Presbyopia

Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative pain and inflammation following ocular surgery Reacquired development and commercialization rights to MicroPine for progressive pediatric myopia in the U.S. and Canada Continued to advance commercial operations with launch of Mydcombi™, FDA approval of manufacturing facility, onboarding of sales organization and signing of copromotion agreement Company to host conference call and webcast today, March 18th, at 4:30 pm ET NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today announced its financial and operating results for the fourth quarter and full-year ended December 31, 2023. Fourth Quarter 2023 and Recent Business Developments Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% (“clobetasol”) for the treatment of post-operative pain and inflammation following ocular surgery, which the company in-licensed from Formosa Pharmaceuticals for the U.S. With the transfer of the clobetasol NDA for this product to Eyenovia, the company is planning to launch in the second half of 2024 with its existing 10-person sales force.Reacquired the development and commercialization rights to MicroPine in the U.S. and Canada. MicroPine is currently being evaluated in the Phase 3 “CHAPERONE” clinical trial for pediatric progressive myopia. External sources have estimated the value of this market at over $1 billion dollars in the U.S., and of a similar size in China.Announced FDA approval for the Redwood City manufacturing facility. Along with approval of Coastline International in Mexico and Eyenovia’s facility in Reno, Nevada, the company is now the manufacturer of the finished Mydcombi product for commercial distribution.Hired, trained and deployed half of its planned 10-person field sales force, with the remainder set to join in the coming weeks.Signed an agreement with Vision Source, a large buying group consisting of optometrists throughout North America, to offer Mydcombi as an approved product to its member offices.Announced a co-promotion agreement with NovaBay whereby NovaBay will promote clobetasol through its sales channels, and Eyenovia will promote NovaBay’s prescription Avenova Antimicrobial Lid & Lash Solution through its field sales force. Michael Rowe, Chief Executive Officer, commented, “During the fourth quarter and subsequent period, we continued to execute on our corporate strategy that we initiated just a few quarters ago. FDA approval of clobetasol propionate ophthalmic suspension 0.05% gives us access to a large-market indication that is complementary to Mydcombi and allows us to add additional value to eye doctors using our existing field sales force. Additionally, our recent decision to reacquire the development and commercialization rights to MicroPine expands our pipeline with a potential blockbuster drug, if approved. With the CHAPERONE study in our hands, we plan to engage with FDA later this year to explore ways to expedite its development. “At the same time, we made significant progress building out our manufacturing capabilities, with FDA approval of both our Redwood City facility as well as our contract manufacturer, Coastline International. These capabilities, together with our facility in Reno, provide us the capacity to manufacture 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, beginning with Mydcombi later this year. “We also continue to work on ways to increase uptake of Mydcombi including acceptance of our product by Vision Source, a leading group buying organization supporting optometrists throughout the United States, as well as with formulary wins at ophthalmic surgical institutions. And looking longer term, we see many opportunities to leverage the Optejet through additional collaboration and co-development agreements in high-value indications, including dry eye, which we estimate to be a three-billion-dollar annual market opportunity in the U.S. alone. “Overall, I am extremely pleased with our progress and our current momentum as we successfully transition to a commercial-stage, revenue generating leader in topical ophthalmic medications,” Mr. Rowe concluded. Fourth Quarter and Full-Year 2023 Financial Review For the fourth quarter of 2023, net loss was approximately $8.0 million, or $0.18 per share. This includes a $0.02 per share loss related to a one-time event for the repatriation of the rights to MicroPine. In 2022, our net loss was $6.1 million, or $0.17 per share, for the fourth quarter of 2022. For the full-year 2023, net loss was approximately $27.3 million, or $0.66 per share on approximately 41.0 million shares outstanding, and this compares to a net loss of $28.0 million, or $0.83 per share, on approximately 33.6 million weighted average shares outstanding, for the full year 2022. Research and development expenses totaled approximately $4.1 million for the fourth quarter of 2023, compared to $2.2 million for the fourth quarter of 2022, an increase of approximately 84.6%. For the full-year 2023, research and development expenses were $13.0 million, a decrease of 3.0% as compared to $13.4 million for the full-year 2022. The decrease was driven primarily by lower direct clinical and non-clinical expenses, as well as deferral of costs related to future delivery of clinical supply to our partners. For the fourth quarter of 2023, general and administrative expenses were approximately $3.4 million, compared to $3.2 million for the fourth quarter of 2022, an increase of approximately 7.3%. For the full-year 2023, general and administrative expenses were $12.4 million, a decrease of 8.1% as compared to $13.5 million for the full-year 2022. The full year decrease was driven by reduction in legal expenses and executive recruitment cost year over year. Total operating expenses for the fourth quarter of 2023 were approximately $7.5 million, compared to approximately $5.4 million for the fourth quarter of 2022. This represents an increase of approximately 39.0%. Total operating expenses for the full-year 2023 were $25.4 million, representing a decrease of 5.6% versus $26.9 million for the full-year 2022. As of December 31, 2023, the Company’s unrestricted cash and cash equivalents were approximately $14.8 million, as compared to $22.9 million in unrestricted and restricted cash as of December 31, 2022. Conference Call and Webcast The conference call is scheduled to begin at 4:30 pm ET today, March 18th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13744365. 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 Propionate 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.Balance Sheets December 31, 2023 2022 (unaudited) Assets Current Assets Cash and cash equivalents$14,849,057 $22,863,520 Inventories 109,798 - Deferred clinical supply costs 4,256,793 2,284,931 License fee and expense reimbursements receivable 123,833 1,183,786 Security deposits, current 1,506 119,550 Prepaid expenses and other current assets 1,365,731 1,190,719 Total Current Assets 20,706,718 27,642,506 Property and equipment, net 3,374,384 1,295,115 Security deposits, non-current 197,168 80,874 Intangible assets 2,122,945 - Operating lease right-of-use asset 1,666,718 1,291,592 Equipment deposits 711,441 726,326 Total Assets$28,779,374 $31,036,413 Liabilities and Stockholders' Equity Current Liabilities: Accounts payable$1,753,172 $1,428,283 Accrued compensation 1,658,613 1,747,191 Accrued expenses and other current liabilities 287,928 503,076 Operating lease liabilities - current portion 501,250 484,882 Notes payable - current portion, net of debt discount of $503,914 and $33,885 as of December 31, 2023 and 2022, respectively 5,329,419 174,448 Convertible notes payable - current portion, net of debt discount of $0 and $33,885 as of December 31, 2023 and 2022, respectively - 174,448 Total Current Liabilities 9,530,382 4,512,328 Operating lease liabilities - non-current portion 1,292,667 907,644 Notes payable - non-current portion, net of debt discount of $448,367 and $813,229 as of December 31, 2023 and 2022, respectively 4,355,800 4,190,938 Convertible notes payable - non-current portion, net of debt discount of $398,569 and $813,229 as of December 31, 2023 and 2022, respectively 4,601,431 4,190,938 Total Liabilities 19,780,280 13,801,848 Stockholders' Equity: Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2023 and 2022 Common stock, $0.0001 par value, 90,000,000 shares authorized; 45,553,026 and 36,668,980 shares issued and outstanding as of December 31, 2023 and 2022, respectively 4,555 3,667 Additional paid-in capital 154,486,098 135,461,361 Accumulated deficit (145,491,559) (118,230,463) Total Stockholders' Equity 8,999,094 17,234,565 Total Liabilities and Stockholders' Equity$28,779,374 $31,036,413 EYENOVIA, INC.Statements of Operations For the Three Months Ended For the Years Ended December 31, December 31, 2023 2022 2023 2022 (unaudited) (unaudited) (unaudited) Operating Income Revenue$2,589 $- $3,787 $- Cost of revenue (2,589) - (3,787) - Gross Profit - - - - Operating Expenses: Research and development 4,064,708 2,202,354 12,975,832 13,378,680 General and administrative 3,401,846 3,169,928 12,430,614 13,532,835 Total Operating Expenses 7,466,554 5,372,282 25,406,446 26,911,515 Loss From Operations (7,466,554) (5,372,282) (25,406,446) (26,911,515) Other (Expense) Income: Other (expense) income , net (18,628) 100,510 (176,411) 197,090 Interest expense (680,623) (904,247) (2,371,851) (1,380,058)Interest income 198,668 52,623 693,612 83,326 Total Other Expense (500,583) (751,114) (1,854,650) (1,099,642) Net Loss $(7,967,137) $(6,123,396) $(27,261,096) $(28,011,157) Net Loss Per Share - Basic and Diluted$(0.18) $(0.17) $(0.66) $(0.83) Shares Outstanding - Basic and Diluted 45,402,034 35,900,850 41,032,970 33,649,747

LAKE FOREST, Calif.--(BUSINESS WIRE)-- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL™) for myopia, astigmatism and presbyopia, today announced that more than three million ICLs have been sold globally.1 This press release features multimedia. View the full release here: (Graphic: STAAR Surgical) “We extend our sincere gratitude to the surgeons and clinicians with whom we partner and to their patients who have chosen our ICLs for their vision correction as we celebrate our three million lens milestone,” said Tom Frinzi, President and CEO of STAAR Surgical. “EVO ICL is the next logical step in refractive innovation with clear differentiators in patient outcomes and satisfaction. Our lens-based technology is ushering in the next generation of vision correction by helping to free patients from the struggle of daily contacts and eyeglasses.” EVO ICL is an implantable lens designed to correct a wide range of vision correction needs, including myopia with and without astigmatism, through a minimally invasive procedure. The EVO ICL lens is implanted between the iris (the colored part of the eye) and the natural crystalline lens in a quick and safe 20-30 minute procedure. It’s biocompatible and does not remove corneal tissue, so it works with the natural eye, and the lens implant is removable by a surgeon, if desired. Myopia (nearsightedness) is the most common refractive visual error and is a global epidemic that is expected to impact over half the world’s population by 2050.2 1 EVO ICL accounts for approximately 2.5 million of the 3 million total ICLs sold. 2 Ophthalmology 2016;123:1036-1042 © 2016 by the American Academy of Ophthalmology. About STAAR Surgical STAAR, which has been dedicated solely to ophthalmic surgery for over 40 years, designs, develops, manufactures and markets implantable lenses for the eye. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL,” which includes the EVO ICL™ product line. More than 3,000,000 ICLs have been sold to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: EVOICL.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA, and Nidau, Switzerland. For more information, please visit the Company’s website at . Important Safety Information for EVO ICL The EVO Visian ICL lens is intended to correct/reduce nearsightedness between -3.0 D up to -20.0 D and treat astigmatism from 1.0 D to 4.0 D. If you have nearsightedness within these ranges, EVO Visian ICL surgery may improve your distance vision without eyeglasses or contact lenses. Because the EVO Visian ICL corrects for distance vision, it does not eliminate the need for reading glasses, you may require them at some point, even if you have never worn them before. Since implantation of the EVO Visian ICL is a surgical procedure, before considering EVO Visian ICL surgery you should have a complete eye examination and talk with your eye care professional about EVO Visian ICL surgery, especially the potential benefits, risks, and complications. You should discuss the time needed for healing after surgery. Complications, although rare, may include need for additional surgical procedures, inflammation, loss of cells from the back surface of the cornea, increase in eye pressure, and cataracts. You should NOT have EVO Visian ICL surgery if your doctor determines that 1) the shape of your eye is not appropriate, 2) you do not meet the minimum endothelial cell density for your age at the time of implantation, 3) you have moderate to severe glaucoma, 4) your vision is not stable; or 5) if you are pregnant or nursing. For additional information with potential benefits, risks and complications please visit evoicl.com. View source version on businesswire.com: Contacts Investors & Media Brian Moore Vice President, Investor Relations and Corporate Development (626) 303-7902, Ext. 3023 bmoore@staar.com Source: STAAR Surgical Company Smart Multimedia Gallery Photo (Graphic: STAAR Surgical) Logo View this news release and multimedia online at:

March 13, 2024 -- NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) and Eyenovia, Inc. (Nasdaq: EYEN) announced the signing of a co-promotion agreement to commercialize prescription ophthalmic products to eyecare professionals across the U.S. Under the agreement, NovaBay will market Eyenovia’s clobetasol propionate ophthalmic suspension 0.05% (“Clobetasol”), a steroid indicated for the treatment of inflammation and pain following ocular surgery, through its U.S. physician-dispensed channel. Eyenovia will market NovaBay’s prescription Avenova® Antimicrobial Lid & Lash Solution through its Mydcombi and Clobetasol sales representatives strategically located across the U.S. Clobetasol propionate ophthalmic suspension 0.05%, developed by Formosa Pharmaceuticals, was granted U.S. Food and Drug Administration (FDA) approval on March 4, 2024, based on clinical results showing nearly nine out of ten patients achieving complete absence of post-surgical pain and six out of ten achieving total absence of inflammation within 15 days post-ocular surgery. Eyenovia acquired the U.S. commercial rights to clobetasol propionate ophthalmic suspension 0.05% from Formosa Pharmaceuticals in August 2023. Clobetasol propionate ophthalmic suspension 0.05% is expected to receive a tradename as soon as this summer. “Clobetasol propionate ophthalmic suspension 0.05% was developed to provide ophthalmologists and ocular surgery patients with a compelling, rapid, sustained and more convenient postoperative anti-inflammatory and pain relief solution. It is the first new ophthalmic steroid to enter the U.S. market in over 15 years, making it an exciting product for our physician network, and providing NovaBay with the opportunity to further leverage this channel,” said Justin Hall, CEO of NovaBay. “Our physician-dispensed channel has become increasingly important in building our Avenova business. We have found that eyecare professionals carrying our products in their offices and recommending Avenova to their patients at the time of care delivers a halo effect by stimulating online product sales.” “NovaBay has a nationwide established network of thousands of eyecare professionals through its physician-dispensed channel, thereby presenting a ready-made opportunity to complement our established salesforce and accelerate the commercialization of this product,” stated Michael Rowe, CEO of Eyenovia. “Although Avenova Antimicrobial Lid & Lash Solution has been on the market since 2015, there is considerable opportunity to generate professional awareness and grow sales. This co-promotion agreement reflects our shared commitment to bring scientifically developed, cutting-edge and high-quality ophthalmic products to physicians and the patients they treat.” Clobetasol propionate ophthalmic suspension 0.05% demonstrated successful Phase 3 clinical results in resolving inflammation and pain following ocular surgery in a rapid and sustained manner. Adverse events were infrequent, with none occurring in over 2% of patients. Clobetasol propionate ophthalmic suspension 0.05% offers a convenient dosing regimen of one drop, twice daily for two weeks, whereas most other post-surgical eye drops are dosed up to four times each day. Manufactured in the U.S., Avenova spray is formulated with NovaBay's patented, proprietary, stable and pure form of hypochlorous acid. It is clinically proven to kill a broad spectrum of bacteria to help relieve the symptoms of bacterial dry eye yet is non-irritating and completely safe for regular use. A non-prescription version of Avenova is available directly to consumers through online distribution channels such as Amazon.com and Avenova.com. 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 suspension 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/MicroLine) and myopia progression (MicroPine, both partnered with Arctic Vision in China and South Korea). NovaBay Pharmaceuticals, Inc. develops and sells scientifically created and clinically proven eyecare, skincare and wound care products. NovaBay’s leading product Avenova® Antimicrobial Lid & Lash Solution is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to consumers through online distribution channels such as Amazon.com. NovaBay also manufactures and sells effective, yet gentle and non-irritating wound care products. The PhaseOne® brand is distributed through commercial partners in the U.S. for professional use only, and the NeutroPhase® brand is distributed in China by China Pioneer Pharma Holdings, Limited. More information about NovaBay is available here. The content above comes from the network. if any infringement, please contact us to modify.