AlphaCor Outcomes Update

1
AlphaCor Outcomes Update
R Doyle Stulting MD PhD On behalf of the
AlphaCor Scientific Advisory Board GJ Crawford1,
J Dart2, G Grabner3, CR Hicks1, EJ Holland4, RD
Stulting5, D Tan6. 1 Lions Eye Institute, Perth,
Australia 2 Moorfields Eye Hospital, London, UK 3
Landesaugenklinik, Salzburg, Austria 4 Cincinnati
Eye Institute, Cincinnati, USA 5 Emory Laser
Vision, Atlanta, USA 6 Singapore National Eye
Center, Singapore Presenting author has no
financial interest. Authors Hicks and Crawford
have a financial interest with the manufacturer
of AlphaCor, CooperVision Surgical, through
support of departmental funding, travel and
research. AlphaCor is cleared by FDA and has
international approvals but some aspects of
patient management have never been specifically
approved for use in conjunction with any KPro.
2
Purpose and Background

• Review AlphaCor data to evaluate device safety
  and efficacy
• AlphaCor is a 7.0 mm diameter, one-piece,
  non-rigid synthetic cornea for those at too high
  risk for PK with donor tissue standard and
  aphakic powers
• Central transparent optic chemically fused with
  surrounding biointegratable skirt
• Implanted within the corneal stroma

3
Study Design and Surgery

• Prospective, non-randomized
• Pre-op and post-op data compiled and updated
• All cases included, pre and post regulatory
  approvals
• Stage I (typically 35-50 minutes)
• Lamellar pocket created and 3.5 mm opening
  trephined in central posterior lamella
• AlphaCor positioned and pocket closed
• Stage II (after 3 months)
• Opening of anterior lamella of cornea

4
Data

• This presentation based upon data to 28th Sep
  2005
• Includes all 277 AlphaCor implantations by 78
  surgeons 46 trial cases, 231 post-trial
• 21.7 Australasia, 11.2 Europe, 67.1 Americas
• 88.8 for on-label indications, 11.2 off-label
• Includes 14 second devices 1 bilateral
  implantation

5
Follow-up (device in situ)

• Ranges from 0.1 months to 83 months
• Mean follow-up is 14.6 months, median 12.0

6
Pre-operative Patient Profile

• 61.0 male, 39.0 female
• Age 1-91y, mean 58.1 years
• 13.0 Afro-Caribbean, 14.8 Asian/Inuit, 72.2
  Caucasian
• 16.2 diabetic (9.7 IDDM)
• 16.6 systemic hypertension

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Pre-op Profile

• 18.1 aphakic, 54.5 PC IOL, 6.1 AC, iris or
  sutured
• 56.0 glaucoma (0.4 laser, 9.4 trabeculectomy,
  24.9 tube)
• 36.8 history bullous keratopathy
• 6.9 aniridia
• 24.9 history trauma/chemical
• 12.1 history bacterial keratitis, 1.3 fungal
  keratitis
• 1.8 Descemetocoele, 2.2 silicone oil, 1.8
  ICE
• 8.0 HSV
• 2.4 severe dry eye/SJS, 14.1 moderately dry

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Previous Failed Grafts
AlphaCor recipients had a mean of 2.4 prior
failed grafts
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Outcomes ComplicationsStromal melting

• Falling incidence (24.7 2003, 10.6 2004)
• Off-label dry eyes at increased risk (p lt 0.001)
• MPG-therapy significantly protective (p lt 0.001)
• History of HSV and cataract surgery not risk
  factors if MPG prescribed
• Progressive melts treated with lamellar graft or
  reversed to PK

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Outcomes ComplicationsRPM

• An inflammatory/fibrous re-closure of the
  posterior lamellar opening in 14.4 cases
• Associations Afro-Caribbean (p 0.001),
  systemic HT (p 0.014), DM no longer a
  significant risk factor, possibly reflecting
  successful prevention by steroids in this
  previously high-risk group
• Managed by NdYag or surgery /- heparin and rTPA

11
Outcomes ComplicationsOptic spoliation or damage

• Intra-gel deposit
• brown, 3.2 (smoking, p 0.019)
• calcific, 5.4 (concurrent prescription of
  topical steroids and beta-blockers, p lt 0.001)
• fungal invasion 1 confirmed case (0.4) in RGP
  wearer)
• Damage to optic necessitating replacement in 1
  case (0.4)
• Surface spoliation (5.4) related to dry eye (p lt
  0.001) appears prevented by bandage lens and may
  be removable with CL cleaners

12
Outcomes ComplicationsPoor primary
biointegration

• 8 cases (2.9) where aqueous leakage noted at
  Stage II, or fluid seen on imaging and stage II
  deferred
• Imaging fluid track or poor apposition/over-large
  pocket
• Associated with reported perioperative
  difficulties (p lt 0.001) no other significant
  associations
• Natural history is slow resolution additional
  sutures helpful in some cases

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Outcomes ComplicationsOther

• Glaucoma data suggest control does not worsen
  after AlphaCor history glaucoma does not affect
  probability AlphaCor retention
• Vitritis 2 cases (0.7), no identified risk
  factors
• Endophthlamitis 2 cases (0.7), after prolonged
  melt/leak
• Rhegmatogenous RD 1 case (0.4), related to
  RPM surgery

14
AlphaCor Probability of Survival

• 1-year 81
• 2-year 60

15
Visual Acuity Outcomes

• Pre-op
• Range PL- 20/200
• Mean HM
• (pre-existing macular disease 26.0, glaucoma
  56.0 no view 21.4)
• Best BCVA post-op
• Range PL- 20/20
• Mean 20/200
• Mean gain 2 lines BCVA
• Mean BCVA matches mean BCVA achieved from
  previous graft before failure (paired t-test)

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Comparison with 1 year graft survival after gt4
PFG
AlphaCor data (MPG-Rx, on-label cases, N
44) PK data from ACGR 2004 Report N 79 with 4
or more PFG
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Conclusions

• With 337 patient-years of experience, many risk
  and protective factors have been identified
  demonstrates merits of continued and inclusive
  data collection
• Low risk of sight-threatening complications
  reversible procedure does not worsen/provoke
  glaucoma
• Better chance of success than donor PK in high
  risk cases
• Mean VA achieved matches that from previous graft
• Long term data must continue to be collected for
  better understanding of the benefits and
  limitations of this technology

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The Scientific Advisory Board Gratefully
Acknowledges Contributors of Data

• Aasly K, Afshari N, Akpek E, Aldave A, Aquavella
  J, Awwad S, Bleckmann H, Bobrow J, Bokosky J,
  Caparossi A, Caudill J, Channa P, Chen P, Chern
  K, Chodosh J, Cohen I, Cohen S, Conners M, Cowden
  J, Crawford G, Dart J, Daya S, Dhaliwal D, Downie
  N, Dunn S, Eguchi H, Eiferman R, Fulcher S,
  Geerling G, Gillette T, Goins K, Gondhowiardjo T,
  Goodwin L, Gorovoy M, Grabner G, Gritz D, Gulani
  A, Hamilton S, Hardten D, Hirst L, Holland E,
  John T, Karbassi M, Katsev D, Kaufman H, Kim J,
  Lahner W, Lam D, Leahey A, Macsai M, Mah F,
  Malecha M, Manche E, Mayers M, McCaa C, Moshifir
  M, Pangalinan R, Parker J, Pflugfelder S, Price
  F, Prosdocimo G, Raber I, Randleman B, Rapisarda
  A, Rapuano C, Remejier L, Rodriguez L, Roszival
  P, Rotkis W, Silverstein S, Snibson G, Song J,
  Stulting RD, Sutphin J, Sutton G, Taravella T,
  Tauber S, Tan D, Tran U, Wang M
• Honorary member Scientific Advisory Board
• Clinical Investigator in Regulatory Trials