OCTOBER 25, 2018 | CHICAGO, IL
Aerpio Pharmaceuticals is a biopharmaceutical company focused on advancing first-in-class treatments for ocular diseases. Our lead product candidate, AKB-9778, is a small molecule Tie2 activator currently in a Phase 2b study (TIME-2b) for the treatment of non-proliferative diabetic retinopathy (NPDR). We are also developing a topical ocular formulation of AKB-9778 for development in primary open angle glaucoma.
AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases, with an initial focus in ophthalmology. AGTC’s product pipeline includes clinical-stage ophthalmology programs in XLRS, XLRP, achromatopsia, and a preclinical optogenetics program.
Allegro Ophthalmics is establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Currently in multiple Phase 2 studies, Allegro’s Luminate has the potential to provide new treatment options for patients with diabetic macular edema, non-proliferative diabetic retinopathy, neovascular age-related macular degeneration and vitreomacular traction.
ArcScan’s Swept Beam Liquid Interface TM technology delivers dramatic developments in ultrasound imaging not seen in decades. It provides OCT like images of the entire anterior segment from the cornea to the posterior of the lens with patient seat times of just a few minutes, measurement precision on par with optical imaging systems and with the added benefit of making those measurements behind the iris. This is not a handheld device and utilizes many of the components of modern optical imaging systems but using very high frequency ultrasound. Clinical benefits include precision imaging behind the iris for better ICL/IOL sizing, comprehensive anterior segment measurement tracking for early glaucoma management and MIGS evaluation, and wide angle cornea layer mapping for keratoconus screening and inlay evaluations.
At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed. Our first product candidate, AU-011, is a proprietary viral-like particle bioconjugate that is being developed for the treatment of choroidal melanoma. This cancer is the most common intraocular cancer in adults, is life threatening and there are currently no FDA approved therapies. Aura is developing the first targeted therapy that may enable early treatment intervention with vision preservation to dramatically change the outcomes for patients with this rare and life threatening disease.
Equinox Ophthalmic, Inc., is a venture backed medical device manufacturer focused on commercializing patient centric medical technologies for people with glaucoma. The company has developed a revolutionary technology that is a programmable, non-invasive, non-surgical, and non-pharmacological way to lower IOP in even the most difficult to treat glaucomas.
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.
Eyenovia is a late-stage ophthalmic biopharmaceutical company with a lead program for the prevention of myopia (nearsightedness) progression. Progressive myopia is a serious, site-threatening condition that may impact up to 5 million children in the United States, with similar numbers for Europe and many more in Asia. Through the use of our transformative ophthalmic delivery platform, Eyenovia is preparing a single, de-risked Phase 3 study of MicroPineTM that may lead to the first FDA-approved treatment for this condition.
Eyenovia makes new therapies possible. Our unique delivery platform uses breakthrough piezo-print technology for high-precision micro-dosing. Micro-dosing allows for fully effective therapies that may also avoid many tolerability and side-effect issues associated with traditional eye drop delivery.
Eyevensys is a clinical stage biotechnology company developing its innovative EyeCET platform to enable sustained intraocular production of therapeutic proteins to treat ophthalmic diseases.
Eyevensys’ EyeCET gene therapy technology uses electrotransfection to deliver protein coding plasmids, non-viral, into the ciliary muscle of the eye. This approach facilitates the sustained production of therapeutic proteins, localized within the ciliary muscle cells.
Eyevensys’ lead product EYS606, consists of Eyevensys’ proprietary electro-transfection injection system (ETIS) in combination with plasmid encoding for production of anti-TNFα, for treatment of non-infectious uveitis (NIU). EYS606 is currently in phase I/II clinical trial.
Eyevensys’ vision is to develop a pipeline of therapeutic proteins to address treatment of ophthalmic diseases such as RP, early stage Geographic Atrophy, macular ischemia and other ocular diseases.
Gemini Therapeutics is a biotechnology company focused on redefining dry AMD through the development of a series of first-in-class precision therapeutics. Each one of our therapeutic candidates is designed to directly compensate for the effect of a molecular abnormality found in patients with an unusually high risk genetic profile. Our disease-focused engine uses the process of translating precision therapeutics with unprecedented genotypic and phenotypic data as a method of drug discovery. We currently have 3 programs in preclinical development and our broad multimodal pipeline includes monoclonal antibodies, recombinant proteins and gene therapies. We are funded by leading life science investors and powered by academic partnerships around the world.
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.
Hemera Biosciences is a clinical stage gene therapy company whose mission is to preserve vision in patients with age related macular degeneration (AMD). Hemera’s one-time treatment called HMR59 works by inducing retinal cells to produce a soluble form of CD59 (sCD59) that blocks membrane attack complex (MAC), the final step of the complement cascade. MAC is elevated in eyes with macular degeneration and is associated with the cellular damage in AMD. HMR59 is currently being evaluated in two separate phase 1 clinical trials for advanced dry AMD (HMR-1001) and new onset Wet AMD (HMR-1002). A phase 2 Dry AMD study (HMR-2001) is planned for Q1 2019.
iSTAR Medical is a clinical-stage company focused on the development of novel ophthalmic implants for glaucoma. It has exclusive rights to a novel porous material called STAR(r) which exhibits outstanding anti-fibrotic properties therefore providing the foundation for the development of a new class of MIGS devices.
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYSTM (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which an NDA has been accepted for review by the FDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
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.
The company received European Union clearance to market LT-300 in mid-2018. LumiThera has established clinical improvements in vision outcomes in dry age-related macular degeneration (AMD) patients in three clinical studies with PBM. Retinal imaging with Optical Coherence Tomography (OCT) has shown anatomical changes providing disease-regression following PBM.
Mati is developing the Evolute platform - a non-invasive sustained drug delivery platform using punctal plugs as a delivery device. Products using the Evolute system are being developed for glaucoma, dry eye, allergy and inflammation. In prior studies, the Stable Fit punctal plug design has shown retention rates of 92% and 96% over a 12 week follow up period. Mati is currently conducting a Phase II trial of nepafenac in patients undergoing cataract surgery and positive interim results were announced in September. Mati will soon be undertaking a study using travoprost in patients with glaucoma and ocular hypertension and further plans to develop a steroid for post-cataract inflammation. This technology platform is well-supported with 114 patents issued in major countries around the world.
MC2 Therapeutics is a privately held late clinical stage emerging dermatology and eye care company.
Using its proprietary new vehicle PAD™ Technology MC2 Therapeutics is developing a pipeline of new topical drugs with unique clinical profiles designed for optimal patient compliance. Lead projects include MC2-01 Cream for psoriasis (US Ph3), MC2-03 Eye Drop for dry eye (pivotal Ph2) and MC2-02 Cream for uremic pruritus (launch expected in 2019).
Mynosys Cellular Devices
Mynosys Cellular Devices Inc. is a medical device company providing innovative solutions to help surgeons achieve perfection in cataract surgery. Our product Zepto®, is a unique micro-fabricated instrument that provides unmatched precision during surgery on a millisecond time scale to tackle routine and challenging cases with confidence and efficiency. Zepto® provides surgeons of all skill levels an inexpensive, easy to use, automated method for producing high quality anterior lens capsulotomies. Zepto® integrates seamlessly into the cataract surgery routine and its unique clinical device characteristics make it an attractive product platform having the unique capability of centering on the patient's visual axis, inter-operatively will significantly improve capsulotomy overlap of the IOL.
Inspired by a breakthrough discovery linking optometry and neurology, neurolenses are the first and only prescription lenses that add a contoured prism to bring the eyes into alignment, relieving stress on the trigeminal nerve. This nerve is the largest and most complex nerve connected to the brain, and when stimulated causes many of the symptoms people experience when using digital devices, reading or doing near work. Ninety-three percent of patients prescribed neurolenses found symptom relief. neurolens is headquartered in Costa Mesa, Calif.
Neurotech Pharmaceuticals, Inc. is a privately held biotechnology company developing transformative therapies for chronic eye diseases.
Neurotech’s core technology platform, Encapsulated Cell Therapy (ECT), is a novel drug delivery platform that enables long-term, continuous production of therapeutic proteins to the eye.
NT-501 ECT consists of encapsulated human cells genetically modified to secrete ciliary neurotrophic factor (CNTF) into the back of the eye to treat retinal degenerative diseases. CNTF has been shown to have neuroprotective effects on photoreceptors, and animal models of retinal degeneration have suggested that this neuroprotective effect slows vision loss due to photoreceptor death.
Neurotech is currently clinically studying NT-501 for the treatment of macular telangiectasia (MacTel) and glaucoma.
Neurotech has a dedicated, in-house manufacturing operations designed for clinical development and commercial launch.
Novaliq is a pharmaceutical company for the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology for ophthalmology.
With an initial focus on dry eye disease (DED), Novaliq offers an industry-leading portfolio addressing today’s unmet medical needs of millions of eye patients:
NovaTears® improves the signs and symptoms of dry eye disease (DED) and is marketed under CE-approval in Australia/New Zealand by AFT Pharmaceuticals and in Europe as EvoTears® by Ursapharm.
Two drugs are in the late stage of clinical development with results expected in Q3 2018:
- CyclASol®, an anti-inflammatory and immunomodulating drug for the treatment of DED with a demonstrated early onset of action and excellent tolerability, is being evaluated in the pivotal phase 2b/3 ESSENCE trial.
- NOV03, the first drug addressing evaporative DED associated with meibomian gland dysfunction (MGD), is being evaluated in the phase 2 SEECASE trial.
Headquartered in Heidelberg, Germany, Novaliq has an office in Cambridge, MA, USA. The long-term shareholder is dievini Hopp BioTech Holding, an active investor in Life and Health Sciences companies.
There is no better space within the eye to hold prosthetic implants than the lens capsule. This space, unlike any other in the eye, is the most precious real estate for developing future intraocular innovations. With this key insight in mind, Omega Ophthalmics has developed the Gemini Refractive Capsule, which functions as a self-expanding stent to hold the natural capsule open. This protected environment can receive additional implants of all types, including multiple IOLs, and creates the ideal space for biometric sensors, drug delivery devices, and more. By keeping the capsule open, we are able to add, exchange, or upgrade the patient’s vision as new technology becomes available. This platform creates a future proofed environment for protecting and enhancing vision over a patient's lifetime.
Oyster Point Pharma
Oyster Point Pharma is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapies to treat ocular surface disease.
Panoptes is a privately held clinical stage biotech company focused on developing novel therapies for the treatment of severe eye diseases with high unmet medical need.
Panoptes has an experienced team of development experts with a proven track record of developing and commercializing innovative products.
PanIJect, the lead program consists of an anti IL-17 anti IFN-g immunomodulatory small molecule, when injected into the vitreous ameliorates all signs of inflammation in animal models for uveitis. PanIject is currently in clinical phase 1b/2a development for non-infectious uveitis.
The second anti IL-17, IFN-g program PanIDrop is a completely novel natural, conservative free form of eye drops and showed efficacy in viral conjunctivitis and dry disease animal models. This ocular surface program will enter clinical development for the indication dry eye disease in 2018.
PowerVision has developed a fluid-controlled accommodating IOL designed to restore youthful vision. The FluidVision® AIOL provides True Accommodation™ by mimicking the eye’s natural accommodative process to transport fluids inside it, creating true shape change. The Company has shown in clinical trials that it can deliver clear vision at all distances.
Presbyopia Therapies (PT) has developed a disruptive therapeutic for the daily treatment of presbyopia.
LiquidVision™ Eye Drops are based on discoveries utilizing a proprietary vehicle with unique miotic combinations that may provide a powerful topical presbyopic treatment with both improved near and distance vision for total depth of field enhancement. Pilocarpine is not used.
LiquidVision™ eye drops represent a potential series of industry firsts:
• Improves near vision without blurring distance vision
• Compliments existing treatment options and is reversible
• Designed for monocular or binocular treatment
• Daily use (or as needed) for Lifestyle Enhancement
• 30 minute on-set, 4+ hour duration
FDA clinical trial phase 2b complete. Top line data available. Primary efficacy and safety endpoints met, with statistically significant improvement shown.
We are a leading, clinical-stage stem cell business. Our primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.
In 2011, Sight Sciences was founded to change the way the practice of ophthalmology and optometry thinks about and treats the leading causes of eye disease. Supported by leading medical technology and private equity investors, Sight Sciences operates two business lines: surgical and non-surgical systems. Its surgical product portfolio consists of the OMNI™ Surgical System, TRAB®360 and VISCO360® for use by ophthalmologists. Its non-surgical product portfolio consists of its TearCare™ technologies for use by ophthalmologists and optometrists.
Silk Technologies is developing SDP-4, a novel biotherapeutic, designed to treat the signs and symptoms of Dry Eye Disease (DED) through a dual-mechanism of action. Pre-clinical data demonstrates SDP-4 inhibits inflammatory pathways known to drive DED symptomatology, while simultaneously enhancing spreading and wetting of the ocular surface to improve patient comfort during use due to the protein chemistry of the product. Silk Technologies has SDP-4 currently in pre-clinical development with an anticipated Phase II clinical trial starting the first quarter of 2019. The SDP-4 eye drop is preservative free, aqueous, and highly stable at room temperature. The company has issued patents protecting their proprietary silk-derived protein material, and is currently supported through private equity and Federal Government grant funding.
Translatum Medicus Inc
Translatum Medicus inc is a pre-clinical drug development company uniquely focusing on macrophage biology in the treatment of blinding eye disease, first targeting “dry” Age Related Macular Degeneration (AMD) a leading cause of irreversible blindness.
Translatum’s patented lead drug candidate, TMi-018, is a first-in-class transcriptional regulator of macrophage polarization that is dose-dependently efficacious in pre-clinical models of Geographic Atrophy, the end-stage of dry AMD. It has demonstrated stability and suitability for extended delivery, and is safe in non-GLP toxicity studies. With active pharmaceutical ingredient (API) production underway, and a strong leadership team that includes extensive large pharma and startup experience, the company is currently raising Series A funds to move to early phase clinical trial.
Trefoil Therapeutics is developing engineered FGF-1 compounds to treat corneal endothelial dystrophies. The lead compound is unique in addressing multiple unmet needs in corneal disease by mimicking natural biologic processes. The compound is protected by a broad patent portfolio.
The first indication is an intracameral injection for the treatment of Fuchs Dystrophy. Also in development is a topical formulation of TTHX1114 that will treat a number of ulcerative conditions on the front of the cornea.
Trefoil has completed a pre-IND meeting and is preparing an IND for submission in H2, 2019. for the front of the cornea indication. The company completed a Series 1 financing in 2016, led by Hatteras Venture Partners.
The therapeutic categories under development offer an efficient and quick development pathway.
Public Company Spotlight
Aerie Pharmaceuticals, Inc. is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye. Aerie's first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, is available in the United States. The PDUFA goal date for Aerie’s second product Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a fixed-dose combination of Rhopressa® and latanoprost, is March 14, 2019. Aerie is expanding globally and developing additional product candidates in ophthalmology, including for wet AMD and DME.
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 biotech developing therapies for neurodegenerative diseases. Its pipeline leverages two technology platforms, the Mitochondrial Targeting Sequence and Optogenetics. GenSight Biologics’ lead candidate, GS010, is in Phase III trials in LHON, a rare mitochondrial disease that leads to irreversible low vision in young adults.
Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat ophthalmic diseases, with a focus on orphan and age-related retinal diseases.
Opthea (ASX:OPT) is developing OPT-302, a VEGF-C/D inhibitor for neovascular AMD and DME. VEGF-C/D promote vessel growth and leakage and may contribute to sub-responsiveness to VEGF-A inhibitors. Opthea has reported outcomes from a Phase 1/2a trial in nAMD (n=51) that evaluated safety and clinical activity of OPT-302 as a monotherapy and in combination with ranibizumab in treatment-naïve and prior-treated patients. OPT-302 was well tolerated and data suggest biological activity with improvements in visual acuity and retinal swelling, suggesting additional clinical benefit with dual targeting of VEGF-A and VEGF-C/D. Opthea is currently recruiting patients in two randomised, controlled studies, including a Phase 2b trial of OPT-302 in combination with ranibizumab for nAMD and a Phase 1b/2a trial of OPT-302 in combination with aflibercept for persistent DME.
Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing treatments to preserve vision in patients with diseases affecting the back of the eye. The company has built a diverse portfolio of disease-modifying therapies, including treatments for diabetic eye disease, a leading cause of blindness in people of working age worldwide. Headquartered in Leuven, Belgium, Oxurion is listed on the Euronext Brussels exchange under the symbol OXUR. In the US, Oxurion NV operates ThromboGenics inc. as a subsidiary company.
GoCheck’s apps detect common eye diseases early, while they can still be treated.
Our first product, GoCheck Kids, serves over 3,500 pediatric teams in the U.S. and Europe in their quest to prevent vision impairment, the most prevalent disabling condition among children in many countries including the U.S. GoCheck Kids made early screening affordable, reducing the cost by over 60%, by leveraging the iPhone’s manufacturing scale. It’s also FDA-registered and CE cleared.
Eight of the leading children's hospitals (e.g. Harvard, Stanford, etc.) voted GoCheck the #1 global pediatric health startup at SXSW 2018. Our Chief Innovation Officer is Harvard M.D. and MIT Ph.D. David Huang, co-inventor of OCT. GoCheck is backed by Interwest Partners (89 IPOs) and Marc Benioff, founder/CEO of Salesforce.
Notal Vision is an Artificial Intelligence driven, Cloud based company that has created an ecosystem to support the early detection and personalized treatment of vision threatening diseases.
ForeSee Home leverages the ecosystem, seamlessly connecting patients to their eye care professional to monitor and detect the switch of patients from Dry to Wet AMD at the earliest possible stage.
Notal Vision is developing a home based OCT platform to personalize treatment for patients with Wet AMD,DME and RVO.
Ophthorobotics is developing an assistive system that injects medication intravitreally. By providing an automated system with an integrated local sterile environment and consumables to hospitals, we can increase safety for patients, decrease procedure times, allow for integrated data storage and documentation, and reduce costs for medical staff and operating rooms. The intended system allows for a fully automated injection that is initiated via a computer and monitored by a remote ophthalmic surgeon via a visual-auditory communication system. As the injection needle is guided through software, including eye-tracking and iris recognition, the only component that touches the eye is the injection needle. Precision and safety are fundamental to the system design and do not depend on the manual dexterity of medical staff using a handheld system.
Tracery is a clinical stage ocular imaging & health tech company that harnesses image-based and non-image-based health data, and Artificial Intelligence for the development of new diagnostic tools for Precision Drug Development, first focusing on Age Related Macular Degeneration (AMD).
Tracery’s platform leverages advanced computing to identify the right person, for the right clinical trial, targeting the right pathway with the right chemistry. We do this by: (1) stratifying novel phenotypes using our proprietary functional imaging method and database, (2) correlating these with the patient’s molecular makeup and health data, and (3) honing potential therapeutics through in silico drug design. By centralizing through the cloud, Tracery aims to provide data, information and answers as a service providing new biomarkers in 2 years rather than 10.
Innovation in healthcare is hindered by the time and cost of bringing new therapeutics and devices to market. Verana Health, formerly known as DigiSight Technologies, is building a cutting-edge platform for life science innovation that utilizes regulatory-grade specialty data sets. The Verana platform combines longitudinal real world data from electronic health records with advanced analytics to support rapid development of new pharmaceuticals and devices, and includes physician-facing solutions to enable enhanced patient care. This platform initially utilizes information from the IRIS Registry, the largest specialty-specific clinical database in medicine, representing 50+ million patients, 200+ million patient encounters, and billions of data points, to deeply understand patient needs and to optimize drug and device development from clinical research through to post-commercialization.