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Deepank Utkhede, Robert William; Improving Retention Rates for Sustained Therapeutic Delivery Through Punctal Plugs. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5675.
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Retention rates for commercially available punctal plug have been regarded as too low for use in the development of sustained release treatments for chronic conditions such as glaucoma. Mati Therapeutics initiated development for a punctal plug with a retention rates in excess of 90% in the lower puncta to address the shortcomings of currently available punctal plugs.
Two prospective phase II studies were completed to evaluate the retention rates and comfort on the newly designed punctal plug. Subjects diagnosed with bilateral OH or OAG were eligible. Successful plug insertion at Day 0 was required for study enrollment. After eligibility was established, subjects were followed for 12 weeks. Subjects were assessed for safety and monitored for multiple factors including adverse events (AEs), IOP, Snellen best-corrected visual acuity (BCVA), and subject tearing and comfort. Tearing and comfort was assessed on a visual analog scale by asking subjects to rate their level of comfort in each eye from 0 (completely acceptable) to 100 (completely unacceptable) and amount of tearing from 0 (Never) to 100 (All the time).
1st phase II trial - 70 eyes completed the 12 week trial with an overall punctal plug retention rate of 96%. Tearing and comfort changes were minimal with a tearing score at baseline of 25 which increased to approximately 35 on day one after insertion of the Evolute® and then returned to baseline or below by week 2. Comfort scores at baseline were 25, which increased to approximately 35 on day one following insertion of the Evolute® and returned to baseline or below by week 2. In the 2nd phase II trial – 64 eyes completed the 12-week trial at multiple U. S. centers. Retention rate of plugs was 92% at Week 12. Tearing scores at baseline were similar to the previous trial with scale scores of approximately 23 with a minimal increase to approximately 37 at day one after insertion and then returning to baseline. Comfort scores at baseline were marginally lower than the previous trial at approximately 20, which increased to approximately 30 on day one after insertion and then returned to baseline.
Our results from two well controlled phase II trials demonstrate that the newly designed Evolute® Punctal Plug delivers retention rates in excess of 90%. Patient tearing and comfort scores were mild at all time points and showed no difference from baseline at longer time points.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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