible steps to increase the inherent value of our company, which currently includes our novel Optejet technology, two FDA-approved products, and a third in late Phase 3 development. With highly differentiated and desirable products such as Mydcombi for mydriasis and clobetasol for post-surgical pain and inflammation, we look forward to meaningful sales growth over the next 18 months that we anticipate will lead us towards profitability. And our crown jewel, MicroPine for progressive myopia, if approved, would add significant value to the company by addressing a key unmet medical need of the approximately five million at-risk children in the U.S. alone.” “We believe the progress that we continue to make toward optimizing our platform technology has laid a strong foundation towards transforming Eyenovia into a leader in the development and commercialization of topical ophthalmic products and medications. We are committed to demonstrating the value of our existing and near-term products as well as future product candidates in ophthalmic markets with high unmet needs.” “At the same time, we completed the build-out of our manufacturing capabilities, with FDA approval of our Redwood City location in addition to our Reno facility and Coastline International as our contract manufacturer. With all three facilities online, we are currently producing commercial supply of Mydcombi while at the same time supporting both current and future development partnerships as well as our transition from the Gen-1 to Gen-2 Optejet dispenser. To that end, we recently requested a meeting with the FDA to discuss our validation of the Gen-2 dispenser, which we anticipate will occur this summer,” Mr. Rowe concluded. First Quarter 2024 Financial Review For the first quarter of 2024, net loss was approximately $10.9 million, or $0.23 per share, as compared to a net loss of $5.7 million, or $0.15 per share, for the first quarter of 2023. The first quarter 2024 net loss includes $2.5 million of expense, or $0.05 loss per share, associated with the reacquisition of the license rights from Bausch for MicroPine and the write off of related clinical trial inventory. Research and development expenses totaled approximately $4.4 million for the first quarter of 2024, compared to $2.5 million for the first quarter of 2023, an increase of approximately 75.7%. For the first quarter of 2024, general and administrative expenses were approximately $3.8 million, compared to $2.9 million for the first quarter of 2023, an increase of approximately 30.6%. Total operating expenses for the first quarter of 2024 were approximately $10.3 million, including the previously referenced $2.5 million of expenses associated with the Bausch transaction, compared to approximately $5.5 million for the first quarter of 2023. This represents an increase of approximately 88.1%. The first quarter 2024 operating expense figure includes approximately $1.5 million of non-cash expenses. As of March 31, 2024, the Company’s unrestricted cash and cash equivalents were approximately $8.0 million, not including $2.2 million in additional capital the Company raised in April 2024. Conference Call and Webcast The conference call is scheduled to begin at 4:30 pm ET today, May 15th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13746269. To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of the conference call will also be available here and on the investor relations page of the Company's corporate website at www.eyenovia.com. After the live webcast, the event will be archived on Eyenovia’s website for one year. PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05% About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic nanosuspension 0.05% to reduce pain and inflammation following ocular surgery, which was approved by the FDA on March 4, 2024. Eyenovia is also advancing late-stage development of medications in the Optejet device for presbyopia (Apersure) and myopia progression (MicroPine, partnered with Arctic Vision in China and South Korea). For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release 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. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of any disruptions on our supply chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; the risk of defects in, or returns of, our products; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; our competitive position; and other risks described from time to time in the “Risk Factors” section of our filings with the U.S. Securities and Exchange Commission, including those described in our Annual Report on Form 10-K as well as our Quarterly Reports on Form 10-Q, and supplemented from time to time by our Current Reports on Form 8-K. 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. Eyenovia Contact:Eyenovia, Inc.John GandolfoChief Financial Officerjgandolfo@eyenovia.com Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363 Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com EYENOVIA, INC. Condensed Balance Sheet March 31, December 31, 2024 2023 (unaudited) Assets Current Assets Cash and cash equivalents $7,976,106 $14,849,057 Inventories 3,513,860 109,798 Deferred clinical supply costs 846,301 4,256,793 License fee and expense reimbursements receivable 88,045 123,833 Security deposits, current 1,506 1,506 Prepaid expenses and other current assets 2,025,267 1,365,731 Total Current Assets 14,451,085 20,706,718 Property and equipment, net 3,155,710 3,374,384 Security deposits, non-current 197,168 197,168 Intangible assets 6,122,945 2,122,945 Operating lease right-of-use asset 1,538,814 1,666,718 Equipment deposits 711,441 711,441 Total Assets $26,177,163 $28,779,374 Liabilities and Stockholders' Equity Current Liabilities: Accounts payable $2,145,272 $1,753,172 Accrued compensation 828,286 1,658,613 Accrued expenses and other current liabilities 4,751,755 287,928 Operating lease liabilities - current portion 579,585 501,250 Notes payable - current portion, net of debt discount of $621,712 and $503,914 as of March 31, 2024 and December 31, 2023, respectively 8,155,025 5,329,419 Total Current Liabilities 16,459,923 9,530,382 Operating lease liabilities - non-current portion 1,140,231 1,292,667 Notes payable - non-current portion, net of debt discount of $200,711 and $448,367 as of March 31, 2024 and December 31, 2023, respectively 2,103,456 4,355,800 Convertible notes payable - net of debt discount of $344,219 and $398,569 as of March 31, 2024 and December 31, 2023, respectively 4,655,781 4,601,431 Total Liabilities 24,359,391 19,780,280 Stockholders' Equity: Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023 Common stock, $0.0001 par value, 90,000,000 shares authorized; 47,386,349 and 45,553,026 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively 4,738 4,555 Additional paid-in capital 158,226,694 154,486,098 Accumulated deficit (156,413,660) (145,491,559) Total Stockholders' Equity 1,817,772 8,999,094 Total Liabilities and Stockholders' Equity $26,177,163 $28,779,374 EYENOVIA, INC. Condensed Statements of Operations(unaudited) For the Three Months Ended March 31, 2024 2023Operating Income Revenue $4,993 $- Cost of revenue (4,993) - Gross Profit - - Operating Expenses: Research and development 4,431,601 2,521,950 General and administrative 3,835,223 2,936,886 Reacquisition of license rights 2,000,000 - Total Operating Expenses 10,266,824 5,458,836 Loss From Operations (10,266,824) (5,458,836) Other Income (Expense): Other (expense) income, net (97,558) 70,993 Interest expense (678,658) (454,003)Interest income 120,939 102,480 Total Other Expense (655,277) (280,530) Net Loss $(10,922,101) $(5,739,366) Net Loss Per Share - Basic and Diluted $(0.23) $(0.15) Shares Outstanding - Basic and Diluted 46,606,790 37,410,587

Company announces results from a Phase IV study of Mydcombi designed to characterize the efficacy and duration of the lowest deliverable dose (one 8µL spray per eye) Also announces upcoming ARVO presentation on the unique technology behind clobetasol that allows for future ophthalmic suspensions to be dispensed with the Optejet® NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today provided an update on its two FDA-approved products. Phase IV study of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% Eyenovia announced today results from a Phase IV study of Mydcombi® designed to characterize the lowest deliverable dose for mydriasis (pupil dilation). Mydcombi is the only FDA-approved fixed dose combination of tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%, and the first FDA-approved product in the Optejet®. Current mydriatic eye drops used during eye exams have several limitations, including potential cross-contamination, difficulty instilling in patients with limited mobility, and in some patients, tolerability and safety issues. Phenylephrine, in higher amounts, has been known to cause serious potential systemic cardiovascular side effects in older patients, particularly those with high blood pressure. This Phase IV study was designed to determine the efficacy and duration of effect of the lowest deliverable dose of Mydcombi for pupil dilation. Twenty-nine subjects were treated with a half dose of Mydcombi (8µL per eye) and evaluated at the end of 2023 at the State University of New York School of Optometry by Dr. Denise Pensyl, OD. Study highlights: At 30 minutes post dose, clinically relevant pupil dilation was achieved in approximately 67% of patients; By 60 minutes, that percentage increased to 86%; The majority of patients returned to a pupil size of less than 5mm between 3.5 and 6 hours post-instillation, with 93% reaching that point by 6 hours; Administering a lower 8 microliter volume was well tolerated with minimal adverse events reported. “The results of this study highlight the favorable efficacy and tolerability of Mydcombi dispensed through the Optejet,” stated Michael Rowe, Eyenovia’s Chief Executive Officer. “Notably, dilation was already dissipating by 3.5 hours post-instillation, which is similar to published studies of dilating eye drops followed by the use of a mydriasis reversal agent. These results suggest that for patients in which the lowest deliverable dose of tropicamide and phenylephrine may be desired, the precision and flexibility of the Optejet technology may be an option for eye care professionals and their patients.” Eyenovia plans to present the full data set at an upcoming medical meeting this year. Results of this study can be found at: ARVO Presentation Eyenovia also announced today that the company will deliver a presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting, which is being held May 5-9, 2024, in Seattle, WA. The presentation will detail results from a study demonstrating that Formosa Pharmaceuticals’ Active Pharmaceutical ingredient Nanoparticle Technology (APNT™) can improve solubility and bioavailability of topical ophthalmic medications. Eyenovia licensed clobetasol propionate ophthalmic suspension 0.05%, which leverages APNT technology, from Formosa in August 2023, and clobetasol was subsequently approved by the U.S. Food and Drug Administration (FDA) for the treatment of post-operative inflammation and pain in March 2024. Eyenovia is planning to launch clobetasol later this summer, as a complement to Mydcombi, the company’s commercially available mydriasis agent. “The data presented at this year’s ARVO Annual Meeting further demonstrates that APNT represents an exciting new drug manufacturing technology with the potential to deliver suspensions through our Optejet dispenser,” continued Mr. Rowe. “We look forward to incorporating this technology in future products, as well as launching clobetasol which uses APNT. Clobetasol will be the first new ophthalmic steroid in many years, participating in a market estimated to be worth in excess of $1.3 billion annually.” Presentation details: Title: Evaluation of APNT™ Nanoparticle Formulation in Ophthalmic Medications Presentation Number: 3991 - B0035 Date: May 7, 2024 Time: 3:30 PM to 5:15 PM PT (6:30 PM to 8:15 PM ET) Additional information on the ARVO meeting can be found here: About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is a commercial stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the commercialization of Mydcombi for mydriasis, as well as the ongoing late-stage development of medications in the Optejet device for presbyopia and myopia progression. For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. Forward-Looking Statements Except for historical information, all the statements, expectations and assumptions contained in this press release 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 product candidates and platform technology, and the timing for availability and sales growth of our approved products. 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 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 clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and 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 product candidates; 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. 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 IMPORTANT SAFETY INFORMATION: MYDCOMBI (tropicamide 1% and phenylephrine HCl 2.5%) ophthalmic spray 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: Not for Injection: Topical ophthalmic use. Significant Elevations in Blood Pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment. Central Nervous System Disturbances: Caution in pediatric patients where rare incidences of central nervous system disturbances have been reported. Intraocular Pressure: May produce a transient elevation. Rebound Miosis: Reported 1 day after administration. 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. To report SUSPECTED ADVERSE REACTIONS, contact Eyenovia, Inc. At 1-833-393-6684 or FDA at 1-800-FDA-1088 Eyenovia Contact: Eyenovia, Inc. John Gandolfo Chief Financial Officer jgandolfo@eyenovia.com Eyenovia Investor Contact: Eric Ribner LifeSci Advisors, LLC eric@lifesciadvisors.com (646) 751-4363 Eyenovia Media Contact: Eyenovia, Inc. Norbert Lowe Vice President, Commercial Operations nlowe@eyenovia.com