OIS XII PRESENTING COMPANIES
Laurent Fischer, MD, President & CEO - Adverum Biotechnologies
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.
Anna Frostegaard, MD, PhD, Chief Scientific and Medical Officer - Annexin Pharmaceuticals
Annexin Pharmaceuticals is a publicly listed (NASDAQ/First North, Sweden) clinical stage biotech company advancing ANXV (a human recombinant protein Annexin A5 ), a first-in-class biologic with a broad therapeutic potential.
Retinal Vein Occlusion is the primary indication in focus. Here ANXV has a potential to become a first in line /first in class treatment for patients with recently diagnosed RVO prior to anti VEGF treatment. The mode of action is non-overlapping to the current standard of care anti-VEGF.
ANXV has completed a Phase 1 trial and demonstrated favorable safety and tolerability profile. The Phase 2 clinical trial in Retinal Vein Occlusion is approved by the FDA and is currently enrolling in the USA. The data is expected Q2 2023.
Currently, Annexin Pharma is in collaboration with Tracer Inc (The Netherlands) for an imaging study with labeled ANXV in patients with eye disease including RVO (enrolling) and with the University Hospital in Maastricht ( The Netherlands) for a trial in patients with moderate to severe COVID-19.
The CMC process is optimized and is being prepared for commercial upscaling.
The IP portfolio is strong with the key patents recently issued in major territories.
Annexin Pharmaceuticals management are open to looking at the full range of strategic options that would facilitate long term development.
Jon Robson, President & CEO - Avellino
Avellino creates new opportunities to improve health through the science and technology of genomics. Using artificial intelligence, molecular diagnostics and data aggregation, Avellino is accelerating precision health to better manage inherited diseases. AvaGen™, the world’s first genetic diagnostic tool for corneal disease, provides a universal platform for next-generation genetic sequencing across a broad spectrum of diseases. Avellino is headquartered in Silicon Valley, California, with operations in Korea, Japan and the UK. To learn more about Avellino, please visit avellino.com.
Michael Tolentino, MD, Vitreoretinal Surgeon & Chief Technology Officer - Aviceda Therapeutics
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
Rui Jing Jiang, CEO, Co-founder, and Director - Avisi
Founded in March 2017, Avisi is a medical device company developing VisiPlate®, a nanotechnology-enabled ocular implant for treating glaucoma. Open-angle glaucoma (OAG) is a leading cause of irreversible blindness in the world and has no cure.
VisiPlate® is a multichannel, ultrathin, and nonfibrotic drainage implant that creates a new outflow pathway for the aqueous humor in the eye. VisiPlate’s unique scale and mechanism of action are meant to translate to greater safety, efficacy, and savings for patients and stakeholders. The underlying nanotechnology in VisiPlate is a shape-recovering, plate metamaterial developed at the University of Pennsylvania. Hexagonal microstructures in the material give VisiPlate the flexural strength to be manually handled by surgeons, unlike other delicate nano-films that crumple. Moreover, VisiPlate’s unique shape-recovery properties enable it to withstand bending. These properties facilitate minimally invasive surgery and improve patient quality of life.
Marc Gleeson, CEO - Azura Ophthalmics
At Azura Ophthalmics, we are utilizing our deep understanding of ocular surface diseases and drug development to deliver a new therapeutic class of Ophthalmic Keratolytics to treat underserved ophthalmic conditions. Our goal is to change the paradigm for the treatment of ophthalmic conditions by delivering First-in-Class Ophthalmic Keratolytics. Harnessing the power of keratolytics for lid margin and ocular surface diseases. Treating the core pathophysiology to improve signs, symptoms, and burden of ophthalmic conditions.
Barry Butler, President & CEO - Betaliq
Betaliq, Inc. is developing topical medications for glaucoma formulated in Novaliq's novel water-free EyeSol® technology. Features of this technology include: does not require a preservative, cornea sparing vehicle, micro-drop delivery (11 mcl drop size), increased residence time on the ocular surface, and enhanced absorption.
Betaliq has completed a large phase 2 trial of our first product, BTQ-1902. BTQ-1902 will be entering Phase 3 in 1H/2023. Additional products are scheduled to enter Phase 2 trials in 2023.
David Almeida, MD, MBA, PhD, Vitreoretinal Surgeon & Cofounder - Citrus Therapeutics
Citrus Therapeutics, LLC is a U.S. company based in Riverside, California, and was formed to develop, research, and promote innovative muti-pharmacophore therapies.
Citrus Therapeutics is an early leader in novel multi-pharmacophore agents for AMD and recently announced that the U.S. Patent Office had issued Patent Application No. 17/837,917 for the “Therapeutic Agent for Treatment of Age-Related Macular Degeneration” and for the registration of CTZ1, the first-of-its-kind vascular disruptive agent (VDA) for treating both atrophic (dry) and neovascular (wet) forms of AMD.
CTZ1 is a unique vascular disruptive agent for combating the oxidative stress encountered in macular degeneration. CTZ1 combines an antioxidant carbazole moiety fused to a nicotine analog; consequently, this multi-pharmacophore combination mitigates oxidant stress experienced in AMD and can both stabilize and temper pathological angiogenic processes secondary to progressive AMD.
CTZ1 is currently being developed with potential as a topical (i.e., eye drop)and local (i.e., intravitreal) therapy.
Thomas Ciulla, MD, MBA, Chief Medical Officer & Chief Development Officer - Clearside Biomedical
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.
Georgea Pasedis, SVP, Global Medical Affairs - Dompé
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.
Armen Karamanian, MD, PhD, CEO - Eliksa Therapeutics
Eliksa Therapeutics is a venture-backed biotechnology company with a proprietary cGMP production facility and a robust clinical pipeline addressing unmet medical needs in ocular, cardiovascular and other difficult to treat indications. Our lead candidate, ELK-003, is a novel multi-target biological modulating inflammation, cell recovery, and tissue healing. ELK-003 has proven to be safe and well-tolerated with 18,000+ human doses without any reported side effects. ELK-003 is being tested in 5 investigator-sponsored trials at the University of Utah, including 2 ophthalmic indications.
Eliksa was founded in 2021 as a spin out of the University of Utah by a team of experienced biotech entrepreneurs with proven success in approving complex therapeutics, fundraising and successful exits.
The following is the University of Utah’s press release about the launch of Eliksa Therapeutics:
Henrik Nagel, CEO - EYE-GO A/S
EYE-GO A/S is a Danish MedTech start-up established 2015 based on the work by two designers wanting to develop eye-care technologies that improve the quality of life of people around the world suffering from severe and chronic eye conditions.
Problem: Only a fraction of patients achieves the full health outcome of treatment due to imperfections with current eye drop bottles. Users experience difficulties instilling the medication, over-dose due to drop size, side-effects and may abandon prescribed treatment plan leading to poor disease management.
Solution: MistGo® is a new generation proprietary micro-dosing drug delivery system (compatible
with Preservative Free drugs) mitigating the imperfections with current eye-drop bottles.
MistGo® makes it simple and comfortable to self-administer the drug correctly with the precisely required amount of drug entering the eye at first go, and helps patients adhere to treatment long-term.
Erick Co, PhD, CEO - Formosa Pharmaceuticals
Formosa Pharmaceuticals is a Taiwan-based biotech with primary focus in the areas of ophthalmology and oncology, and global alliances in US and Asia.
Formosa Pharmaceuticals' proprietary nanoparticle formulation technology (APNT) improves the dissolution and bioavailability of poorly-soluble APIs via a novel particle size reduction technique. APP13007, derived through APNT, has completed Phase 3 studies in the United States for the treatment of inflammation and pain after cataract surgery, and is preparing for NDA submission in 2023. APP13007 has been licensed in 2021 to China Grand Pharmaceutical and Healthcare Holdings, Ltd. for the Mainland China area. We welcome additional regional licensing partners for APP13007, as well as co-development opportunities utilizing APNT on small-molecule APIs which suffer from poor pharmacokinetics and bioavailability.
Bob Katz, CEO & President - FowardVue Pharma
ForwardVue Pharma is a pre-clinical ophthalmology company repurposing a well-characterized cancer compound into ocular formulations for treatment of neovascular retinal disease. With its potent and broad mechanism of action, clinical indications include wet Age-related Macular Degeneration (wAMD), Diabetic Retinopathy (DR). The neuroprotective properties of this compound may also be leveraged, leading to expanded indications including dry AMD.
Art Driscoll, Chief Development Officer - GelMEDIX
GelMEDIX is an early-stage company, innovating the next generation of ocular & regenerative therapies through a proprietary hydrogel platform which can deliver a broad array of therapeutics that is particularly well suited for vision restoring cell therapy. GelMEDIX is developing therapies to treat retinal disease, focusing on RPE (retinal pigment epithelium) cell therapy to treat age-related macular degeneration (AMD)/geographic atrophy (GA) via an in-situ crosslinking hydrogel formulation. The GelMEDIX formulation overcomes the challenges associated with existing approaches by allowing a less invasive liquid subretinal injection followed by crosslinking with visible white light, protection from injection-related shear stresses, cell localization at the target site, minimized cell aggregation, and improved monolayer formation. GelMEDIX is conducting in-vivo proof-of-concept studies to support early 2023 Series A fundraising with a goal to achieve an IND submission and prepare for clinical study. GelMEDIX also has a partnership with the US Army to develop an ocular sealant and is open to other partnerships to further expand its bioadhesive drug eluting hydrogel.
Tomas Navratil, Chief Development Officer - Glaukos
Founded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
We were the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure that revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device—the iStent®—in the United States, followed by our next-generation iStent inject® device in September 2018 and iStent inject® W in September 2020.
In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for
glaucoma, corneal health, and retinal diseases.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is located in Aliso Viejo, California, and we have additional locations in 9 regions around the world.
Glaukos is committed to investing in the future of ophthalmology to transform standards of care and improve patient lives. Our dedicated commitment to continuous innovation has resulted in an unrivaled pipeline of novel therapies.
Michael Young, PhD, FARVO, Co-founder & Chairman of SAB - InGel Therapeutics
InGel Therapeutics is a preclinical-stage cell therapy company with the mission to bring back light to patients with degenerative retinal diseases. Born in of the lab of Professor Michael Young at Harvard Medical School, our technology leverages the rescue, repair and regenerative pathways from cell-cell and cell-matrix interaction targeting diseases such as Retinitis Pigmentosa, Age-related Macular Degeneration, and Glaucoma.
InGel unique technology: a stem cell-biomimetic delivery system which enhances the regenerative properties of cells both in vitro and in vivo answers the challenges of stem cell therapy in the eye. Our proprietary cells are isolated to produce and release neuroprotective factor and are encapsulated in our matrix which possesses a low-immunogenicity and can be finely tuned for encapsulation and targeted delivery in the eye. InGel innovations is enabled by merging distinct fields for regenerative medicine in the eye: chemistry, material science, stem cell biology and tissue engineering.
Our first program-IGT001 leverages the neuroprotective pathways to rescue vision loss in patients with Retinitis Pigmentosa. InGel is currently conducting in-vivo safety, efficacy, and durability studies to support early 2023 Seed fundraising with a goal to start the GMP manufacturing of IGT001.
Julie Clark, MD, MS, VP, Clinical Development - Iveric Bio
Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration.
For more information on the Company, please visit www.ivericbio.com
George Magrath, MD, CEO - 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.
Clark Tedford, PhD, President & CEO - LumiThera
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.
Christian Roesky, CEO - 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.
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.
Liron Rosenbaum, VP, Strategy - NovaSight
Established in 2016, NovaSight is a growing medical device company with a mission to prevent vision impairments among pediatric patients using eye tracking based technology in novel diagnostic, therapeutic, and preventive solutions, especially designed for the unique needs of children. NovaSight has two flagship products:
- The CureSight™ - an FDA cleared digital therapy for amblyopia that is designed to replace traditional patching
- The EyeSwift®PRO - a comprehensive vision diagnostics device which screens for multiple vision impairments
Andrew Moshfeghi, MD, MBA
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.
Riad Sherif, CEO - Oculis
Oculis is a global biopharmaceutical company purposefully driven to save sight
and improve eye care with breakthrough innovations.
Mina Sooch, Founder & CEO - Ocuphire Pharma
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.
David Esposito, CEO - ONL Therapeutics
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 in Phase 1b studies in Geographic Atrophy, Open Angle Glaucoma and Retinal Detachment.
Russ Trenary, CEO - Outlook Therapeutics
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.
Sameer Sabir, Executive Chairman - Pykus Therapeutics
Pykus Therapeutics Inc. is a clinical stage medical technology company developing biodegradable polymers to provide solutions for unmet needs in vitreoretinal surgery. Pykus was founded in 2016 and is led by a team of committed physicians, scientists, engineers, and entrepreneurs. Our lead product, PYK-1105, is a novel biodegradable hydrogel that is designed to facilitate retinal detachment repair while eliminating the severe burdens placed on patients during recovery: face-down positioning, limited vision for months, and no air travel. Pykus has completed its proof-of-concept pilot study and is preparing for the next stage of clinical investigation.
Peter Francis, MD, PhD, Chief Medical & Scientific Officer - Ray Therapeutics
Ray Therapeutics Inc (RayTx) is a late-stage preclinical Bay Area biotechnology company pioneering the first-to-market precision optogenetic therapy for vision restoration that is highly active in ambient lighting (and will not require light-enhancing goggles). Our studies have shown for the first time that our proprietary ChRown optogenetic protein can restore high levels of visual acuity, contrast sensitivity and visual field.
RayTx lead asset, RTx-015, is expected to address the huge unmet medical in people suffering from many forms of retinal blindness (independent of the underlying genetic cause), including those with advanced age-related macular degeneration. RayTx has partnered with a world-leading AAV gene therapy manufacturer is utilizing their proprietary commercial manufacturing process and analytics to maximally de-risk clinical development. RayTx anticipates clinical trials will begin by the end of 2023 in our initial indication, retinitis pigmentosa.
Michael O'Rourke, CEO - Re-Vana Therapeutics
Re-Vana Therapeutics is an ocular drug delivery and therapeutic company developing the world’s in clinic first sustained release large molecule biologics, treating serious eye diseases in the clinic (no surgery) within a multi billion $ market segment. Re-Vana has developed three platform technologies EyeLief, EyeLief SD and OcuLief to deliver biologics, that also can uniquely deliver small molecules thus expanding global treatment opportunities.
Re-Vana has developed unique photo crosslinked biodegradable technologies, EyeLief®, EyeLief SD™ and OcuLief® that can deliver biologics and small drugs for between 6 months to 2 years. EyeLief and EyeLief SD are photo crosslinked prior to being inserted into the eye. OcuLief is a unique gel that forms an implant once inserted into the vitreous and then photo crosslinked in situ.
Tom Reeves, President & CEO - Ripple Therapeutics
Ripple Therapeutics is a clinical stage company focused on improving ophthalmic therapeutics with controllable, sustained drug delivery. Our technology platform is based on a discovery that drugs can be engineered into controlled release pharmaceuticals without polymers or excipients. These proprietary prodrugs undergo surface erosion to give zero order release kinetics and are highly engineerable to tailor drug dose and duration to the specific indication. Ripple’s lead program – IBE-814 IVT – is an intravitreal Dexamethasone prodrug implant targeting diabetic macular edema (DME) and retinal vein occlusion (RVO) with a 6-9 month duration. A Phase II trial (RIPPLE-1) is underway in Australia, New Zealand and Hong Kong with 52 patients enrolled and encouraging early results. In addition to early clinical success, we also have commercial traction for IBE-814 IVT with a licensing deal for our lead program with Laboratoires Théa for North America and Europe. We also have a terms sheet signed to license IBE-814 in China and are actively pursuing other geographies. Our ophthalmology pipeline also includes an intracameral Latanoprost prodrug implant targeting open angle glaucoma and ocular hypertension with a 6-12 month duration and repeat dosing. We have promising pre-clinical PK, safety and PD data demonstrating IOP lowering for >6 months. We’re now working on the pre-clinical and CMC preparations towards a Phase 1/2 trial which we expect to start in 2024.
Eric Schlumpf, President & CEO - Stuart Therapeutics
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 include Dry Eye Disease, Glaucoma, and Dry Age-Related Macular Degeneration.
Kamran Hosseini, MD, PhD, President & CEO - Surface Ophthalmics
Surface Ophthalmics, Inc. is a pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular diseases. We are striving to solve key patient needs in eye care through leveraging deep expertise, a bold approach, an eye toward efficiency, and a clear, differentiated clinical advantages. Our current drug pipeline consists of three proprietary drug candidates, all utilizing Klarity®, a patented delivery vehicle. We are led by an experienced and proven management team and board of directors with over 80 years of ophthalmology related professional experience.
Patrick Johnson, President - Sydnexis
Founded in 2014, Sydnexis Inc. is a privately held, clinical stage biopharmaceutical company based in San Diego. Sydnexis is currently evaluating its patented eyedrop formulation, SYD-101, in a Phase 3 clinical trial to decrease myopia progression in children.
Daphne Haim-Langford, PhD, Founder & CEO - Tarsier Pharma
Tarsier® Pharma is a late clinical-stage company dedicated to the development and commercialization of a breakthrough therapeutic approach for better and safer treatment of autoimmune and inflammatory ocular diseases. The TRS Platform Technology is a bio-inspired immunomodulator designed to treat blinding inflammatory ocular diseases, and is currently being developed as both eye drops and intravitreal injections.
Ocular inflammations are a group of diseases affecting the front and back of the eye. Non-infectious anterior and posterior uveitis are the most known ocular inflammatory diseases. However, ocular inflammation is a critical underlying mechanism in the pathology of other inflammatory eye diseases, such as non-evaporative dry eye, diabetic macular edema (DME), and dry age-related macular degeneration (AMD). Hundreds of millions of people in all age groups are suffering from ocular inflammatory diseases worldwide, conditions that pose severe risks of vision loss and blindness.
With a leadership comprised of a global team of experienced, motivated, and dedicated professionals, and backed by investors who are focused on strategic investments in ophthalmology, we plan to leverage our new immunomodulatory approach to disrupt how ocular inflammatory diseases are being treated.
Aziz Mottiwala, Chief Commercial Officer - Tarsus Pharmaceuticals
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing the development and commercialization of therapeutic candidates to address highly prevalent diseases with limited treatment options across a range of therapeutic categories including eye care, dermatology, and infectious disease prevention. Tarsus is studying two investigational medicines in clinical trials. Its lead product candidate, TP-03, is a novel therapeutic which has demonstrated positive results in two pivotal trials for the treatment of Demodex blepharitis. This highly prevalent eyelid margin disease affects approximately 25 million eye care patients in the U.S., with no FDA-approved treatments currently available. TP-03 is also being developed for the treatment of Meibomian Gland Disease. Tarsus’ second candidate, TP-05, is an oral, non-vaccine therapeutic under investigation for the prevention of Lyme disease and is being studied in a Phase 1b clinical trial. Learn more at TarsusRx.com.
Marc Odrich, MD, Chief Medical Officer - TearSolutions
TearSolutions is an early-stage clinical pharmaceutical company based out of Charlottesville, VA focused on a novel and disruptive treatment for ocular surface disease. Its lead candidate is Lacripep which is a naturally occurring nineteen amino acid fragment of the tear protein, Lacritin. The discovery of Lacritin is attributable to Dr. Gordon Laurie, our Chief Scientific Officer, and the work of his lab in the Department of Cell Biology at the University of Virginia. The 119 amino acid protein named Lacritin by Dr. Laurie is the result of an unbiased screen of the proteome of the human tear film. Both Lacritin and its naturally occurring truncation variant, Lacripep, are responsible for restoration of tear film homeostasis. We are beginning a dose ranging Phase 2 study in the general dry eye population after a successful first-in-human trial (achieved statistically significant improvement in an approvable sign and symptom at two weeks) in primary Sjogren’s Syndrome dry eye patients. For more information, visit: www.tearsolutions.com.
Monty Montoya, CEO - TherOptix
Our mission is to revolutionize ophthalmic drug delivery using a proprietary novel drug-eluting
contact lens platform providing more effective, sustained, and safer therapies for patients. With strong IP developed at MIT/Mass Eye & Ear/Boston Children's Hospital, we are focused on post-surgical pharmaceutical needs in ophthalmology with two drug-eluting lenses currently in development: TetraLens and DexaLens.
David Eveleth, CEO & Co-Founder - Trefoil Therapeutics
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.
Adam Szaronos, CEO - Trukera Medical
TearLab, founded in 2009, was built upon the recognition of the importance of corneal health to eye care practices. In 2022, TearLab announced the corporate name change to Trukera Medical, for the company’s further expansion in corneal health. The company introduced tear osmolarity testing to eye care with its flagship device, the TearLab Osmolarity System, which has been used over 24 million times worldwide. What began with a focus on osmolarity testing is now a comprehensive corneal health company working to address additional unmet medical needs in eye care.
Wesley M. Jackson, President & Chief Science Officer - Valitor
Valitor is conquering limitations of established drug targets by leveraging its multivalent polymer (MVP) technology to maximize benefits for patients. Using the MVP platform, multiple copies of bioactive molecules can be combined with individual biopolymer chains to create novel macromolecular entities that are engineered to overcome a multitude of specific challenges for their target bioactive molecules and indications. The resulting MVP compounds are designed to overcome specific drug design challenges, including optimized pharmacokinetic/pharmacodynamic properties, tissue localization, therapeutic durability, and safety. Accordingly, the company’s lead program, a novel anti-VEGF antibody treatment for wet AMD, is positioned to overcome long-standing drug development challenges with the potential of enabling only a twice-yearly treatment. It is currently entering IND-enabling studies. Valitor has designed its MVP platform with interchangeable bioactive molecules and biopolymers, which enables accelerated development of additional product candidates. Thus, Valitor can leverage validated clinical mechanisms to generate new compounds optimized to treat additional indications in ophthalmology, thereby de-risking the company’s pipeline expansion.
Jerry St. Peter, CEO & Board Member - Xequel Bio
Xequel Bio, a clinical stage biopharmaceutical company whose technology was licensed from the Medical University of South Carolina, is transforming its proprietary aCT1 peptide technology platform to develop drugs that will revolutionize the way the body responds to injury.
Led by a proven leadership team, Xequel Bio is poised for its next chapter of success leveraging deep R&D expertise and building on a proprietary platform with robust commercial potential.