Clinical Safety and Efficacy Data

Ninety percent of IMT-implanted eyes achieved at least a 2-line or greater gain in either distance or near BCVA at 12 months, thus exceeding the 50% criterion specified for the primary endpoint. This criterion was also exceeded at 24 months.

At least 50% of IMT-implanted eyes were required to improve ≥ 2 lines of best-corrected distance or near visual acuity (BCDVA or BCNVA). In the study, 90.1% of patients achieved this level of improvement.

Long-term follow up data from the IMT-002-LTM study demonstrated mean BCDVA improvements were generally retained at 36 and 48 months in telescope-implanted eyes. Mean BCDVA was maintained between 12 and 48 months, with BCDVA at 48 months within 2 line of BCDVA at 12 months.

Clinically meaningful visual acuity benefit demonstrated through 2-year follow up. 60% of patients gained better than 3 lines of best-corrected distance visual acuity (BCVA).

Quality of life, as assessed by the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25), was a secondary outcome measure. The VFQ-25 is a validated version of the National Eye Institute Visual Functioning Questionnaire (VFQ) which measures vision-targeted health status for persons with chronic eye diseases including macular degeneration. A 5-point difference in subscale and/or composite scores may be interpreted as clinically significant.^(3-5) The VFQ-25 survey was administered at baseline and postoperatively. The results demonstrate that implantation with the IMT improved quality of life in this study population (subjects with End-Stage AMD and significant bilateral vision impairment). The mean overall composite score, as well as the scores for almost all relevant subscales, achieved a clinically significant level. Not only was there an improvement in vision-specific subscales, which would be expected with a doubling of visual acuity, there was also a significant improvement on the psychosocial vision-targeted dependency, mental health, role difficulties, and social functioning subscales. Results suggest that patients are less dependent on others, less worried or frustrated with their visual acuity, less limited in their activities related to visual acuity, more able to visit with others, and better able to recognize facial expressions.⁽¹⁾

A total of 217 subjects were evaluated in the IMT-002 clinical trial. A total of 206 eyes were implanted with the telescope prosthesis and followed for 24 months. 129 patients were enrolled in the IMT-002-LTM long-term monitoring trial for which 4-year safety data was available.

Ocular complications encountered during the studies included endothelial cell loss, inflammatory/pigment deposits, transient cornea edema, and IOP elevation.