ForSight Vision5’s Helios implant delivers at 6 months in Phase II trial

The Helios drug-eluting implant developed by ForSight Vision5 lowered intraocular pressure in glaucoma patients by about 20% after 6 months, according to study results published today in Ophthalmology, the journal of the American Academy of Ophthalmology.

The Helios device is a thin, silicone ring impregnated with the glaucoma drug bimatoprost that’s designed to slowly release the drug for 6 months. The aim is to overcome the compliance issue that dogs patient-administered eye drops.

The 130-patient Phase II trial compared 64 patients implanted with the Helios ring with a control arm of 66 patients implanted with a placebo ring who used 0.5% timolol drops twice a day.

Eye pressure in the Helios group fell by 3.2mmHg to 6.4mmHg at 6 months, compared with a decline of 4.2mmHG to 6.4mmHG mmHG for the control arm. Both groups showed a retention rate of 89%; the ring became dislodged in 15 patients but was replaced each time.

“In making effective treatments easier for patients, the hope is that we can reduce vision loss from glaucoma, and possibly other diseases,” lead author Dr. James Brandt, of the UC Davis Medical Center, said in prepared remarks. “What is exciting is that this is just 1 of several sustained-release drug delivery methods designed to help patients who have trouble taking daily eye drops.”

A larger, Phase III study of Helios is slated to begin later this year, according to the AAO.

ForSight Vision5 is a spinout of ForSight Labs, a Menlo Park, Calif.-based incubator focused on developing ophthalmic treatments. Last year the company added an $8 million funding round to its coffers, on top of a $15 million Series C round in 2014.

The tapped medtech veteran John Maroney as CEO in 2013 after closing on a Series B1 round worth $9.3 million.

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