Eye Burns

Scientists have produced an organoid model of the human conjunctiva. These organoids mimic the function of the actual human conjunctiva, a tissue involved in tear production. Using their new model, the researchers discovered a new cell type in this tissue: tuft cells. The tuft cells become more abundant under allergy-like conditions and are therefore likely to play a role in allergies. The organoid model can now be used to test drugs for several diseases affecting the conjunctiva. The Organoid group at the Hubrecht Institute produced the first organoid model of the human conjunctiva. These organoids mimic the function of the actual human conjunctiva, a tissue involved in tear production. Using their new model, the researchers discovered a new cell type in this tissue: tuft cells. The tuft cells become more abundant under allergy-like conditions and are therefore likely to play a role in allergies. The organoid model can now be used to test drugs for several diseases affecting the conjunctiva. The study will be published in Cell Stem Cell on 11 January 2024. Our eyes produce tears to protect themselves from injuries and infections. The conjunctiva, a tissue that covers the white of the eye and the inside of the eyelids, is partially responsible for the production of these tears. It participates in tear production through the release of mucus. This mucus allows the tears to stick to the ocular surface and protects it from pathogens. Limited treatment options Several diseases and disorders affect the conjunctiva, such as dry eye disease, cancer, allergies and infections. In severe cases, disfunction of this tissue can lead to blindness. Until now, there has not been a good model of the human conjunctiva, which limits research into its function in sickness and in health. Consequently, there are limited treatment options for diseases affecting the conjunctiva. First model To gain more insight into the composition and functioning of the conjunctiva, the Organoid group set out to develop the first human model of this type of tissue. They used cells from an actual human conjunctiva and grew them into 3D structures in a dish. These miniature structures are called organoids and function as real human conjunctiva. “Once we had these functioning organoids, we wanted to know how the conjunctiva is involved in the production of tears,” Marie Bannier-Hélaouët, lead researcher in the project, explains. “We discovered that the conjunctiva makes antimicrobial components and therefore contributes to tear production in more ways than by simply making mucus.” Allergies The researchers then altered the conditions in the dish with the miniature conjunctivae to mimic allergies. “The organoids started to produce completely different tears: there was more mucus but there were also more antimicrobial components,” says Bannier-Hélaouët. Under these conditions, they also found a new cell type in the organoids: tuft cells. Bannier-Hélaouët continues: “Similar cells have been discovered in other tissues, but not in the human conjunctiva.” The tuft cells became more abundant under the allergy-like conditions, suggesting they play a role in the eye’s reaction to allergies. Drugs The newly developed organoid model opens the door for research into diseases affecting the conjunctiva. “We can use our model to test drugs for allergies or dry eye disease, for example,” says Bannier-Hélaouët. In the long term, it may even be possible to make replacement conjunctivae for people with ocular burns, ocular cancers or maybe even genetic disorders. “We are now running preclinical studies in rabbits to assess whether this approach is feasible and helpful,” Bannier-Hélaouët concludes.

- Fluorometholone Ophthalmic Suspension, USP, 0.1% - Product has 180-day competitive generic therapy exclusivity BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension. The product received 180-day competitive generic therapy (CGT) exclusivity from the U.S. Food and Drug Administration, a status that applies to first-marketed generics of key medicines. FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. “We are starting the new year with the launch of another complex high-value product, which will help drive our continued growth,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “Ophthalmic products represent a less crowded and more durable category, and we continue to expand our portfolio of affordable medicines.” Adverse drug events reported with the use of fluorometholone ophthalmic suspension 0.1% include short term inflammatory eye reactions such as eye and eyelid swelling, redness, burning eye pain, itchy eyes; and long-term use effects including elevation of intraocular pressure (IOP) with possible development of glaucoma, infrequent optic nerve damage, cataract formation, vision problems, and delayed eye wound healing. For full prescribing information, see package insert located here. According to IQVIA®, U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million. About Amneal Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). 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Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction NOV03 PDUFA Action Date is June 28, 2023 VAUGHAN, Ontario & HEIDELBERG, Germany--(BUSINESS WIRE)-- Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a leading global eye health company dedicated to helping people see better to live better, and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in class ocular therapeutics, today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Results from the first pivotal Phase 3 trial, GOBI, were published earlier this year in Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023. “In addition to meeting both primary sign and symptom efficacy endpoints, NOV03 was shown to be very well tolerated in the MOJAVE study. These are all critical factors that must be considered when determining a treatment plan for someone with a chronic and progressive condition like dry eye disease associated with Meibomian gland dysfunction,” said Yehia Hashad, M.D., executive vice president, Research & Development and chief medical officer, Bausch + Lomb. “Excess tear evaporation is a major factor in dry eye disease associated with Meibomian gland dysfunction, which remains largely unaddressed.” “Currently there are no FDA-approved prescription therapies available which directly target evaporation, leaving patients with limited treatment options,” said Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb. “These data are consistent with the results seen in the first Phase 3 trial, and further support NOV03 as a new potential therapy designed to alleviate the signs and symptoms of dry eye disease associated with Meibomian gland dysfunction.” DED affects millions of Americans and is one of the most common ocular surface disorders.1 MGD is a major cause of development and disease progression, affecting approximately nine out of 10 people with DED.2,3 DED due to MGD is caused by a deficient tear film lipid layer that leads to increased tear evaporation.4 There is currently no approved prescription eye drop in the United States indicated for DED associated with MGD. “This is a year of exciting milestones for NOV03, with the publication of both sets of pivotal Phase 3 data, anticipated new topline data expected later this year from the KALAHARI 12 month safety extension trial, and the PDUFA action date in June,” said Christian Roesky, Ph.D., CEO, Novaliq. “We look forward to continuing to work closely with Bausch + Lomb to advance NOV03 as a potential new treatment option, which, if approved, will help to address the needs of millions of Americans who suffer from dry eye disease associated with Meibomian gland dysfunction.” About the MOJAVE Study The data from the Phase 3, multicenter, randomized, hypotonic saline-controlled, double masked MOJAVE study was based on results from 620 subjects aged 18 years and older who were randomized to either receive treatment with NOV03 four times daily or hypotonic saline solution four times daily (n=311 NOV03; n=309 saline). The two primary endpoints were change from baseline at Week 8 (Day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. Key secondary endpoints included change from baseline in eye dryness VAS score and tCFS at Week 2 (Day 15 ± 1) and eye burning/stinging VAS score and central corneal fluorescein staining (cCFS) at Week 8. Significant improvements vs. hypotonic saline solution were seen as early as day 15. Data highlights include: Primary endpoints At Week 8, reduction from baseline in tCFS was statistically greater in the NOV03 arm compared to the control saline group (least-squares [LS] mean treatment difference, -1.2 (95% confidence interval [CI]: -1.7, -0.8) (P < .001)). At Week 8, VAS dryness score was statistically significantly improved in the NOV03 arm compared to control group (LS mean treatment difference, -10.2 (95% CI: -14.4, -6.1) (P < .001)). Key secondary endpoints At Week 2, tCFS and VAS dryness score were statistically significant compared to saline, with an LS mean treatment difference (95% CI) for change from baseline in tCFS of -0.6 (-1.0, -0.2) (P = .001) and VAS score of -7.8 (-11.3, -4.3) (P < .001). At Week 8 VAS burning/stinging score and cCFS also favored the NOV03 group, with an LS mean treatment difference (95% CI) for change from baseline in VAS burning/stinging score of -7.3 (-11.3, -3.4) (P < .001) and cCFS of -0.3 (-0.5, -0.2) (P < .001). In the study, NOV03 was well tolerated with few subjects experiencing ocular adverse events (AEs) (12.9% NOV03 group, 12.3% control group) or treatment-related ocular AEs (6.4% NOV03 group, 6.8% control group). Most AEs were mild to moderate in severity. The most common AEs (incidence ≥ 1%) experienced in the NOV03 group were blepharitis, conjunctival hyperemia, conjunctival papillae, ocular hyperemia, blurred vision, hordeolum (stye), and visual acuity reduction. No patients in either the NOV03 group or saline group had an ocular AE that led to treatment discontinuation or withdrawal from the study. About NOV03 (perfluorohexyloctane) Ophthalmic Solution NOV03 is an investigational, proprietary, water-free, single-component preservative-free eye drop.5 In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada. Results from the pivotal Phase 2 trial (SEECASE) were published in Cornea in September 2021. Data from the first pivotal Phase 3 trial (GOBI) were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C. on April 24, 2022. Data from the second pivotal Phase 3 trial (MOJAVE) were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022. The clinical program for NOV03 concluded with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI). In September 2022, Bausch + Lomb and NOV03 announced that the U.S. FDA had accepted the NDA filing for NOV03 and assigned a PDUFA action date of June 28, 2023. About Novaliq Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an active investor in Life and Health Sciences companies. More on . About Bausch + Lomb Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit and connect with us on Twitter, LinkedIn, Facebook and Instagram. Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch + Lomb, including but not limited to its project development timelines, launches and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. _______________________________ References National Eye Institute. Dry Eye. Last updated April 8, 2022. Accessed December 21, 2022. Leonardi, A., Modugno, R. L., & Salami, E. (2021). Allergy and Dry Eye Disease. Ocular immunology and inflammation, 29(6), 1168-1176. . Lemp, MA, Crews, LA, Bron AJ. (2012). Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Patient Cohort: a retrospective study. Cornea, 31(5), 472-478. Geerling G, Baudouin C, Aragona P, et al. (2017). Emerging strategies for the diagnosis and treatment of meibomian gland dysfunction: Proceedings of the OCEAN group meeting. The Ocular Surface,15(2): 179-192. In December 2019, Bausch Health acquired the rights from Novaliq GmbH to pursue development and commercialization of NOV03 for DED and combination products based on NOV03 in additional ophthalmic indications in the United States and Canada. All product/brand names and/or logos are trademarks of the respective owners. © 2023 Bausch & Lomb Incorporated or its affiliates. NOV03.0004.USA.23 V2