MENLO PARK, Calif, and LAS VEGAS, Nov. 17, 2015 /PRNewswire/ -- ForSight VISION5 announced results of its first randomized, controlled Phase 2 study comparing the investigational HeliosTM bimatoprost ocular insert1 to twice-daily timolol eye drops. The presented data demonstrated that a single administration of the investigational HeliosTM bimatoprost ocular insert provided sustained reduction in intraocular pressure (IOP) for six months and IOP reduction of 4-6 mmHg at the study's primary endpoint of 12 weeks. Approximately 90% of subjects retained inserts in both eyes for 6 months without clinician assistance. The HeliosTM preservative-free bimatoprost ocular insert is designed to provide sustained IOP-lowering for patients who cannot or do not take their prescribed eye drops. IOP-lowering has been shown to reduce visual field loss in patients with ocular hypertension and open-angle glaucoma.2
The Phase 2 results comprise data from 130 subjects and were collected from ten clinical sites in the Unites States in a randomized, double-masked, active-controlled trial of the bimatoprost ocular insert compared to twice-daily timolol eye drops. To achieve masking, subjects in the bimatoprost insert arm used concomitant unpreserved artificial tears and subjects in the timolol eye drop arm used concomitant non-medicated ocular inserts. The data were presented today by Prof. James D. Brandt, principal investigator of the study and Director of the Glaucoma Service at the University of California Davis Health System, at the American Academy of Ophthalmology (AAO) annual meeting.
Highlights of the clinical results include:
- Mean diurnal IOP after washout was 23.8 mmHg. A sustained reduction in IOP from a single dose of the bimatoprost insert was observed to be 4-6 mmHg across the three diurnal time points at the primary endpoint of 3 months, and clinically relevant IOP reduction continued through 6 months.
- Over the six month period, the single dose of the bimatoprost insert (OU) lowered IOP by an average of one less mmHg than the 360 drops of timolol applied to each eye in the other arm of the study. This amount of IOP-lowering is considered to be clinically relevant since the product candidate is designed to address the needs of patients who are nonadherent to their eye drops.
- The primary efficacy endpoints consisted of comparisons of the bimatoprost insert arm to the timolol drops arm at each of three diurnal time points (T=0, 2, 8 hours) at each of Weeks 2, 6, and 12 of treatment. Secondary endpoints consisted of the same diurnal time point comparisons at Months 4, 5, and 6. While the confidence intervals in this limited study did not meet the test for statistical non-inferiority to timolol, the results suggest that a larger-scale Phase 3 study could achieve data that would be appropriate for registration with the FDA.
- Subjects found the inserts comfortable with approximately 90% of subjects experiencing acceptable comfort of a non-medicated insert during the washout phase of the study.
- 88.5% of subjects retained the inserts in both eyes for 6 months without the aid of a clinician, and in all cases in which an insert was dislodged, the subject was aware of dislodgement.
- There were no reported serious or unexpected ocular adverse events in the bimatoprost insert group. The most frequent treatment-emergent adverse events in the bimatoprost insert group (≥5% of subjects) were eye discharge (16%), conjunctival hyperemia (14%), punctate keratitis (13%), eye pruritis (11%), and ocular discomfort (6%) and were mostly transient.
"We know that a significant portion of our patients struggle with IOP-lowering eye drop adherence and persistence and that inadequate eye drop usage leads to vision loss," said Brandt. "A well-tolerated, well-retained, topical sustained drug delivery system that provides clinically relevant IOP-lowering for six months would allow us to treat these patients in a meaningful way."
ForSight VISION5 continues to advance the clinical development of the Helios insert. The company recently also completed a Phase 2 dose-ranging study (FSV5-004) that enrolled 121 subjects at ten clinical sites in the USA in under nine weeks. The company intends to initiate a Phase 3 clinical program in 2016.
"There is tremendous unmet need for a drug delivery mechanism that can deliver therapeutic levels of IOP lowering medication without requiring penetration of ocular tissue such as the sclera, cornea or conjunctiva in patients with glaucoma and ocular hypertension" said Dr. Kuldev Singh, Professor of Ophthalmology and Director of the Glaucoma Service at Stanford University School of Medicine. "In addition to addressing the enormous problem of poor adherence to glaucoma medications, a drug delivery approach that encourages patients to return every few months for treatment may also improve disease surveillance allowing for appropriate adjustment of therapy," added Singh who cited recent work with collaborators from the University of California San Francisco which suggest that poor follow up may be an independent risk factor for glaucoma progression.3
The company is also pleased that the safety and retention data from the study presented today further validate the ForSight VISION5 ocular insert as a potential delivery system for other ophthalmic drugs to treat a variety of additional indications.
About ForSight VISION5, Inc.
ForSight VISION5, Inc. was founded in January of 2011 as the fifth company to emerge from the ophthalmic incubator ForSight Labs, LLC. ForSight VISION5 is focused on developing non-invasive drug delivery products that replace eye drops and provide sustained therapy for major eye diseases including glaucoma, dry eye, and allergy. ForSight VISION5's lead product candidate is the Helios insert, a novel, non-invasive delivery system designed to allow glaucoma and ocular hypertensive patients to receive medication continually. ForSight VISION5's investors include Versant Ventures, Morgenthaler Ventures, Technology Partners, Delphi Ventures, and H.I.G. BioVentures. For more information, please visit www.forsightvision5.com.
1 The Helios insert is restricted to investigational use only and has not been approved by the Food and Drug Administration or any other regulatory authority for commercial distribution.
2 Sleath B, et al. The relationship between glaucoma medication adherence, eye drop technique, and visual field defect severity. Ophthalmology 2011; 118:2398-2402.
3 Ung C, Murakami Y, Zhang E, Alfaro T, Zhang M, Seider MI, Singh K, Lin SC. The association between compliance with recommended follow-up and glaucomatous disease severity in a county hospital population. Am J Ophthalmol. 2013 Aug;156(2):362-9
SOURCE ForSight VISION5