Facial Injuries

PITTSBURGH, April 1, 2024 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced the U.S. commercial launch of RYZUMVI™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents in the United States. RYZUMVI is now the only U.S. commercially available FDA-approved eye drop to reverse dilation.1 According to the American Academy of Ophthalmology and the American Optometric Association, clinical practice guidelines recommend dilation as a standard of care.2,3 Dilation allows eye care professionals to identify both common and serious eye health issues, including signs of systemic disease.2,3 The average time of dilation lasts three to eight hours, but can last up to 24 hours in some people.4,5 Prolonged dilation may lead to patients refusing dilation.6,7 Comprehensive dilated eye exams play a vital role in detecting potential vision-impairing ophthalmic conditions such as cataracts and potentially blinding diseases like glaucoma, diabetic retinopathy, and age-related macular degeneration.2,3 Additionally, comprehensive dilated eye exams can uncover evidence of systemic diseases like diabetes, rheumatoid arthritis, and hypertension.2,3 The U.S. Food and Drug Administration (FDA) approved RYZUMVI in September 2023. RYZUMVI was evaluated across 2 randomized, vehicle-controlled, double-masked MIRA-2 and MIRA-3 clinical trials in which patients (N=553) aged 12 to 80 years who had mydriasis induced by instillation of phenylephrine, tropicamide, or PAREMYD® (hydroxyamphetamine hydrobromide and tropicamide) were administered 2 drops (in the study eye) or 1 drop (in the fellow eye) of either RYZUMVI or placebo one hour after instillation of the mydriatic agent. The onset of action of RYZUMVI generally occurs in 30 minutes. In the MIRA-2 and MIRA-3 clinical trials, at 90 minutes after administration, 49% and 58% of patients administered 2 drops of RYZUMVI returned to ≤ 0.2 mm of baseline pupil diameter compared to 7% and 6% of patients administered placebo, respectively. In the MIRA-2 trials' placebo group, 34% of patients were still dilated (had not returned to ≤ 0.2 mm of baseline pupil diameter) at 24 hours. In the MIRA-3 trials' placebo group, 28% of patients were still dilated at 24 hours.1 RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis). To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses.1 The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). For more information on RYZUMVI, visit . About Pharmacologically-Induced Mydriasis An estimated 100 million eye dilations are conducted every year in the U.S. to examine the retina (back-of-the-eye) either for routine check-ups, disease monitoring or surgical procedures.8 Recovery from pharmacologically-induced mydriasis can take three to eight hours, and sometimes lasts 24 hours.4,5 About RYZUMVI ™ (Phentolamine Ophthalmic Solution) 0.75% Indication RYZUMVI™ (phentolamine ophthalmic solution) 0.75% is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents. Important Safety Information Warnings and Precautions Uveitis: RYZUMVI is not recommended to be used in patients with active ocular inflammation (e.g., iritis). Potential for Eye Injury or Contamination: To avoid the potential for eye injury or contamination, care should be taken to avoid touching the vial tip to the eye or to any other surface. Use with Contact Lenses: Contact lens wearers should be advised to remove their lenses prior to the instillation of RYZUMVI and wait 10 minutes after dosing before reinserting their contact lenses. Adverse Reactions The most common adverse reactions that have been reported are instillation site discomfort (16%), conjunctival hyperemia (12%), and dysgeusia (6%). Click here for full Prescribing Information. Forward Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements regarding the U.S. commercial launch of RYZUMVI™ in the United States and that RYZUMVI is now the only U.S. commercially available FDA-approved eye drop to reverse dilation. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility that Viatris may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that Viatris may be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets; Viatris' failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Contacts: Media: +1.724.514.1968 [email protected] Jennifer Mauer [email protected] Matt Klein [email protected] Investors: +1.724.514.1813 [email protected] Bill Szablewski [email protected] SOURCE Viatris Inc.

-- Advancing ongoing Phase 2b CHASE trial of KPI-012 for PCED; topline data targeted by year-end 2024 ---- Exploring opportunities to expand KPI-012 into additional corneal indications ---- Cash resources as of December 31, 2023, together with proceeds from the March 2024 private placement and anticipated funding remaining from CIRM award, expected to fund operations into 3Q 2025 -- ARLINGTON, Mass., March 29, 2024 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update. “In 2023, we focused on clinical execution, advancing our Phase 2b CHASE trial of KPI-012 for the treatment of PCED. In March 2023, we announced positive safety data from the first cohort of patients, reinforcing the promising safety and tolerability profile of high dose KPI-012, and allowing us to progress into the multicenter, randomized, double-masked efficacy cohort, which we are targeting to read out by year-end 2024,” said Mark Iwicki, Chair and Chief Executive Officer of KALA BIO. “Based on its multifactorial mechanism of action, we believe KPI-012 may address a significant unmet need, potentially offering patients and physicians a highly differentiated product profile and the first therapy for PCED that addresses the multiple underlying etiologies of the disease. We look forward to topline data from the CHASE trial, as we work to establish KPI-012 as a safe, well-tolerated, easily administered and effective treatment for the nearly 100,000 patients living with PCED in the U.S.” Fourth Quarter and Recent Business Highlights: Development-Stage Pipeline:KALA is advancing an innovative pipeline based on its proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA believes the multifactorial mechanism of action of its MSC-S platform technology may enable it to generate products for a range of ocular orphan diseases and is evaluating the potential development of this technology for multiple rare, front- and back-of-the-eye diseases. KPI-012 combines growth factors, protease inhibitors, matrix proteins and neurotrophic factors to potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KALA is initially developing KPI-012 for the treatment of persistent corneal epithelial defect (PCED), a persistent, non-healing corneal defect or wound that is refractory to conventional treatments which, if left untreated, can lead to significant complications, including infection, corneal perforation/scarring and vision loss. PCED has an estimated incidence of approximately 100,000 patients in the U.S. and represents a sizeable market opportunity; there are currently no U.S. Food and Drug Administration (FDA)-approved prescription products with a broad indication for all underlying etiologies of PCED. KALA is actively enrolling patients in the primary safety and efficacy portion of the CHASE (Corneal Healing After SEcretome therapy) Phase 2b clinical trial evaluating KPI-012 for the treatment of PCED and is targeting to announce topline data by year-end 2024.If the results are positive, and subject to discussion with regulatory authorities, KALA believes the CHASE Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a Biologics License Application (BLA) to the FDA. KALA is also evaluating the potential of KPI-012 for additional rare, front-of-the-eye diseases, such as Limbal Stem Cell Deficiency (LSCD) and other corneal diseases that threaten vision. LSCD is characterized by the loss or deficiency of limbal epithelial stem cells, which can result in recurrent epithelial breakdown, neovascularization, conjunctivalization, inflammation and other sequalae that can lead to loss of corneal clarity and vision impairment. Like PCED, LSCD represents a substantial market opportunity, with an estimated incidence of 100,000 patients in the U.S. KPI-014, KALA’s preclinical program to evaluate the utility of its MSC-S platform for inherited retinal degenerative diseases, contains neurotrophic factors, growth factors, anti-inflammatory or immune-modulatory factors and antioxidant inhibitors with the potential to protect and preserve retinal cell function. Secretomes have demonstrated a neuroprotective effect in both in vitro and in vivo models of retinal degeneration. KALA believes KPI-014 could offer a gene-agnostic approach for the treatment of rare inherited retinal diseases and has initiated preclinical studies to evaluate the utility of KPI-014 for conditions such as Retinitis Pigmentosa and Stargardt Disease. Corporate:In December 2023 and March 2024, KALA announced private placement financings with an institutional investor, priced at-the-market under Nasdaq rules. Aggregate gross proceeds from the financings were approximately $2.0 million and $8.6 million, respectively. Financial Results: Cash Position: As of December 31, 2023, KALA had cash and cash equivalents of $50.9 million, compared to $56.1 million as of September 30, 2023. This decrease reflects cash used in operations and gross proceeds of $2.0 million received from KALA’s December 2023 private placement financing. Based on its current plans, KALA anticipates that its cash resources as of December 31, 2023, together with gross proceeds of $8.6 million received from its March 2024 private placement financing and anticipated funding under the CIRM award, will enable it to fund operations into the third quarter of 2025. Financial Results for the Three Months Ended December 31, 2023: SG&A Expenses: For the quarter ended December 31, 2023, selling, general and administrative (SG&A) expenses were $4.6 million, compared to $5.8 million for the same period in 2022. The decrease was primarily due to the sale of KALA’s commercial portfolio to Alcon Inc. (Alcon) in July 2022.R&D Expenses: For the quarter ended December 31, 2023, research and development (R&D) expenses were $4.7 million, compared to $3.3 million for the same period in 2022. The increase was primarily due to an increase in KPI-012 development costs and employee-related costs.Loss on Fair Value Remeasurement of Deferred Purchase Consideration: There was no gain or loss on fair value remeasurement of deferred purchase consideration, in connection with the acquisition of Combangio, for the quarter ended December 31, 2023 due to the settlement of the liability in March 2023. The loss on fair value remeasurement of deferred purchase consideration was $0.4 million for the same period in 2022.Loss on Fair Value Remeasurement of Contingent Consideration: For the quarter ended December 31, 2023, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.3 million, compared to a loss of $0.7 million for the same period in 2022.Operating Loss: For the quarter ended December 31, 2023, loss from operations was $9.6 million, compared to $10.3 million for the same period in 2022.Net Loss: For the quarter ended December 31, 2023, net loss was $8.6 million, or $3.18 per share, compared to a net loss of $12.8 million, or $7.97 per share, for the same period in 2022. The weighted average number of shares used to calculate net loss per share was 2.7 million for the quarter ended December 31, 2023, and 1.6 million for the quarter ended December 31, 2022. Financial Results for the Full Year Ended December 31, 2023: Net Product Revenues: KALA did not recognize product revenues in the full year ended December 31, 2023 as a result of the sale of its commercial portfolio to Alcon in July 2022. For the full year ended December 31, 2022, Kala reported net product revenues of $3.9 million.Cost of Product Revenues: KALA did not record cost of product revenues in the full year ended December 31, 2023 as a result of the sale of its commercial portfolio to Alcon in July 2022. For the full year ended December 31, 2022, cost of product revenues was $2.6 million.SG&A Expenses: For the full year ended December 31, 2023, SG&A expenses were $20.6 million, compared to $65.0 million for the same period in 2022. The decrease was primarily due to the sale of KALA’s commercial portfolio to Alcon.R&D Expenses: For the full year ended December 31, 2023, R&D expenses were $18.6 million, compared to $17.7 million for the same period in 2022. The increase was primarily due to an increase in KPI-012 development costs and employee-related costs, partially offset by a decrease in other research and development costs, which primarily included preclinical studies related to KALA’s former pipeline programs and facility related costs.(Gain) Loss on Fair Value Remeasurement of Deferred Purchase Consideration: For the full year ended December 31, 2023, the gain on fair value remeasurement of deferred purchase consideration, in connection with the acquisition of Combangio, was $0.2 million, compared to a loss of $0.6 million for the same period in 2022.Loss (Gain) on Fair Value Remeasurement of Contingent Consideration: For the full year ended December 31, 2023, the loss on fair value remeasurement of continent consideration, in connection with the Combangio acquisition, was $0.7 million, compared to a gain of $0.3 million for the same period in 2022.Operating Loss: For the full year ended December 31, 2023, loss from operations was $39.7 million, compared to $81.7 million for the same period in 2022.Loss on Extinguishment of Debt: For the full year ended December 31, 2023, KALA did not report a loss on extinguishment of debt, compared to a loss of $2.6 million in the same period in 2022 as a result of a partial prepayment of outstanding principal and related fees under its loan agreement with Oxford Finance LLC in connection with the closing of the sale of its commercial business to Alcon.Gain on Sale of Commercial Business: For the full year ended December 31, 2023, KALA did not report a gain on sale of commercial business, compared to a gain of $47.0 million for the same period in 2022 related to the sale of its commercial business to Alcon.Net Loss: For the full year ended December 31, 2023, net loss was $42.2 million, or $17.35 per share, compared to a net loss of $44.8 million, or $29.48 per share, for the same period in 2022. The weighted average number of shares used to calculate net loss per share was 2.4 million for the full year ended December 31, 2023, and 1.5 million for the full year ended December 31, 2022. About KALA BIO, Inc. KALA is a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye. KALA’s biologics-based investigational therapies utilize KALA’s proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA’s lead product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. KPI-012 is currently in clinical development for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing, for which it has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. KALA is also targeting the potential development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases that threaten vision and has initiated preclinical studies to evaluate the potential utility of its MSC-S platform for retinal degenerative diseases, such as Retinitis Pigmentosa and Stargardt Disease. For more information on KALA, please visit www.kalarx.com. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Any statements in this press release about KALA’s future expectations, plans and prospects, including but not limited to statements about KALA’s expectations with respect to potential advantages of KPI-012 and its MSC-S platform; the clinical utility of KPI-012 for PCED; anticipated timelines to report topline data for the CHASE Phase 2b clinical trial of KPI-012; KALA’s belief that the Chase Phase 2b trial could serve as the first of two pivotal trials required to support the submission of a BLA to the FDA; KALA’s plans to pursue research and development of KPI-012 and its MSC-S platform for other indications; expectations about the potential benefits and future operation of the CIRM award; KALA’s ability to achieve the specified milestones and obtain the full funding under the CIRM award; the sufficiency of KALA’s existing cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: KALA’s ability to comply with the requirements under the CIRM award; uncertainties inherent in the initiation and conduct of preclinical studies and clinical trials; uncertainties regarding availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the Phase 1b clinical trial of KPI-012 will be indicative of results for any future clinical trials and studies of KPI-012, including the CHASE Phase 2b clinical trial; whether interim data from a clinical trial will be predictive of the results of the trial; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; KALA’s ability to retain and hire key personnel; KALA’s ability to comply with the covenants under its loan agreement, including the requirement that its common stock continue to be listed on The Nasdaq Stock Market; the sufficiency of cash resources and need for additional financing and other important factors, any of which could cause KALA’s actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of KALA’s Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other filings KALA makes with the Securities and Exchange Commission. These forward-looking statements represent KALA’s views as of the date of this press release and should not be relied upon as representing KALA’s views as of any date subsequent to the date hereof. KALA does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Financial Tables: KALA BIO, Inc.Balance Sheet Data(in thousands)(unaudited) December 31, December 31, 2023 2022Cash and cash equivalents $50,895 $70,495Total assets 55,949 86,820Working capital(1) 44,524 60,257Long-term debt, net of discounts 34,190 37,937Other long-term liabilities 5,909 4,224Total stockholders’ equity 7,504 18,974 (1) The Company defines working capital as current assets less current liabilities. See the Company's consolidated financial statements for further information regarding its current assets and current liabilities. KALA BIO, Inc.Consolidated Statement of Operations(In thousands, except share and per share data)(Unaudited) Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 Product revenues, net $— $— $— $3,892 Costs and expenses: Cost of product revenues — — — 2,560Selling, general and administrative 4,623 5,831 20,567 65,035Research and development 4,718 3,323 18,586 17,653Loss (gain) on fair value remeasurement of deferred purchase consideration — 433 (230) 638Loss (gain) on fair value remeasurement of contingent consideration 278 664 740 (288)Total operating expenses 9,619 10,251 39,663 85,598Loss from operations (9,619) (10,251) (39,663) (81,706)Other income (expense): Interest income 610 354 2,711 664Interest expense (1,468) (1,577) (5,814) (7,266)Grant income 1,855 — 4,825 —Loss on extinguishment of debt — — — (2,583)Gain on sale of commercial business — — — 46,995Other income (expense), net (5) (1,369) (4,258) (926)Total other income (expense) 992 (2,592) (2,536) 36,884Net loss $(8,627) $(12,843) $(42,199) $(44,822)Net loss per share attributable to common stockholders—basic and diluted $(3.18) $(7.97) $(17.35) $(29.48)Weighted average shares outstanding—basic and diluted 2,712,475 1,611,375 2,432,008 1,520,611 Investor Contact:Hannah Deresiewiczhannah.deresiewicz@sternir.com212-362-1200

The campaign is aimed at raising awareness around the medical benefits of masturbation and orgasm, especially for those going through menopause, who may see symptoms like vaginal dryness and atrophy improve from the blood flow-boosting “vibrational therapy" of MysteryVibe's devices. It’s no mystery who’s responsible for the first-ever billboards in the U.S. to show a vibrator: Sexual health devicemaker MysteryVibe has claimed credit for the ads, with an assist from healthcare marketing agency Havas Lynx. As part of its “Happy Menopause” campaign, MysteryVibe’s bold billboards are emblazoned with the slogan, “Orgasm now comes with a medical prescription,” overlaid on a picture of the company’s Crescendo 2 device. Finer print dotting the posters notes that MysteryVibe offers “the only HSA/FSA eligible intimacy devices,” directs them to MysteryVibe’s website and shares the “#happymenopause” tag. The billboards went up Monday in central Manhattan, where they’ll stay for a week, closing out Women’s History Month, according to Havas’ announcement this week. “Women’s sexual well-being and pleasure remains a whispered subject—especially when you add menopause into the mix,” said Shared Tash Loeb Mills, the agency’s director of planning. “We’ve had enough of it, and what better way to get people talking, than with a massive orgasm! That’s what everyone wants, after all.” Rounding out the “Happy Menopause” campaign are additional educational materials, backed by research from Joyce Harper, Ph.D., a professor of reproductive science at University College London’s Institute for Women’s Health. The campaign is aimed at raising awareness around the medical benefits of masturbation and orgasm, especially for those going through menopause, who may see symptoms like vaginal dryness and atrophy improve from the blood flow-boosting “vibrational therapy” of the Crescendo 2, according to Havas’ release. “We are incredibly lucky to have been a part of many ‘firsts’ in women’s health over the past decade,” MysteryVibe CEO Soumyadip Rakshit said in the announcement. “Not only are we honored to support a campaign that enables women to overcome taboos around menopause, we know that discomfort shouldn’t be normalized.” The “Happy Menopause” campaign follows another menopause-focused push from MysteryVibe that went live late last year and included billboards—sans photos of the company’s devices—with slogans like, “A menopause prescription you’ll be happy to take. Over and over again.” MysteryVibe markets its vibrators as being rooted in medical research and among the few sex toys to be registered with the FDA as medical devices. Studies published in the Journal of Sexual Medicine around the Crescendo 2, for example, show that using the device resulted in a fivefold improvement in pain scores for women with genito-pelvic pain/penetration disorder and that it can also significantly improve symptoms of female sexual arousal disorders when used in combination with cognitive behavioral therapy.