Apellis is a global biopharmaceutical company that leverages courageous science, creativity, and compassion to lead the development of therapies that target the complement system. Apellis is committed to addressing the unmet medical needs of patients and eye care professionals worldwide, with the goal of slowing progression of Geographic Atrophy.
Regeneron is a leading biotechnology company that invents life-transforming medicines for serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly translate science into medicine has led to numerous FDA-approved treatments and product candidates in development.
Coherus BioSciences, Inc. is committed to expanding patient access to cost-effective, lifesaving
medicines and delivering significant savings to the U.S. healthcare system. Founded a decade ago with a
focus on providing the highest quality biosimilar treatments, our team is deeply experienced in
analytical and process sciences, clinical development, and regulatory affairs, with proven commercial
capabilities. Building on our success with biosimilars, we are expanding our product portfolio to novel
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.
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.
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. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2 clinical testing. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations.
CTRG | Clinical Trials Resource Group
CTRG is experienced at all levels from site, to sponsor, to regulatory, and everything in between. We work collaboratively with you to identify obstacles before they are encountered, maximizing efficiency, and accelerating development timelines. CTRG has extensive experience with Phase 1 through 4 pharmaceutical as well as medical device studies. We are committed to the success of your clinical trial development program.
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.
InFocus Clinical Research
At InFocus Clinical Research we are dedicated to advancing the understanding and treatment of retinal diseases. As a leading Contract Research Organization (CRO) with a specialized focus in retina, we provide a range of clinical research services that help our partners accelerate the development of new therapies and technologies. Our team of experts has extensive experience in both clinical trial management and the field of retina research and is committed to providing tailored support services that meet the unique needs of each study. We work closely with our clients to develop customized solutions that optimize trial efficiency, minimize risk, and enhance data quality. Our approach is patient-centered and personalized, with a focus on improving outcomes for those affected by retinal diseases. By leveraging our extensive network of industry contacts and research sites, we help our clients stay at the forefront of the latest developments in retinal research. At InFocus Clinical Research, we are proud to be a trusted partner for our clients, and we are committed to delivering high-quality research solutions that drive innovation and improve the lives of those living with ophthalmic and retinal diseases.
Iveric Bio, An Astellas Company, 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.
jCyte is in late-stage development of a first-in-class allogeneic cell therapy for retinitis pigmentosa. The treatment is a minimally-invasive intravitreal injection than can be performed with topical anesthetic.
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.
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.
Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’ highly differentiated clinical-stage pipeline comprises multiple innovative product candidates in development for eye diseases of high unmet need. It includes OCS-01 eye drops, a topical candidate in Phase 3 development for diabetic macular edema (DME) and inflammation and pain following ocular surgery; OCS-02 eye drops, a topical biologic candidate in Phase 2 development for dry eye disease (DED) and uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders, such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The first in-patient, proof-of-concept trial with OCS-05 is currently ongoing in France. Headquartered in Switzerland and with operations in the US, Europe, and China, Oculis’ goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team with a successful track record in the pharmaceutical industry, supported by leading international healthcare investors.
Ocuphire Pharma is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders.
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.
Opthea (Nasdaq: OPT; ASX:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD). Opthea’s lead product candidate OPT-302, is a first-in-class VEGF-C/D ‘trap’ being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone. Opthea has completed a 366-patient Phase 2b clinical trial for the treatment of wet AMD in which OPT-302 administered in combination with the VEGF-A inhibitor Lucentis® (ranibizumab) demonstrated superiority in visual acuity gain compared to Lucentis® administered alone. Opthea is currently recruiting patients into two pivotal Phase 3 clinical trials, ShORe and COAST, with completion of patient recruitment expected as early as December 2023.
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.
Stealth BioTherapeutics is an innovative biopharmaceutical company developing therapies to treat mitochondrial dysfunction associated with genetic mitochondrial diseases and common diseases of aging. Our team works with patients and advocacy organizations to better understand their journey with mitochondrial disease and raise awareness of the unmet need our programs seek to address.