OIS XII SPONSORS
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 more than 12,000 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 www.bausch.com and connect with us on Twitter, LinkedIn, Facebook and Instagram.
Dompé is a privately-owned global bio-pharmaceutical company with 130 years of experience. We conduct research activities as part of a network of over 300 centers and universities around the globe. Dompé developed the application of rhNGF (recombinant human Nerve Growth Factor) approved by the FDA and EMA. Dompé is a leader in the research and development of innovative solutions utilizing manufactured neurotrophins for more than a decade. Neurotrophins are a family of proteins that induce the survival, development, and function of nerve cells. Nerve growth factor1 2 3 (NGF) is the first discovered member of the neurotrophin family 4. NGF, a protein naturally produced by ocular tissue, is an essential neurotrophin that induces proliferation, migration, and differentiation of corneal epithelial cells which is important in maintaining corneal integrity, sensory innervation, and overall function. NGF is often viewed as the prototype for all neurotrophins.
Genentech, a member of the Roche Group, has more than 40 years of experience in the field of biotechnology. Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA), and other retinal diseases.
Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. The Company is currently developing both therapeutic product candidates for age-related retinal diseases and gene therapy product candidates for orphan inherited retinal diseases. Vision is Our Mission. For more information on the Company, please visit www.ivericbio.com.
Stuart Therapeutics (Stuart) is a clinical stage biopharmaceutical company focused on the development of a unique tissue reparative platform for eye diseases called PolyColTM (PolyCol). PolyCol is a family of Collagen Mimetic Peptides (CMPs) that are specifically designed to repair damaged extracellular matrix (ECM) helical collagen. Helical collagen structures play an important cell signaling role in healthy tissues and they are damaged in chronic and acute/traumatic disease processes and injuries.
Stuart was founded in 2018 to champion a new approach to the treatment of chronic diseases. Each of our founders has been affected directly or indirectly by chronic eye disease, and we have a passion for the pursuit of new and effective solutions for these indications.
Stuart’s areas of interest are Dry Eye Disease, Glaucoma, and Dry Age-Related Macular Degeneration.
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures for these diseases to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary, intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. For more information, please visit www.adverum.com.
Annexin Pharmaceuticals is a public clinical stage biotech company advancing a first in class biologic with a broad therapeutic potential, ANXV (a recombinant human Annexin A5). Retinal Vein Occlusion is the primary indication in focus.
Annexin Pharmaceuticals has been given the go-ahead by FDA to start the planned proof of concept phase 2 clinical trial with the drug candidate ANXV in patients with RVO. This first limited study with ANXV in patients with recently diagnosed RVO aims to investigate safety, tolerability and efficacy related to vision and retinal function. In this patient population ANXV is to be investigated as the first in line treatment (prior to anti VEGF). The study is a placebo-controlled, double-masked, multiple-dose trial involving up to 28 patients at 6-8 eye clinics in the U.S. The overall results of the study are expected during the 4th quarter of 2022.
Annexin Pharmaceuticals management are open to looking at the full range of financial and strategic options, which could support the long-term development of our programmes.
Private company located in Cambridge MA with a proprietary nano-technology HALOS platform (High Affinity Ligands of Siglecs) with IND-ready ophthalmic lead product for geographic atrophy (GA) secondary to dry AMD (dAMD).
AVD-104, an IVT molecule with a unique dual MOA for GA on critical complement & inflammatory pathways
1. Complement pathway for GA clinically validated in Ph III trials; published research demonstrates inflammatory pathway major contributor to disease initiation and progression
2. AVD-104 demonstrated significant in-vitro/vivo efficacy with inhibition of complement & inflammatory pathways
3. Superior safety demonstrated in multiple animal models including non-human primates (NHP)
4. GLP-Tox in two species completed (80 animals) with very positive safety, ready for IND submission
5.Prevention of neovascularization compared to Eylea in well-established ocular CNV model
6- Super Pharmacokinetics with durability between Q16-24W (4-6 Months) IVT dosing regimen
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector and strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. Clearside’s first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, is commercially available in the U.S.
Lexitas Pharma Services
Lexitas is a 140-person company which partners with pharmaceutical firms to develop novel eye care drugs by running clinical trials.
Founded in 2011, it operates from Durham, North Carolina and has expertise in both anterior and posterior segments of ophthalmology. These include dry eye syndrome; meibomian gland dysfunction; blepharitis; bacterial, viral and allergic conjunctivitis; glaucoma; macular degeneration and diabetic macular edema.
LumiThera, Inc. is a medical device company commercializing a multi-wavelength instrument for the ophthalmologist’s office that improves vision and slows the progression of vision loss in patients with degenerative eye disease. The Company’s focus to date has been on the treatment of patients with dry age-related macular degeneration (AMD). The Company has significant expertise in the use of Photobiomodulation (PBM), which is the use of light therapy to stimulate cells using light emitting diodes (LEDs) of selected wavelengths. The company has just released topline data from the LIGHTSITE III US pivotal trial demonstrating a statistically significant improvement in BCVA in intermediate dry AMD subjects meeting the 13M primary endpoint with sustained benefit.
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.
EyeSol® is Novaliq’s proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of patients with eye diseases. The company has recently announced filing New Drug Applications (“NDA”) to the Food and Drug Administration (“FDA”) for their investigational dry eye disease drug therapies, NOV03 and CyclASol®.
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 www.novaliq.com.
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology. Our robust product pipeline positions Ocular Therapeutix to become a leader in the ophthalmic space due to our ability to create drug delivery solutions that reduce the complexity and burden of the current standard of care by developing sustained release alternatives. With a focus on advancing our products through to Phase 3 clinical trials, our intention is to develop a commercially viable portfolio to overcome the issues of patient compliance and adherence by providing means of more consistent and reliable drug dosing for better patient outcomes.
Ocuphire Pharma is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders.Our pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications.
Nyxol® Eye Drops
Nyxol is being developed for several indications including pharmacologically-induced mydriasis, presbyopia, and dim light or night vision disturbances.
Nyxol is an investigational 505(b)(2) product candidate that has been studied in over 650 subjects across 12 completed Phase 1, 2, and 3 trials.
Our second product candidate, APX3330, is a twice-a-day oral tablet designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy and diabetic macular edema.
APX3330 has been studied in over 340 patients across six Phase 1 and five Phase 2 trials.
ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to protecting and improving the vision of patients with retinal disease. By advancing a breakthrough technology designed to protect key retinal cells from Fas-mediated cell death, ONL is pioneering a new approach to preserving vision. ONL is developing a platform of products for use in a wide range of blinding diseases, including retinal detachment, glaucoma, AMD and IRD. ONL1204, the Company's lead compound, is currently being used in three Phase 1b studies in the indications of retinal detachment, Geographic Atrophy and Open Angle Glaucoma. The Company is preparing to enter Phase 2 studies in the same indications.
Outlook Therapeutics is a pre-commercial biopharmaceutical company working to develop and launch ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. Outlook Therapeutics submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ONS-5010 to treat wet AMD on March 30, 2022. After conversations with the FDA about its filing, the Company has voluntarily withdrawn the BLA as it works to provide supplemental information that the FDA has requested. Outlook Therapeutics remains in active discussions with the FDA and expects to resubmit the BLA by September 2022. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, Greater China and other markets. Outlook Therapeutics’ BLA submission for ONS-5010 is as a new BLA under the PHSA 351(a) regulatory pathway.
If ONS-5010 is approved, the Company expects to commercialize it through best-in-class partnerships. To date, Outlook Therapeutics has manufacturing partnerships with Fujifilm Diosynth Biotechnologies and Ajinomoto Biopharma Services to provide product manufacturing in their best-in-class cGMP global manufacturing facilities.
Outlook Therapeutics has also executed a supply agreement for a best-in-class pre-filled ophthalmic syringe that will provide both ease-of-use for clinicians and add to ONS-5010’s potential safety profile over the current unapproved therapies that have caused problems related to syringe malfunction, contamination, etc.
Outlook Therapeutics intends to create goodwill and acceptance among payors, retinal specialists and patients by offering excellent value in an FDA-approved ONS-5010.
Regeneron is a leading biotechnology company that invents life-transforming medicines for serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly translate science into medicine has led to numerous FDA-approved treatments and product candidates in development. Visit www.Regeneron.com to learn more.
Trefoil Therapeutics is a clinical stage company focused on the application of novel engineered FGF-1 compounds in underserved ophthalmic disease areas. The lead indication is Fuchs Dystrophy, a disease that is currently treated with corneal transplantation. Trefoil has completed a phase 2 study for the intracameral injectable formulation for the treatment of Fuchs Dystrophy and will initiate a phase 1 study for the topical epithelial indication for the treatment of ulcerative conditions of the cornea 2022.