OIS Retina @ ASRS | October 7, 2021 | San Antonio, TX
Bausch + Lomb
Bausch + Lomb is dedicated to protecting and enhancing the gift of sight. Bausch + Lomb is a global hallmark for innovation and quality, offering the widest and finest range of eye health products including ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments.
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.
Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. Through Surgical, Pharmaceutical and Vision Care, Alcon offers the world’s widest spectrum of ophthalmic products, helping millions of patients see the world better with clarity, color and beauty.
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.
Allergan (NYSE: AGN) is a unique, global pharmaceutical company focused on developing, manufacturing and commercializing high quality generic and innovative branded pharmaceutical products for patients around the world. The Company has approximately 30,000 employees worldwide and maintains global headquarters in Dublin, Ireland.
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.
Novartis is a leading ophthalmology company, with therapies that treat both front and back of the eye disorders, including retina diseases, glaucoma, dry eye and other external eye diseases. In 2016, approximately 200 million patients worldwide were treated with Novartis ophthalmic products.
Promedica International is a privately held, full-service, ISO-certified CRO providing clinical trial services for the medical device, biotechnology and pharmaceutical industries. Founded in 1985, Promedica International, a woman-owned corporation, is headquartered in Orange County, California. We have successfully been providing exceptional value to our clients for over 30 years in clinical trial project management, site recruitment and management, clinical study monitoring, data management, biostatistics, medical writing and GCP auditing.
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.
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.
Adverum is a clinical-stage gene therapy company targeting unmet medical need in ocular and rare diseases. We develop gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Our core capabilities include clinical development, novel vector discovery, and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices (cGMP) quality control. Our team has extensive clinical development experience and is laser-focused on advancing novel gene therapies for patients.
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.
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.
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.
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.
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.
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.
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. Visit www.lumithera.com to learn more.
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.
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.
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