Jim Taylor, CEO - 2C Tech
2C Tech intends to validate and develop the potential of Nanoparticle technologies to provide effective and meaningful therapeutic benefits to patients with retinal degenerative conditions. Our immediate focus is on the use of Quantum Dots (QDs) as a therapeutic option for patients with Retinitis Pigmentosa.
Per Gjorstrup, MD, PhD, CEO & President - Anida Pharma
Anida is a late stage preclinical company with a first IND planned for 2022. Our lead molecule, AP-001 is a first-in-class multi-targeting endogenous compound with a beneficial activity profile confirmed in a wide range of in vivo models covering both anterior and posterior segment indications, and further supported by safety data. Due to its unique physiochemical properties with an excellent ocular tissue distribution profile AP-001 is intended for topical delivery to treat retinal conditions including AMD and DME/DR, and ROP. AP-001 is also being developed for conditions with loss of corneal integrity.
Anders Haegerstrand, MD, PhD, CEO - Annexin Pharmaceuticals
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.
Michael Overdorf, Executive Vice President and Chief Business Officer - Annexon Biosciences
Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company that aims to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late- stage clinical trials, with clinical data anticipated throughout 2022 and 2023.
Federico Grossi, MD, PhD - Apellis
At Apellis, we are committed to developing transformative therapies for people living with a broad range of debilitating diseases by controlling complement, part of the body’s immune system.
Jorge Calzada, MD - BVI
Dr. Calzada is sharing his experience with the Beyeonics One™. The first ophthalmic exoscope with augmented reality surgical headset.
Meticulously developed for ophthalmic surgeons - Beyeonics One™ is designed to deliver unconstrained visualization and on-demand, consolidated, pre-operative data, which are naturally accessible and controlled by an immersive Augmented Reality Surgical Headset.
Beyeonics One™ is developed and manufactured by Beyeonics Vision which is proud to partner with BVI in bringing Beyeonics One™ to practices across the US market.
BVI Medical is refocusing the future of vision by adopting a surgeon-centric approach of listening to our customers and innovating around their needs. Beyeonics One™ elevates BVI’s purpose-built portfolio of comprehensive surgical solutions for cataract and retina, as well as refractive, glaucoma, and dry eye to deliver best-in-class partnership and service to our customers.
Thomas A. Ciulla, MD, MBA, Chief Medical Officer and 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.
Matthias Steger, PhD, MBA, Co-founder & CEO - Endogena Therapeutics
Endogena Therapeutics is a clinical-stage biotech company that discovers and develops first-in-class endogenous regenerative medicines to repair and regenerate tissues and organs. Our approach has the potential of a paradigm shift to treat degenerative conditions related to ageing and genetic disorders.
Endogena is focusing its drug discovery and development efforts on indications with high unmet medical needs. Recent discoveries in stem cell biology together with technological advances for phenotypic, functional screening, have unlocked our ability to harness the potential of adult stem- and progenitor cells. Our novel drug discovery approach is based on the concept of selective regulation of these endogenous cells for controlled tissue repair by small molecules.
Endogena’s lead program for retinitis pigmentosa is in clinical phase. We are working with leading vitreoretinal specialists across the US and Europe to bring a novel treatment paradigm to retinitis pigmentosa patients who are losing their vision with no broadly applicable treatment available.
Nancy Lurker, President & CEO - EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc., is a pharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious eye disorders.
Patricia Zilliox, PhD, CEO & President - Eyevensys
Eyevensys is a Clinical stage company developing an innovative non-viral gene therapy platform targeting eye indications.
Eyevensys has developed a proprietary electro-transfection delivery system which can administer proprietary plasmids able to deliver sustained proteins to the back of the eye. The technology involves a minimally invasive procedure which will lead to better safety, compliance and clinical outcome.
The primary targeted indication of interest is Wet AMD.
The second targeted indication is geographic atrophy, the late stage of Dry AMD with an upside in Retinitis pigmentosa and glaucoma.
The technology developed has been evaluated and validated for its feasibility and safety in a safety phase 1 clinical trial, in 18 patients with late stage non-infectious uveitis.
Eyevensys has a strong management team with extensive clinical ophthalmology drug development expertise and gene therapy from Big Pharma.
Eyevensys has also partnered with two key manufactures for the platform, in USA, Phillips Medisize and Minnetronnix medical.
The company is ready to launch its series C and also looking for co-development /partnerships opportunities.
Frederic Guerard, CEO - Graybug Vision
Every day, Graybug Vision works relentlessly to make healthy vision more accessible and more manageable for patients with chronic vision-threatening eye diseases. We are a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of chronic diseases of the retina and optic nerve. Our novel proprietary technologies are designed to release drugs in ocular tissue at a controlled rate for up to 12 months in order to improve patient compliance, reduce healthcare burdens and, ultimately, deliver better clinical outcomes.
Sangyeul Han, CEO - Ingenia Therapeutics
INGENIA Therapeutics has developed a portfolio of novel biotherapeutic candidates to halt and reverse chronic disease progression by restoring dysfunctional vasculature to its healthy state. INGENIA’s lead candidate, IGT-427, has dual function, blocking VEGF signaling and activating Tie-2 signaling more strongly and durably than Ang-2 blockade. In addition, pegylated IGT-427 variants show a longer vitreal half-life than standard of care. In combination with its superior target engagement property, a long-lasting IGT-�427 variant can be a more effective and durable option in multiple retinal disease markets.
Pravin Dugel, MD, President - Iveric Bio
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.
Theresa Heah MD MBA, President and Chief Medical Officer, Kriya Ophthalmology - Kriya Therapeutics
Kriya is a fully integrated gene therapy company on a mission to revolutionize how gene therapies are designed, developed, and manufactured – with a goal of improving speed to market and reducing cost. The company leverages its proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer products with the potential to transform the treatment of a broad range of diseases. Kriya’s team includes scientific pioneers with decades of experience in product development, complex manufacturing, and computational engineering. The company has established an ecosystem for delivering best-in-class technologies and medicines, with core business units in technology, manufacturing, R&D, and therapeutics. Kriya’s product pipeline addresses diseases of high unmet need with therapeutic area divisions in ophthalmology, oncology, rare disease, and chronic disease, each led by industry veterans with a track record of advancing products from concept through commercialization. Built upon this foundation, Kriya achieves the scale needed to drive transformational improvements in the engineering, production, and translation of gene therapies. For more information, please visit www.kriyatx.com.
Levent Akduman, MD, FASRS , CEO - Staphyloma Support Device
LA Eye, LLC has the patented product, Staphyloma Support Device (SSD), also known as Titanium Macular Buckle, in development for application in various stages of pathologic myopia. SSD is designed to address the anatomic root cause of the problem in pathologic myopia helping to reshape the contours of the posterior sclera to a more natural form and reduce the axial length so to treat or prevent blinding myopic maculopathy. An additional gain appears to be the reduction of the refractive error at least up to 18 diopters.
Samarendra Mohanty , PhD, Co-Founder, President & Chief Scientific Officer - Nanoscope Therapeutics
Nanoscope Therapeutics is a clinical-stage biopharmaceutical company advancing an optogenetics gene therapy platform for restoring vision in patients with retinal degenerations by reprogramming the surviving retinal cells to be photosensitive. The gene-agnostic optogenetics therapy focuses on disease phenotype instead of specific genotypic deficits and allows treatment of disease regardless of genetic mutations. Nanoscope has developed an ambient light-activatable Multi-Characteristic Opsin (MCO) that does not require an external light activation device, thus limiting potential photo-toxicity. The company’s proprietary MCO has unique characteristics including broadband light sensitivity with fast kinetics, allowing activation of retinal neurons in natural light environments. Nanoscope’s phase 1/2a study for patients blinded by advanced retinitis pigmentosa (RP) showed a positive safety and efficacy profile over 52 weeks. Nanoscope is currently enrolling in a multicenter, randomized placebo-controlled phase 2b clinical trial for RP in the U.S. The company also plans additional clinical trials in a broad range of inherited retinal disorders (IRDs), including Stargardt disease, Cone-rod dystrophy, Leber congenital amaurosis, Usher syndrome, and Choroideremia. Nanoscope's MCO platform technology has also shown potential to treat geographic atrophies (GA) in dry age-related macular degeneration (AMD) and end-stage wet AMD.
Robert B. Bhisitkul, MD, PhD, Professor Of Ophthalmology, University Of California San Francisco School Of Medicine
Oculinea Inc is a preclinical stage drug-device therapeutics company focused on developing transformational drug delivery implants for vision care. A unique and proprietary technology based on engineered biodegradable polymers has been developed at University of California San Francisco (UCSF) for sustained ocular delivery of both small molecules and biologics. The platform is backed by several preclinical studies that demonstrated zero-order drug release for up to 6 months or greater with 7 different drug classes. Oculinea’s product platform - Miniaturized Injectable Deliver System (MIDS) is designed for simple in-office procedures to enhance efficacy, provide optimum route of administration, and improve patient compliance leading to superior clinical and economic outcomes. Oculinea’s business is focused on (i) IND enabling studies of intravitreal implants for the glaucoma product platform, and (ii) developing biologic delivery intravitreal implants for retinal disorders through strategic collaborations with biopharma companies.
Mina Sooch, MBA, President & CEO - Ocuphire
Ocuphire Pharma is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders. APX3330, a novel, first-in-class, twice-daily oral tablet drug candidate, specifically targets Apurinic/Apyrimidinic Endonuclease 1/Redox Effector Factor-1 (APE1/Ref-1) protein, referred to as Ref-1. APX3330 has a dual mechanism of action in validated pathways, decreasing both abnormal angiogenesis and inflammation by blocking pathways downstream of Ref-1. APX3330 specifically blocks Ref-1’s redox signaling function leading to simultaneous decreases in the activity of several important proangiogenic and proinflammatory transcription factors relevant to the pathophysiology of retinal and choroidal vascular diseases: HIF-1a to reduce VEGF signaling and NF-kB to modulate VEGF, TNF-α and other inflammatory cytokines. APX3330 is currently being developed for diabetic retinopathy (DR) and diabetic macular edema (DME). These indications have approved intravitreal injection products that have established a precedent FDA approval pathway. APX3330 has been studied in over 440 subjects across 11 Phase 1 and Phase 2 non-ocular clinical trials, with few systemic adverse events reported and clinical data that support chronic administration. Based on APX3330’s clinical and pre-clinical data, Ocuphire plans to initiate a Phase 2 trial for APX3330 in the first quarter of 2021 for the treatment of moderately severe non-proliferative DR (NPDR) and mild proliferative DR (PDR), as well as patients with DME without loss of central vision. APX3330: 600mg Oral Dose APX3330 is an investigational drug candidate that is being tested in clinical trials and has not yet been approved by the FDA or other regulatory agencies for commercial sale.
Kerrie Brady, President & CEO - OcuTerra Therapeutics
OcuTerra Therapeutics, Inc. is developing innovative drugs for ophthalmic diseases for which the current standard of care does not prevent or control the progression of disease. Our initial therapeutic, OTT166, administered as an eye drop containing a novel integrin-inhibitor, is in Phase 2 clinical development to enable earlier, non-invasive, active treatment of non-proliferative diabetic retinopathy (NPDR), a chronic, progressive disease that is one of the leading causes of vision loss globally. Our goal is to bring transformative treatments to clinicians and their patients who are consigned to watch and wait as disease progresses, ultimately requiring medically intensive and invasive therapy.
David Esposito, President & 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.
Megan Baldwin, PhD, CEO & Managing Director - Opthea
Opthea Limited (NASDAQ: OPT; ASX: OPT) is a public biotechnology company developing OPT-302, a novel biologic inhibitor of VEGF-C and VEGF-D, for use in combination with VEGF-A inhibitors for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Opthea is currently conducting two concurrent Phase 3 clinical trials with OPT-302 which are actively recruiting and enrolling treatment-naïve patients for the treatment of wet AMD.
Ben Yerxa, PhD, CEO - Opus Genetics
Opus Genetics is a groundbreaking gene therapy company for inherited retinal diseases with a unique model and purpose. Backed by Foundation Fighting Blindness’s venture arm, the RD Fund, Opus combines unparalleled insight and commitment to patient need with wholly owned programs in numerous orphan retinal diseases. Its AAV-based gene therapy portfolio tackles some of the most neglected forms of inherited blindness while creating novel orphan manufacturing scale and efficiencies. Based in Research Triangle Park, N.C., the company leverages knowledge of the best science and the expertise of pioneers in ocular gene therapy to transparently drive transformative treatments to patients.
Russell Trenary, President & CEO - Outlook Therapeutics
Outlook Therapeutics is a 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. If ONS-5010 ophthalmic bevacizumab 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 and other markets. Outlook Therapeutics expects to submit ONS-5010 ophthalmic bevacizumab to the U.S. FDA as a BLA under the PHSA 351(a) regulatory pathway.
TBD - Regeneron
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
Sherri Van Everen, PharmD, Vice President, Clinical Development - Regenxbio
REGENXBIO Inc. is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Our gene therapy product candidates are designed to deliver functional genes, enabling the production of therapeutic proteins or antibodies that are intended to impact disease. Through a single administration, gene therapy has the potential to provide long-lasting effects and improved patient outcomes. We have developed a broad pipeline of gene therapy programs using our NAV® Technology Platform. We believe this platform forms a strong foundation for our current programs, and with our ongoing research and development, we expect to continue to expand the platform.
Carlos Ciller, CEO - RetinAI
RetinAI Medical AG (RetinAI) develops software solutions to accelerate and optimise clinics, research and pharmaceutical workflows, making eye health institutions more efficient with insights and knowledge extracted from data. The company builds software solutions to collect, organize and analyze health data from the clinic level, all the way to pharma, empowering communities of healthcare professionals & patients with data analysis.
RetinAI pioneers a software that, based on evidence and data, enables the right decisions sooner in healthcare and provides certified solutions to pharma, research and clinics alike. RetinAI Discovery® is a CE-Marked and FDA-cleared medical image and data platform, cloud-based, that digests and harmonise at-scale volumes of data. Thanks to proprietary AI models, Discovery enables precision analysis and transfer of medical data linked to the patient, connecting devices, data sources & decisions in a seamless and easy manner.
Discovery is the workbench for healthcare professionals throughout the entire journey of the disease, easing diagnosis and optimizing analysis for better care at every step.
Michael O'Rourke, CEO - Re-Vana Therapeutics
Re-Vana Therapeutics, a venture backed spin out from Queens University Belfast Nth Ireland founded in 2016, is an ocular drug delivery and therapeutic company developing the world’s first 6 months+ sustained release in clinic biologics, treating serious eye diseases in the clinic within a multi billion $ market segment. Re-Vana has developed three platform technologies EyeLief®, EyeLief-SD™ and OcuLief® to deliver biologics, that uniquely, can also deliver small molecules from the same platforms, thus expanding global treatment opportunities. In addition Re-Vana has the potential for strategic expansion into non ocular market segments. Our strategy includes both internal therapeutics development and building external strategic collaborations.
Michael S. Tsipursky, MD, CEO - ReVive Biotechnology
Revive Biotechnology, Inc. is a company focused on improving oxygen delivery to various hypoxic tissues. We have developed proprietary nanotechnology and have advanced through the proof of concept studies for ocular hypoxic conditions in an animal model. We are working through the regulatory process to achieve FDA approval for this ground breaking therapeutic for ischemic retinal conditions. Our beachhead market is CRAO (Central Retinal Artery Occlusion), which has no current efficacious treatment and fit orphan criterion. We will be developing our technology to treat larger allied retinal ischemia conditions such as vein occlusions and diabetic retinopathy. In the meantime we are adapting our technology and expanding IP to wound care, corneal diseases, traumatic brain injury, organ transplant and pulmonary fibrosis.
Rajat Agrawal, MD, Vice President, Clinical Development & Ophthalmology Lead - Rezolute
Rezolute is a clinical stage biopharmaceutical company dedicated to developing transformative therapies for patients suffering from debilitating metabolic diseases. We take novel approaches to defined disease pathways and leverage our metabolic expertise to develop therapies that have the potential to overcome the shortcoming of current standards of care by significantly improving clinical outcomes for patients.
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 30 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. Our ophthalmology pipeline also includes an intracameral Latanoprost prodrug implant targeting open angle glaucoma and ocular hypertension with a 6-12 month duration. We have promising pre-clinical PK/PD and safety data and have filed a PIND document with the FDA and expect to meet with them in June of 2022.
Thomas Ruggia, President & CEO - Samsara Vision
Samsara Vision is a company focused on bringing vision and freedom back to patients blinded by late-stage AMD. Our SING IMT is an implantable medical device that has demonstrated significant vision and quality of life improvements for patients who had few options. We are launching the SING IMT in Europe and select global markets. We are underway with our CONCERTO trial in the United States. This is a PMA-Supplement trial. Our IMT is already approved in the US.
Daniel Chung, MD, Chief Medical Officer - SparingVision
SparingVision is a genomic medicines company with a mission to translate pioneering science into vision saving treatments. Leveraging its unparalleled understanding of retinal diseases, SparingVision has built the world’s most compelling portfolio of synergistic cutting-edge gene therapy and genome editing treatments for inherited retinal diseases (IRDs). Both of its most advanced products, SPVN06 and SPVN20 look to go beyond single gene correction therapies to deliver new mutation agnostic treatments for Retinitis Pigmentosa (RP), a group of IRDs which are the leading cause of blindness globally. The Company also has a strategic collaboration with Intellia Therapeutics (NASDAQ:NTLA) to develop novel genome editing-based treatments for ocular diseases utilizing CRISPR-Cas9 technology.
Gordon Bethwaite, CEO - Vitranu
Vitranu is developing a Tunable Extended Release Capsule (TERC) for biologic pharmaceuticals and small molecules delivered via intravitreal injection, with a lead indication of wet Age-related Macular Degeneration.
The company uses novel electrospinning technology to produce a biodegradable, tunable capsule that can be filled with either biologic or small molecule therapeutics. By altering the electrospinning process parameters, capsules can be made with defined pore sizes and tuned to deliver the payload with the desired drug elution over time. This patented and unique approach provides a platform technology to fulfill the unmet need of sustained drug delivery.
Preclinical in vitro proof of concept data has shown a 9-month duration of effect for bevacizumab.