PMA P010018/SUPPLEMENT 5 FDA PRESENTATION

Indication for Use 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). 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)

Accountability--eyes treated for near Month 6Month 9Month 12 eyes available146/15094/15077/150 accountability97%96%95% * 136 full corrections, 14 partial corrections Treatment patternNumber of eyes 8-spot (0.75D to 0.875D)4 16-spot (1.0D to 1.625D)42 24-spot (1.75D to 2.25D)51 32-spot (2.375D to 3D)42

Undercorrection of MRSE 6 months9 months12 months >1D24%19%16% >2D5%4%3% Undercorrection >1D by spot pattern 8-spot16-spot24-spot32-spot * Month 60%10%8%59% Month 120%3%11%63% * 52% of eyes treated with 32 spots achieved J3 or better at month 6, 60% month 12

Accuracy of MRSE* 6 months9 months12 months ± 0.5 D49%59%61% ± 1.0 D76%81%84% ± 2.0 D95%96%97% 8-spot16-spot24-spot32-spot ± 0.5 D (target 50%) 50%67%65%15% ± 1.0 D (target 75%) 100%90%92%41% ± 2.0 D100% 85% Accuracy by treatment pattern, month 6 *excludes 11 eyes with intraoperative treatment for management of induced cylinder

Accuracy of MRSE* 6 months9 months12 months ± 0.5 D49%59%61% ± 1.0 D76%81%84% ± 2.0 D95%96%97% <50 years (n=44) 50 to <55 (n=55) ≥ 55 years (n=45)* ± 0.5 D (target 50%) 61%53%33% ± 1.0 D (target 75%) 86%78%62% ± 2.0 D100%96%89% Accuracy by age, month 6 * excludes 11 eyes with additional intraoperative spots for management of induced cylinder * 41/45 of subjects ≥55 years received full correction for near

Uncorrected Near Visual Acuity (UCVA) 1 6 months9 months12 months J1 or better45%46%34% J3 or better78% 2 81%78% 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 8-spot *16-spot24-spot32-spot J1 or better50%39%59%34% J3 or better50%83%82%66% * N=2 eyes

Uncorrected Near Visual Acuity (UCVA) 1 6 months9 months12 months J1 or better45%46%34% J3 or better78% 2 81%78% 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 < 50 years50 to <55≥ 55 years J1 or better56%46%34% J3 or better90%78%66%

Comparison of Effectiveness Hyperopes vs. Emmetropes Emmetropes (n=87) Hyperopes * (n=60) Month 6Month 12Month 6Month 12 Accuracy ± 0.5 D61%71%32%38% Accuracy ± 1.0 D87%96%59%62% UCVA J3 or better80% 74%73% Binocular J1 and 20/2054% 32%14% Binocular J3 and 20/2084%90%75%68% Maintain refractive effect--90%--76% 65% of hyperopes received 32 spots (vs. 8% of emmetropes), remainder recieved 24 spots

Spectacle / Contact Lens Dependence Original Questionnaire Responses In the treated eye: Month 6 Month 12 Wear spectacles / CL for near?44%55% Computer17%19% Reading40%55% All near activities15%16% Wear spectacles / CL for distance? (driving at night, television/movies, sports, all) ≤3%

Induced Change in Cylinder Month 6Month 12 ≥ 1 D11%9% Absolute Magnitude of Cylinder baselineMonth 6Month 12 > 0.75D0%29%21%

FDA Questions for Panel Discussion 1.Is the length of follow-up sufficient to demonstrate reasonable assurance of safety and effectiveness for the proposed indication? 2.Is the magnitude of induced cylinder and axis shift, and the associated effect on UCVA, clinically acceptable for the proposed indication? 3.Is the rate of undercorrection >1D clinically acceptable? Are there subgroups of the PMA cohort for which this outcome is not acceptable? 4.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… a.for eyes treated with the 32-spot pattern? b.for subjects >55 years of age? c.for hyperopic patients? d.for other populations or magnitude of refractive correction? 5.Do the spectacle dependence rates for near activities support approval for the requested indication in a presbyopic population? 6.Do the safety and efficacy data support approval for the requested indication? If not, what indication does the data support? 7.Do you have additional labeling recommendations, descriptive text or data? Should additional data tables be added to the physician and/or patient labeling?