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眼疾标靶

本会议以眼疾标靶化为主题,将讨论新标靶及疾病途径、药物传输最新方法、前眼部与后眼部眼病可期高疗效的新治疗法。其中特别聚焦基因治疗、干细胞治疗、以及已确立的血管内皮生长因子 (VEGF) 为标靶的单剂疗法以外的疗法。另外也将讨论青光眼、湿性与乾性老年性黄斑病变、糖尿病黄斑症、视网膜病变、色素性视网膜炎等各种眼睛疾病。


Final Agenda

Day 1 | Day 2

Wednesday, September 27

11:50 am Conference Registration Open

12:20 pm Plenary Keynote Program

(visit Plenary-Keynotes for complete details)

2:00 Refreshment Break in the Exhibit Hall with Poster Viewing

Gene Editing & Gene Therapy Breakthroughs for Ocular Disorders

2:45 Welcome Remarks

Lee Yuan, Conference Director, Cambridge Healthtech Institute

2:50 Chairperson's Opening Remarks

Bo Liang, Ph.D., President, R&D, IVIEW Therapeutics, Inc.

2:55 Lentiviral Gene Therapy for Ocular Disease

Scott Ellis, Ph.D., Head, Early Development, Oxford BioMedica

Oxford BioMedica's gene therapy for Parkinson's disease (ProSavin®) was the first ever lentiviral gene therapy directly administered in man, and its shared LentiVector® gene therapy platform is the basis of three ocular gene therapies currently under clinical evaluation as well as several earlier-stage programs in development. This platform has consistently demonstrated an excellent safety profile and uniquely has been shown to mediate robust and durable therapeutic gene expression in the eye in patients over several years. This talk will review our previous experience and current plans using the LentiVector® platform in the development of gene therapies for chronic ocular diseases.

3:25 Intravitreal Gene Therapy for Dry AMD

Jay_DukerJay S. Duker, M.D., Director, New England Eye Center; Professor and Chairman, Department of Ophthalmology, Tufts Medical Center, Tufts University School of Medicine; Founder, Hemera Biosciences

Dry age related macular degeneration (AMD) represents a significant cause of visual loss in the elderly but lacks an approved therapy. Inhibiting the complement system locally within the eye shows promise as a therapeutic intervention. Hemera Biosciences' lead product, HMR59, is an AAV2 based gene therapy delivered intravitreally that blocks membrane attack complex (MAC) through the local production of soluble CD59. HMR59 is currently being tested in a Phase I clinical trial in eyes with severe dry AMD and geographic atrophy (GA).

3:55 Sponsored Presentation (Opportunity Available)

4:25 Refreshment Break in the Exhibit Hall with Poster Viewing

5:00 Development of an Intravitreal AAV-Based Treatment for Wet Age-Related Macular Degeneration

Mehdi Gasmi, Ph.D., CTO & CSO, Adverum Biotechnologies

5:30 Optogenetic Therapy for Retinal Dystrophies

Anne_DouarAnne Douar, Ph.D., Project Director, GenSight Biologics

Optogenetics aims at transferring a gene encoding for a light-sensitive molecule to restore photosensitivity in retinal cells that are still wired into the inner retina layers. The GS030 treatment combines such gene therapy based approach in combination with a photo-stimulating device to potentiate the biologics' activity. Translational research has allowed to demonstrate the proof of concept in rodent and non-human primate models and to establish the safety profile of the product, paving the way to the first in human clinical trial currently in preparation.

6:00 A CRISPR Medicine Approach for Treating Leber Congenital Amaurosis Type 10

Gerald_CoxGerald F. Cox, M.D., Ph.D., CMO, Editas Medicine

Leber congenital amaurosis type 10 (LCA10) is a rare infantile-onset retinal dystrophy caused by autosomal recessive mutations in the CEP290 gene. In photoreceptors, CEP290 is required for cilia formation, maintenance of outer segments, and cell viability. The most common LCA10 mutation, c.2991+1655A>G, creates a cryptic splice acceptor site in intron 26 that causes missplicing and leads to a non-functional protein. CRISPR/Cas9 is a genome editing tool that cuts and modifies DNA at precise locations. This new technology is being applied to correct the underlying common genetic defect in LCA10, with the goal of providing a durable treatment that restores vision to patients.

6:30 Close of Day

6:30 Dinner Short Course Registration*

SC14: Commercialization of Ophthalmic Drugs and Devices - Detailed Agenda

Instructors:

Emmett Cunningham, Partner, Clarus Ventures

Glenn Noronha, Ph.D., CSO, Clearside Biomedical, Inc.

Rick Beckman, M.D., CMO, Clearside Biomedical, Inc.

*Separate registration required.

Day 1 | Day 2

Thursday, September 28

7:30 am Registration Open

8:00 Interactive Breakout Discussion Groups with Continental Breakfast

Grab a cup of coffee and join a breakout discussion group. These are informal, moderated discussions with brainstorming and interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic. Details on the topics and moderators are available on the conference website.

Gene Editing & Gene Therapy Breakthroughs for Ocular Disorders

9:00 Chairperson's Remarks

Naj Sharif, Ph.D., FARVO, FBPhS, Executive Director; Head, Global Alliances & External Research, Santen, Inc.

9:05 Investigational Gene Therapy for Inherited Retinal Dystrophies Due to Biallelic Mutations in RPE65

Daniel_ChungDaniel Chung, D.O., Clinical Ophthalmic Lead, Sparks Therapeutics

This presentation is a review of the latest results from a Phase III, open-label, randomized, controlled trial evaluating the safety and efficacy of AAV2-hRPE65v2 (SPK-RPE65) to treat inherited retinal dystrophies caused by biallelic mutations in the RPE65 gene, following adeno-associated virus mediated gene transfer to the retina.

Novel Targets & Disease Pathways

9:35 Novel Glaucoma Drugs and Devices: Paving Paths towards Retinoprotection

Naj_SharifNaj Sharif, Ph.D., FARVO, FBPhS, Executive Director; Head, Global Alliances & External Research, Santen, Inc.

Whilst prostaglandin FP-receptor agonists are mainstay current therapeutics used to treat ocular hypertension (OHT) associated with primary open-angle glaucoma (POAG), a number of novel new drugs are on the horizon awaiting FDA approvals. There has also been a recent revolution in the development and clinical utility of minimally-invasive-glaucoma-surgery (MIGS) devices to lower intraocular pressure (IOP) for managing OHT/POAG. However, since reduction of IOP does not always reduce or prevent vision loss from POAG, the holy-grail of neuroprotective therapy, alone or in conjunction with IOP lowering, still represents an achievable goal. These aspects will be addressed in this presentation.

10:05 Plasma Kallikrein Inhibitors for the Treatment of Diabetic Retinopathy/Diabetic Macular Edema

Timothy_ShiauTimothy Shiau, Ph.D., Senior Scientist, Chemistry, Verseon

Topically-applied plasma kallikrein inhibitors are a promising mechanism of slowing, stopping, or reversing diabetic macular edema. We present a series of small molecule, nanomolar inhibitors of plasma kallikrein and progress toward in vivo efficacy in a diabetic retinopathy model following topical dosing.

10:35 Coffee Break in the Exhibit Hall with Poster Viewing and Poster Competition Winner Announced

11:20 Plasma Kallikrein Inhibition as a VEGF-Independent Treatment for Diabetic Macular Edema

Ed_FeenerEdward P. Feener, Ph.D., Co-Founder and CSO, KalVista Pharmaceuticals

This talk will present the scientific and clinical rationale for targeting plasma kallikrein as a novel VEGF-independent treatment for diabetic macular edema (DME). Increased plasma kallikrein levels have been identified in vitreous from DME patients. Preclinical studies have demonstrated that plasma kallikrein induces retinal edema via a VEGF-independent mechanism. KalVista has discovered and developed an intravitreally administered plasma kallikrein inhibitor, KVD001. The Company has successfully completed its first-in-human study in patients with DME and is preparing for Phase II studies.

Drug Delivery Methods for Ocular Disorders

11:50 The Potential for Treatments for Posterior Segment Eye Diseases Using a Suprachoroidal Injection Approach

Glenn_NoronhaGlenn Noronha, Ph.D., CSO, Clearside Biomedical, Inc.

We will outline the progression of the development of suprachoroidal administration of drug candidates with potential for the treatment of posterior segment eye diseases. Clearside has ongoing Phase III studies in noninfectious uveitis and in retinal vein occlusion, and a Phase I/II trial in diabetic macular edema as part of continued development. We will trace the progression from bench to animals through to clinical efforts, to make the case for this approach for the treatment of eye diseases.

12:20 pm Sponsored Presentation (Opportunity Available)

12:50 Session Break

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:50 Refreshment Break in the Exhibit Hall with Poster Viewing

2:35 Chairperson's Remarks

Sharon Klier, Vice President, Ophthalmology, Medical, Quark Pharmaceuticals

2:40 Novel Injectable Products for Treatment of Ocular Diseases

Ming Yang, Ph.D., Director, Research, Graybug Vision

Graybug Vision is developing novel products for the treatment of people with ocular diseases. The company's proprietary injectable products are designed to enable less frequent administration and to reduce the burden of treatment for patients with ocular diseases. The company's lead product, GB-102, consists of an approved receptor tyrosine kinase inhibitor, sunitinib malate, that inhibits multiple pathogenic angiogenesis pathways known to be involved in the choroidal neovascularization, the cause of neovascular AMD (nAMD). Graybug Vision has incorporated sunitinib in its novel delivery system to allow a potential twice per year injection, dramatically reducing the current burden of treatment for patients and physicians. Graybug Vision has also developed a library of compounds to treat glaucoma, a leading cause of progressive, irreversible vision loss worldwide, by lowering intraocular pressure alone or in combination with neuroprotection when injected twice per year into the subconjunctiva.

3:10 Sustained Micro-Dose Drug Delivery with Injectable Inserts: Current Status and Emerging Applications

Dario_PaggiarinoDario A. Paggiarino, M.D., Vice President, CMO, pSivida

Sustained linear-release, micro-dose delivery of antiviral and anti-inflammatory agents has evolved over the years from surgically implanted to injectable miniaturized inserts. The same technology showing long-term clinical benefit in past approved products is now being developed in the delivery of new agents and ocular conditions for which micro-dosing would be key in providing extended control of disease pathophysiology.

3:40 Session Break

3:55 Intracanalicular Inserts for Drug Delivery - Dextenza and Its Applications in Managing Ophthalmic Diseases

Amar_SawhneyAmar Sawhney, Ph.D., Chairman, President and CEO, Ocular Therapeutix

Intracanalicular inserts provide a promising site for non-invasive placement of drug products to deliver courses of therapy for several ophthalmic diseases. Dextenza promises to be the world's first single dose drug therapy to deliver the entire course of medication with a single placement. It is being developed for pain and inflammation following ocular surgery, allergic conjunctivitis, and other inflammatory conditions. Additionally, Ocular Therapeutix is investigating drugs for the treatment of ocular hypertension and glaucoma with a single placement that could provide therapy for up to 3 months. This talk will explore the design, development, and clinical data surrounding these drug products.

4:25 PANEL DISCUSSION: Pros and Cons of Ocular Drug Delivery Methods

Moderator:
Elias_ReichelElias Reichel, M.D., Professor and Vice Chair, Tufts University School of Medicine; Director, Vitreoretinal Diseases and Surgery Service, New England Eye Center; Founder, Hemera Biosciences


Panelists:
Glenn_NoronhaGlenn Noronha, Ph.D., CSO, Clearside Biomedical, Inc.


Ming Yang, Ph.D., Director, Research, Graybug Vision

Amar_SawhneyAmar Sawhney, Ph.D., Chairman, President and CEO, Ocular Therapeutix


Dario_PaggiarinoDario A. Paggiarino, M.D., Vice President, CMO, pSivida

The panelists will discuss key considerations when determining the right ocular drug delivery method for their products and challenges that they faced. There will also be general discussion about the pros and cons of different delivery methods for the eye.


4:55 Close of Conference

Day 1 | Day 2

 

* 活动内容有可能不事先告知作更动及调整。

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