The company is addressing non-adherence to eyedrops in glaucoma and in ocular hypertension. There remains a true, unmet need to provide clinically relevant intraocular pressure (IOP) reduction with a simple non-invasive product for patients who do not or cannot take their medications. ForSIGHT has developed Helios, a soft, preservative-free ring infused with bimataprost that is dispensed by the physician in a simple in-office procedure and can deliver a prostaglandin for six months.
Phase I and II studies with more than 300 subjects noted patients found Helios, which rests under the eyelid, to be comfortable and well-retained, with 90% of patients being comfortable wearing a non-medicated ring and approximately 90% retaining rings in both eyes for the six months’ duration. Two completed Phase II studies “demonstrated an excellent safety profile”; Phase III studies are expected to begin in 2016, with a New Drug Application submission expected in early 2019.
An open-label Phase I study (n = 27) found a mean IOP at screening of 16.3 mm Hg when titrated to one medication; after washout IOPs rose to 24 mm Hg. After a single placement of the ring in each eye, diurnal IOP control was maintained at about 18 to 19 mm Hg, with a range of IOP reduction between 4.7 and 6.5 mm Hg.
The company has completed seven clinical studies to date, including two double-masked, randomized Phase II efficacy studies (with ongoing safety extensions). In the first Phase II study, 130 patients were randomized to Helios and artificial tears or to placebo ring and timolol drops twice daily. There was a sustained IOP lowering from a single bimataprost ring for six months and about 90% of subjects had unassisted bilateral retention of the rings for the full six months. Similarly, about 90% of subjects found the rings to be comfortable. Overall, the safety data look excellent and consistent with the earlier data.
The second Phase II study, a dose ranging trial, has recently been completed and final data are expected by year-end. A Phase III study is expected to begin in 2016.
Internal data show 85% of patients would recommend the product to those with adherence challenges, and more than 80% of ophthalmologists prefer the concept because of the high adherence rate.
ForSIGHT Vision5 expects to begin evaluating the combination of bimatoprost and timolol in its Helios design in early 2016. It is also evaluating the ring for use in allergy and dry eye.
Anne Brody Rubin
Anne started with ForSight VISION5 as its Entrepreneur-in-Residence. Previously, she was a consultant to several start-up medical device and diagnostics companies, including ForSight VISION4.