Private Company Showcase
Allegro Ophthalmics, LLC is establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of diabetic macular edema (DME). Allegro’s lead investigational drug, risuteganib (Luminate), has successfully met the endpoints for three Phase 2 studies and is now cleared for US phase 3 studies in DME. In the phase 2 studies, Luminate has demonstrated the ability to reduce the current burden of intravitreal injections with 12 week durability and to treat anti-VEGF non-responsive DME patients by simultaneously targeting all four oxidative stress pathways. By bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision.
Eyedaptic’s unique Software for retina-related vision loss, embedded in Augmented Reality glasses, simulate natural vision for suffers with AMD and central vision loss, to restore a complete field of vision to help sufferers lead fuller lives. Equipped with patent pending software the Company’s solution optimizes the sufferer’s functional peripheral vision to help restore the entire scene for the wearer. Unlike other visual aids that use only magnification, thereby reducing the user’s field of vision, our solution maximizes their field of view. The camera captures the surroundings, manipulates the pixels and re-displays the image where the user can see it. The adapted view for the wearer takes advantage of the part of the retina that still functions well so the user sees the entire scene.
Graybug Vision is a clinical stage pharmaceutical company developing novel products for the treatment of ocular diseases. The company’s proprietary injectable products are designed to enable less frequent administration to reduce the burden of treatment for patients and their physicians. The company’s lead clinical-stage injectable product, GB-102, has the potential for twice per year dosing to treat patients with neovascular wet age related macular degeneration (wet AMD). Graybug Vision has also developed a library of preclinical compounds to treat primary open angle glaucoma (glaucoma) including potential best-in-class glaucoma agents with the potential for up to 6 months after a single injection.
iRenix is a clinical-stage biotechnology company with a drug delivery platform that revolutionizes the intravitreal injection (IVT) process. Since 2006, IVT volume has grown > 100-fold; however, the IVT process has not advanced, creating a significant unmet need for both patients and physicians. Our proprietary RAPIDD platform incorporates ultra-rapid, focal anesthesia via cooling, enabling faster intravitreal delivery and avoiding lidocaine-based anesthesia complications. Our RAPIDD “pre-filled” technology allows for one-step IVT drug delivery by incorporating anesthesia followed by intravitreal injection using a motor-driven injector. As indications for IVT expand to include dry AMD and glaucoma, the need for innovative IVT delivery will become even more acute. By addressing this unmet need, iRenix and our strategic partners will be poised to lead a growing, $10B+ IVT market.
Ocugenix is a therapeutic company that is focused on developing a new class of protein therapeutics that reverse both the fibrosis and angiogenesis that are characteristic of wet age-related macular degeneration (wet AMD), diabetic retinopathy and other angiopathic diseases. The technology is based on over 15 years of NIH funded research into the molecular mechanism of wound healing. At the end of wound healing, a molecular pathway is activated which induces a natural anti-angiogenic and anti-fibrotic process. Our compounds activate this natural mechanism to cause regression of the fibrotic and angiogenic network in the eye offering patients the best chance to restore their eyesight. The compound has been shown to have excellent results in animal models as well as a favorable safety profile.
ONL Therapeutics (ONL) is an emerging ocular therapeutics company committed to protecting and improving the vision of patients with diseases of both the inner and outer retina. ONL is pioneering an entirely new and broadly applicable approach to preserving sight. With relevance to a wide range of diseases including retinal detachment, glaucoma, diabetic retinopathy, and both wet and dry AMD, ONL is first and only company focused on preventing the death of retinal cells caused by Fas (CD95) activation and the initiation of multiple death and inflammatory signaling pathways resulting to cell death and vision loss. ONL1204, ONL's lead candidate with an FDA orphan designation for retinal detachment, is completing IND-enabling studies and with an IND to be submitted in 2018.
RFE Pharma Corp. is developing novel small molecule therapies for Age Related Macular Degeneration (AMD) and/or Diabetic Retinopathy (DR). The Company’s lead product is RFE-007-CAI, which has been acquired from the National Cancer Institute (NCI). Systemically administered CAI did not cause significant toxicity in over 900 patients. RFE Pharma has repositioned and reformulated this drug as an intravitreal ocular injectable therapy, and is targeting the IND filing of RFE-007-CAI proprietary intravitreal injectable formulations. Both a nanoparticle and cyclodextrin formulation are non-toxic and anti-angiogenic in multiple animal models of ocular neovascularization. CAI has also been incorporated into a PLGA matrix. RFE has secured $1.25MM of private equity financing from GenPharma, a private investor network, for its first round of financing the IND.
ZeaVision®, the parent company of EyePromise®, was founded in 2001, with a mission to fight vision loss and preserve healthy vision. With more than 20 years of research, our co-founder, Dennis Gierhart, Ph.D., pioneered the use of Zeaxanthin for eye health use.
Public Company Showcase
Aerie Pharmaceuticals, Inc. is a publicly traded pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of glaucoma and other eye diseases. Its lead product includes Rhopressa, a once-daily eye drop for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Rhopressa has been approved by the FDA and Aerie expects to launch the product by mid-second quarter 2018. The company is also developing Roclatan, a once-daily eye drop to reduce IOP that is in Phase III registration trials to treat patients with open-angle glaucoma and ocular hypertension. Aerie Pharmaceuticals, Inc. has a collaborative research and development agreement with Royal DSM NV. Aerie Pharmaceuticals, Inc. was founded in 2005 and is based in Irvine, California.
Clearside Biomedical, Inc., is a publicly-traded, late-stage clinical biopharmaceutical company developing innovative first-in-class drug therapies to treat blinding diseases of the eye using Clearside’s proprietary SCS™ microinjector to reach diseased tissue through the suprachoroidal space. Clearside’s portfolio of clinical/pre-clinical programs for back-of-the-eye diseases include RVO, uveitis, wet AMD and DME.
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.
GenSight Biologics is a clinical-stage biopharma company focused on developing gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight pipeline leverages two core technology platforms, Mitochondrial Targeting Sequence (MTS) and optogenetics to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight lead product candidate, GS010, is in PhaseIII trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease leading to irreversible blindness in teens and young adults. GenSight product candidates are designed to be administered in single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.
At Spark Therapeutics, a fully integrated company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia and neurodegenerative diseases. We have successfully applied our technology in the first FDA-approved gene therapy in the U.S. for a genetic disease, and currently have three programs in clinical trials, including product candidates that have shown promising early results in patients with hemophilia. At Spark, we see the path to a world where no life is limited by genetic disease.