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The MIGS Regulatory Path

under the lens..

Sean Ianchulev, MD MPHClinical Associate Professor, UC San Francisco

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Sean Ianchulev, MD MPHClinical Associate Professor, UC San Francisco

Disclosures:

Chief Medical Officer, Transcend Medical (acquired by Alcon 2016)Partner, PME VenturesBoard Member: Eyenovia, Kurobe, Iantech

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Stent Technology arriving to OphthalmologyThe Next Frontier

NeurovascularCardiovascularPulmonary

GastrointestinalUrological/Gynecological

Peripheral Vascular

OphthalmologyMIGS

Before 2000

Tube Trab

Glaucoma Surgical Options

2010

Glaucoma Surgical Options

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MIGS LANDSCAPE ten years later….

• Innovation returns to glaucoma surgical treatments• MIGS is establishing a new frontier in surgical glaucoma• Strong pipeline of MIGS devices on the horizon

• Transformative innovation enabled by:• Clarity of the regulatory PMA/510K process• Strong clinical and regulatory science &

development framework• Prospective stability/predictability of the regulatory

pathway

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The beginning of the MIGS PMA

• First MIGS PMA study: 2005-2010 (iStent®, N240+)• First MIGS Approval: 2012 (iStent®)• Second MIGS PMA study: 2009 -2015 (CyPass®, N505)

CyPass®iStent®

2005 2009 2016

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iStent®

2005 2009 2016

What changed?

1. Change in size of recommended PMA validation trial

2. Change in recommended endpoints

3. Change in clinical trial methodology

CyPass®

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Sample Size:

• Randomized subjects – 2X the original (240500+)• Enrollment can total N 900 (screen failures from

wash-out)

N = 240

COMPASS trial

N = 505

iStent® trial

N = 276 ABC trialN = 212 TVT trial

N = 255 EMGT trial

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Follow-up & Clinical Outcomes Measurement

• Primary endpoints for efficacy: 24 months (12 months if justified)

• Safety Follow-up : 24 months• Terminal wash-out required: 12 and 24 months• Diurnal IOP measurement post-washout at B/L, 12

and 24M

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How it changed?

1. Learning on both sides: FDA and industry

2. Workshops, ANSI, FDA guidance

3. Tremendous effort on all sides

The Effort: Stories from the Transcend Reg. Dept.

1. COMPASS protocol version P (n=16)

2. 7+ years of constant exchange with the FDA

3. 7,000+ pages of correspondence and submissions

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Terminal Wash-out

Primary EP

Sample Size

The Bottom Line: It takes hard work for Level 1 clinical evidence and validation….

Diurnal IOPStrict Meds Rescue

Criteria

240+

12M

NO

NO

NO

505+

24M

YES

Yes

Yes

BEFORE AFTER

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IT is a PMA World: The age of the PMA highway vs the 510K alley..

Stand AloneREFRACTORY

510KStand Alone

NON-REFRACTORY

PMAPhaco ComboNON-REFRACTORY

PMAStand Alone

NON-REFRACTORY

PMA

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Today: it’s easy.....(right?!) Just follow the guidance....