Casey C. Kopczynski, PhD, Chief Scientific Officer - Aerie Pharmaceuticals
Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for open-angle glaucoma, ocular surface diseases and retinal diseases. In the U.S., Aerie markets Rhopressa® (netarsudil ophthalmic solution) 0.02%, a Rho kinase (ROCK) inhibitor, and Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. Aerie is expanding globally, with offices in Europe and Japan, and a manufacturing facility in Ireland. Rhokiinsa® (netarsudil ophthalmic solution) 0.02% and Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% are approved in the EU. A Phase 3 study of netarsudil ophthalmic solution is underway in Japan, in collaboration with Santen. Aerie is also pursuing additional candidates in ophthalmology, including a Phase 2b dry eye program with AR-15512 (TRPM8 agonist), and two clinical-stage retina programs, AR-1105 (dexamethasone) Sustained Release Implant and AR-13503 (Rho kinase/Protein kinase C inhibitor) Sustained Release Implant. Aerie continues to investigate assets from its proprietary library of small-molecule multi-kinase inhibitors.
Douglas Love, President & CEO - Annexon Biosciences
Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel complement medicines for patients with classical complement-mediated disorders of the body, brain and eye. The company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Specifically in geographic atrophy, C1q is deposited in all layers of retina, including on drusen, driving chronic, aberrant activation of the classical complement pathway. Our upstream complement approach targeting C1q blocks the entire classical complement pathway, including all inflammatory mediators, while the alternative and lectin complement pathways intact. This selective approach to fully inhibiting the classical complement pathway may provide enhanced efficacy and safety for patients suffering from geographic atrophy.
David Acheson, SVP, North America- Apellis
David Acheson is an accomplished senior commercial executive with over 20 years of commercialization success in both established and start-up organizations. David currently serves as the SVP, North America for Apellis Pharmaceuticals, a fast growing biotech leader committed to developing transformative therapies for people living with a broad range of debilitating diseases by controlling complement, specifically targeting C3 in the complement cascade. Since November 2019, David has been responsible for leading both the Rare Disease franchise as well as the Ophthalmology Business. David joined Apellis Pharmaceuticals from Circassia Pharmaceuticals, an Oxford UK based pharmaceutical and device diagnostics company, where he served as the SVP & General Manager for the U.S. region within the global organization, providing leadership in a start-up company that grew from $15 million in revenues to over $250 million in revenues within four years in the U.S., through both organic growth, partnerships and eventually an in-licensing deal with a large pharma organization.
Prior to his senior level leadership roles, David worked in multiple levels of responsibility in both well-established pharma organizations as well as several small pharma and start-up companies, working in roles of National Sales Director, VP Sales & Market Access, hospital and specialty Account Management, and has significant strategic experience in Patient Access, Reimbursement, Channel strategy and Distribution.
David holds a BS in Business from the University of Nebraska – Lincoln, and is based in the Apellis Pharmaceuticals headquarters located in Waltham, MA.
Ron Schneider, CEO & Co-Founder - Beyeonics
Beyeonics Surgical is a medical technology company developing surgeon-centered visualization solutions. Beyeonics brings the pilots Augmented Reality experience into the world of surgery – leverages cutting-edge fighter pilots head mounted display technologies to provide surgeons with outstanding visualization, exceptional comfort, streamlined information access and optimized surgical workflow.
Thomas Ciulla, MD, Chief Medical Officer - Clearside Biomedical
Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector® targets the suprachoroidal space (SCS®) and offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications. For more information, please visit www.clearsidebio.com.
Arthur Suckow, PhD, Co-Founder & CEO - DTx Pharma
At DTx, we are creating novel RNA-based therapeutics to treat the genetic drivers of disease. Our proprietary FALCON delivery technology platform utilizes fatty acids as targeting ligands to enable the delivery of oligonucleotide therapies to tissues and cell types throughout the body. In preclinical studies, we have demonstrated cellular uptake and broad activity of oligonucleotides in the retina, muscle, heart, neurons, T cells and many other specialized cell types.
Kaushal Solanki, PhD, UCSB, Founder & CEO - Eyenuk
Eyenuk, Inc. is a global artificial intelligence (AI) medical technology and services company and the leader in real-world AI Eye Screening for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk, and Alzheimer’s disease. The company’s EyeArt® AI System provides automated diabetic retinopathy (DR) screening, including retinal imaging, DR detection based on international clinical standards and immediate reporting, in a single office visit during a diabetic patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the DR detection results are available in a PDF report in less than 30 seconds.
Nancy Lurker, President & CEO - EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (formerly pSivida Corp.) is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company has developed 3 FDA-approved sustained-release treatments in ophthalmology. In addition, DEXYCU (dexamethasone intraocular suspension) 9% was approved by U.S. Food and Drug Administration (FDA) on February 9, 2018.
Patricia Zilliox, PhD, President & CEO - Eyevensys
Eyevensys is a France-based, VC-backed biotech company, also incorporated in USA. Eyevensys is developing a novel non-viral gene therapy for treatment of ocular diseases. The technology is comprised of a proprietary device that delivers plasmid DNA to the ciliary muscle. After electro-transfection, the muscle cells sustainably produce the therapeutic proteins that the plasmid encodes.
The company has successfully completed part 1 of it's clinical safety study in France and the UK, enrolling 9 patients with late stage non-infectious uveitis. Study is being expanded in less severe patients - An IND is being filed in USA in order to validate technology in a Phase 2 Clinical study -non-infectious uveitis .
Parallel programs are pursued with different proteins-one for treatment of retinitis pigmentosa, one for Wet AMD.
Samuel Barone, MD, Chief Medical Officer - Gemini Therapeutics
Gemini Therapeutics is a precision medicine company focused on the development of new therapies through a deeper understanding of disease. We are sharply focused on dry AMD which is a disease comprised of numerous genetic variants. We also believe that more precisely targeted therapeutics could better address the cause of a patient’s disease.
Daniela Ferrara, MD, MSc, PhD, Senior Medical Director - Genentech/Roche
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.
Magali Taiel, MD, Chief Medical Officer - GenSight Biologics S.A.
GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), has been submitted for marketing approval in Europe for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting primarily teens and young adults that leads to irreversible blindness. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.
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.
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.
Clark E. Tedford, PhD, Co-Founder, President & CEO - LumiThera
LumiThera is committed to creating brighter horizons for patients by developing treatment solutions utilizing Photobiomodulation to improve visual function, to stop or slow the progression of debilitating eye diseases, and to prevent vision loss and blindness.
LumiThera’s first product, Valeda Light Delivery System®, is the first approved treatment for Dry Age-Related Macular Degeneration using Photobiomodulation. Valeda improves visual acuity, improves contrast sensitivity, reduces central drusen volume, and is designed for ease-of-use in the clinician’s office.
Valeda is CE Marked in Europe and is in clinical trials and not approved for use in the United States.
Samarendra Mohanty , PhD, Co-Founder, President & Chief Scientific Officer - Nanoscope Therapeutics, Inc.
Kester Nahen, PhD, CEO - Notal Vision
Notal Vision is a patient-centric ophthalmic diagnostic services company to extend age-related macular degeneration (AMD) monitoring from the clinic to the home, providing Eye Care Professionals with remote diagnostic tools to support their patient care. With a proven approach to home-based, self-operated diagnostics, AI-enabled data analysis, and patient engagement, we are helping to improve visual outcomes by preserving patients’ vision. Notal Vision offers a full-service diagnostic clinic that provides holistic, beginning-to-end physician and patient education, engagement and support. Directed by practicing ophthalmologists and supported by a team of certified ophthalmic professionals and patient engagement specialists, the Notal Vision Diagnostic Clinic is medical provider and the epicenter for patient and physician engagement. The ForeseeHome AMD monitoring program informs referring physicians of early signs of conversion from intermediate dry to wet AMD. The Home OCT pipeline platform will support personalized treatment of patients with exudative retinal diseases by monitoring fluid volumes remotely.
Mina Sooch, CEO & Co-Founder - Ocuphire PHARMA
Ocuphire is a clinical-stage ophthalmic company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates, Nyxol and APX3330, targeting front and back of the eye indications respectively. APX3330 is a twice-a-day oral tablet designed to target multiple pathways relevant to retinal diseases including diabetic retinopathy (DR) and diabetic macular edema (DME). APX3330 had been studied in six Phase 1 and five Phase 2 trials totaling over 340 patients for inflammatory and oncology indications, and demonstrated promising evidence of tolerability, pharmacokinetics, durability, and target engagement. Ocuphire is currently enrolling patients in Phase 2 trial for APX3330 for treatment of patients with DR, including moderately severe non-proliferative DR and mild proliferative DR, as well as patients with DME without loss of central vision. Future trials will explore APX3330 for retinal indications including wet age-related macular degeneration, and geographic atrophy.
C. Russell Trenary III, President & CEO - Outlook Therapeutics
Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010/LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating a range of retinal diseases in the United States, United Kingdom, Europe, Japan, China and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway, initially for wet AMD. For more information, please visit www.outlooktherapeutics.com.
Friedrich Asmus, MD, Chief Medical Officer - Oxular
Oxular is a leading, clinical-stage retinal therapeutics company that is developing technology to transform the treatment of retinal disease, offering patients life-changing solutions to their unmet needs. Oxular's sustained-release drug formulations (OxuspheresTM) are engineered to last up to one year following single administration and perform in specific small spaces in the eye. This approach provides unique and precise drug distribution to tissues specifically involved in retinal diseases. Oxular's drug administration technology (Oxumlumis®) is engineered to access these critical tissues through minimally invasive supreachoroidal space delivery. This novel combination aims to substantially improve patient quality of life by increasing therapeutic effectiveness and patient safety, while reducing side-effects and minimizing the frequency of treatments.
Oxular’s lead asset, OXU-001, a 12-month treatment for diabetic macular edema (DME), is currently in preparations to begin human clinical trials. Oxular’s other development program includes treatments for macular degeneration, ocular cancers and delivery of gene therapies.
Lloyd Diamond, President & CEO - Pixium Vision
OUR VISION: To create a world of bionic vision for those who have lost their sight.
OUR MISSION: To provide best in class bionic vision restoration systems enabling the blind to regain greater autonomy and improved quality of daily living. Pixium Vision, created in December 2011, is a bioelectronics and brain machine interface technology company specialized in neuromodulation application whose mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Prima System features a miniaturized and totally wireless sub-retinal PRIMA implant, a pocket computer equipped with breakthrough algorithms, and a pair of glasses which captures the visual scene. For the novel breakthrough Prima system, the exclusive transfer of the patented technology was granted by Stanford’s University to Pixium Vision to develop and industrialize the PRIMA bionic vision system.
Suber Huang, MD - Regenerative Patch Technologies
Regenerative Patch Technologies, LLC (RPT) is a California company developing cell-based implant technology for the treatment of retinal diseases.
RPT was founded by Drs. Mark Humayun and David R. Hinton from the University of Southern California and Dr. Dennis O. Clegg from UC Santa Barbara.
The technology to produce the CPCB-RPE1 implant is exclusively licensed to RPT from the University of Southern California, the California Institute of Technology and UC at Santa Barbara.
David Scisciani, Director Strategic Accounts - 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.
Stephen Pakola, MD, Chief Medical Officer - 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 to address genetic defects in cells, enabling the production of therapeutic proteins or antibodies that are intended to impact disease. Through a single administration, gene therapy could potentially alter the course of disease significantly and deliver improved patient outcomes with long-lasting effects. We have developed a broad pipeline of gene therapy programs using our NAV® Technology Platform to address genetic diseases through two modalities: AAV-mediated antibody delivery and monogenic gene replacement. 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.
Michael O'Rourke, CEO - Re-Vana Therapeutics
Re-Vana is a pharmaceutical company, founded in Belfast, Northern Ireland U.K in 2016 as a spin out from Queen’s University. Our primary focus is to develop the world’s first in clinic sustained release biologic treating retina diseases Strategy is the internal development of a sustained release biologic and securing collaborations for novel therapeutic development In the past 12 months we have accomplished: - Advanced Proof of Concept - In-vivo animal studies demonstrated 6 month tolerability, safety, efficacy of an anti VEGF drug - Series A planned to support internal development for at least a 6 month sustained release therapeutic - Successfully achieved milestones under collaboration with a Global Pharma Co. - $3.25M pre-Series A Round closed in 2020 with ophthalmic focused VC's - ExSight Ventures, Visionary Ventures and InFocus Ventures - First time all 3 VC's invested into the same company - Strengthened world class internal and scientific advisory teams
Rajat N Agrawal, MD, MS - VP, Clinical Development & Ophthalmology Lead
Rezolute is developing transformative therapies for metabolic diseases related to chronic glucose imbalance. The Company’s lead clinical asset, RZ358, is in Phase 2b development for treatment of congenital hyperinsulinism (CHI), a rare pediatric endocrine disorder. The Company is also developing RZ402, an orally available plasma kallikrein inhibitor, for the treatment of diabetic macular edema, currently in Phase-1 development.
Thomas Ruggia, President & CEO - Samsara Vision
Samsara Vision is a privately held specialty medical device company engaged in the research, development, manufacture, and marketing of proprietary implantable ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders. We believe that rejuvenating eyesight revives the spirit, allowing people to reconnect to the things in life that they love to see and do. Our approach includes working collaboratively with health care providers, researchers, payers, and advocates to ensure that people living with deteriorating vision have access to our novel technologies and support paths thereby better ensuring a future where they can see anew.
Anirvan Ghosh - CEO - UNITY Biotechnology
UNITY is developing a new class of therapeutics to slow, halt or reverse diseases of aging. Pursuing multiple approaches that target novel biology, UNITY’s current focus is on creating medicines to selectively eliminate or modulate senescent cells – cells that secrete large quantities of harmful proteins that cause inflammation, dysfunction, and tissue degradation, along with growth factors that alter the tissue microenvironment – and thereby provide transformative benefit in age-related ophthalmologic and neurologic diseases. UBX1325, a potent Bcl-xL inhibitor that targets proteins which senescent cells rely on for survival, is currently being evaluated for the treatment of diabetic macular edema (DME), diabetic retinopathy and age-related macular degeneration (AMD) for patients who have little to no response to anti-VEGF. Initial data from a Phase 1 safety study in patients with DME and wet AMD demonstrated that UBX1325 was well-tolerated with no treatment-related adverse events or dose-limiting toxicities, supporting initiation of a Phase 2a proof-of-concept study in DME. Additionally, the Phase 1 study showed initial efficacy, including rapid improvements in best-corrected visual acuity (BCVA), central subfield thickness (CST), and sub- and intra-retinal fluid (SRF, IRF) – all key clinical measures of disease progression, observed in a majority of trial subjects. UNITY is also developing a novel antibody with a unique mechanism of action distinct to anti-VEGF therapies, UBX2050, that activates the Tie2 pathway to restore healthy vasculature and function in age-related eye diseases.