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PMA P010018/SUPPLEMENT 5

PMA P010018/SUPPLEMENT 5 . FDA PRESENTATION.

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PMA P010018/SUPPLEMENT 5

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  1. PMAP010018/SUPPLEMENT 5 FDA PRESENTATION

  2. Temporary induction of myopia (-1D to -2D) to improve near vision in the non-dominant eye of presbyopic hyperopes or presbyopic emmetropes, via spherical hyperopic treatment of up to 3.00D, in patients 40 years of age or greater with a documented stability of refraction for the prior 12 months, as demonstrated by a change of <0.50D in spherical and cylindrical components of the manifest refraction, and with ≤0.75D of cycloplegic refractive cylinder and with a successful preoperative trial of monovision or history of monovision wear (ie., dominant eye corrected for distance vision and non-dominant eye corrected for near vision). Indication for Use • Differences from approved indication: • Patient population—emmetropic and hyperopic presbyopes • Refractive target—myopia (-1D to -2D) • Binocular outcome—monovision • Similarities to approved indication: • Same surgical procedure and treatment patterns (8, 16, 24, 32 spots) • Same magnitude of treatment (0.75D to 3D sphere)

  3. Accountability--eyes treated for near * 136 full corrections, 14 partial corrections

  4. Undercorrection of MRSE Undercorrection >1D by spot pattern * 52% of eyes treated with 32 spots achieved J3 or better at month 6, 60% month 12

  5. Accuracy of MRSE* *excludes 11 eyes with intraoperative treatment for management of induced cylinder Accuracy by treatment pattern, month 6

  6. Accuracy of MRSE* * excludes 11 eyes with additional intraoperative spots for management of induced cylinder Accuracy by age, month 6 * 41/45 of subjects ≥55 years received full correction for near

  7. Uncorrected Near Visual Acuity (UCVA) 1 1 excludes 11 eyes with additional intraoperative spots and 14 partial corrections 2 82% with re-analysis excluding eyes treated with 32 spots Near UCVA by spot pattern, month 6 * N=2 eyes

  8. Uncorrected Near Visual Acuity (UCVA) 1 1 excludes 11 eyes with additional intraoperative spots and 14 partial corrections 2 82% with re-analysis excluding eyes treated with 32 spots Near UCVA by age, month 6

  9. Comparison of EffectivenessHyperopes vs. Emmetropes • 65% of hyperopes received 32 spots (vs. 8% of emmetropes), remainder recieved 24 spots

  10. Spectacle / Contact Lens DependenceOriginal Questionnaire Responses

  11. Induced Change in Cylinder Absolute Magnitude of Cylinder

  12. FDA Questions for Panel Discussion • Is the length of follow-up sufficient to demonstrate reasonable assurance of safety and effectiveness for the proposed indication? • Is the magnitude of induced cylinder and axis shift, and the associated effect on UCVA, clinically acceptable for the proposed indication? • Is the rate of undercorrection >1D clinically acceptable? Are there subgroups of the PMA cohort for which this outcome is not acceptable? • Are the reduced accuracy to target refraction and poorer near-UCVA outcomes (monocular and binocular) acceptable to justify the risk of elective surgery with “temporary” results, and is the near UCVA correction achieved clinically useful in the following groups? If not, how do you suggest the indication and/or labeling be modified… • for eyes treated with the 32-spot pattern? • for subjects >55 years of age? • for hyperopic patients? • for other populations or magnitude of refractive correction? • Do the spectacle dependence rates for near activities support approval for the requested indication in a presbyopic population? • Do the safety and efficacy data support approval for the requested indication? If not, what indication does the data support? • Do you have additional labeling recommendations, descriptive text or data? Should additional data tables be added to the physician and/or patient labeling?

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