SPOTLIGHT ON MIGS - Transcend
-
Upload
healthegy -
Category
Healthcare
-
view
610 -
download
0
Transcript of SPOTLIGHT ON MIGS - Transcend
1
The MIGS Regulatory Path
under the lens..
Sean Ianchulev, MD MPHClinical Associate Professor, UC San Francisco
2
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
3
Stent Technology arriving to OphthalmologyThe Next Frontier
NeurovascularCardiovascularPulmonary
GastrointestinalUrological/Gynecological
Peripheral Vascular
OphthalmologyMIGS
Before 2000
Tube Trab
Glaucoma Surgical Options
2010
Glaucoma Surgical Options
7
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
8
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
9
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®
10
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
11
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
12
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
13
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
14
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
15
Today: it’s easy.....(right?!) Just follow the guidance....