Eyeworld

FEBRUARY 2025 | EYEWORLD BONUS ISSUE | 21 G IOL delivered at the time of cataract surgery, showed a mean 43.7% reduction in IOP at month 18 from baseline, and all patients re- mained off topical IOP-lowering drops at this timepoint. All patients achieved a 20% IOP reduction or more from baseline, and most (96%) maintained an IOP of 18 mm Hg or less through the study. • PolyActiva is developing the Latanoprost FA SR Ocular Implant, which completed its 48- week Phase 2 clinical trials. During the trials, patients received the first implant at week 0 and a second at week 21; safety and efficacy endpoints were met, according to data pre- sented in October 2024. This implant is fully biodegradable by 4–6 weeks. • Envisia Therapeutics is developing a travo- prost XR sustained release implant (ENV515), which in data reported in 2017 from Phase 2 trials was found to be well tolerated over 11 months. Both the low dose and the high dose demonstrated sustained IOP lowering, with the high dose showing a greater treatment effect. • Glaukos also has next-generation iDose candidates in the pipeline (iDose TREX and iDose Next Generation), as well as another transdermal sustained-release pharmaceutical Dr. Williamson doesn't yet do a combined MIGS/sustained-release implant procedure but rather waits to see how the patient does after the MIGS. "Let's say I'm going to place some iStent infinites [Glaukos]; we can see how they do, maybe they went from three drops to two drops or two drops to one drop, and I'm just wanting to get those last few IOP points to get them to a dropless situation, maybe then I would go back and place the iDose TR," he said. In the pipeline There are several companies still developing sustained-release IOP-lowering therapies at vari- ous stages (this is not an exhaustive list): • PAXTRAVA (OTX-TIC, Ocular Therapeutix) is an implant of "travoprost-loaded microparti- cles embedded in ELUTYX," a "bioresorbable, programmable hydrogel matrix that encapsu- lates drug to provide sustained and localized delivery," according to the company's website. Positive data from its Phase 2 clinical trial was reported in April 2024. • LL-BMT1, a preservative-free, proprietary drug-eluting contact lens, is being developed by MediPrint Ophthalmics. In November 2024, the company announced it had com- pleted a Phase 2b Group 1 (low dose) study. Interim analysis showed an about 5.5 mm Hg IOP reduction, with a 14%, 18%, and 19% reduction in IOP each of the 3 weeks, respec- tively, of the study, according to the compa- ny's press release. • Mati Therapeutics is developing Evolute, a latanoprost-eluting punctal plug, for multiple ophthalmic conditions, including glaucoma for which it has completed Phase 2 clinical trials. • In 2025, Amorphex Therapeutics expects to submit an investigational new drug applica- tion and begin Phase 2 studies and complete pre-clinical trials for its sustained release prostaglandin and prostaglandin-timolol combination, respectively. The mode of drug delivery being developed is TODDD, which the company describes as a "soft, patented device" worn under the patient's eyelid. • Interim analysis presented in October 2024 of a Phase 1/2 study from SpyGlass Pharma, which is developing a bimatoprost-eluting continued on page 22 Dr. Williamson implants the first iDose TR in Louisiana. Source: Blake Williamson, MD

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