ForSight VISION5's Clinical Data Demonstrating 6-Month IOP-Lowering from a Single Dose Presented at World Glaucoma Congress; Company Completes Enrollment of Phase 2 Dose-Ranging Study
MENLO PARK, Calif., June 11, 2015 /PRNewswire/ -- ForSight VISION5 recently met two key clinical milestones: completion of enrollment of 121 subjects in its Phase 2 dose-ranging study, and presentation of Phase 1b data at the World Glaucoma Congress in Hong Kong. The presented data demonstrated that a single administration of its investigational HeliosTM bimatoprost ocular insert[1] provided sustained reduction in intraocular pressure (IOP) for six months. ForSight VISION5 is developing non-invasive ophthalmic products that are designed to replace eye drops and provide sustained therapy for major eye diseases including glaucoma, dry eye, and allergy.
The Phase 1b data were collected from a multicenter, prospective, single-arm, open-label, pooled analysis of the bimatoprost ocular insert. The data were presented by Prof. Ivan Goldberg, principal investigator of the Australian study, in a poster titled "Maintenance of IOP-Reduction for 6 Months with a Single Dose of a Novel Topically Applied Bimatoprost Ocular Insert in Patients with Open-Angle Glaucoma or Ocular Hypertension." In this analysis of 27 subjects who met eligibility criteria, mean diurnal IOP at washout was 23.9 mmHg and a mean sustained diurnal IOP reduction of 4.7-6.5 mmHg was observed for 6 months. There were no reported serious or unexpected ocular adverse events.
"Demonstration of sustained IOP-lowering for six months from a single, topical, ocular insert represents a significant step towards providing therapy to the many patients with glaucoma and ocular hypertension who struggle with adherence and persistence," said Prof. Ivan Goldberg. "Nearly half of patients who are prescribed eye drops to manage their glaucoma may stop refilling their prescriptions after six months[2] - often from difficulty in using drops. The early data suggest that the investigational bimatoprost ocular insert may provide a well-tolerated and meaningful and sustained reduction in intraocular pressure in this at-risk population. It would be meaningfully helpful to have a therapeutic option to enable medical treatment for patients with these challenges."
ForSight VISION5 continues to advance the clinical development of the Helios insert. The Phase 2 dose-ranging study (FSV5-004) is a prospective, randomized, double-masked, controlled study designed to evaluate the efficacy, safety, and dose-response of two loading doses of the bimatoprost ocular insert compared to a control arm in subjects with open-angle glaucoma or ocular hypertension. The study enrolled 121 subjects at ten clinical sites in the USA in under nine weeks.
"This study will provide additional supporting clinical evidence of the sustained-release profile of the Helios insert prior to an anticipated End-of-Phase 2 meeting with the Food and Drug Administration later this year," said Charles Semba, M.D., Chief Medical Officer for ForSight VISION5. "We are appreciative of our investigators and participating patients. We expect topline data in the second half of 2015."
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 anterior segment 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.
Company Contact Information:
Anne Brody Rubin
Vice President of Marketing
ForSight VISION5
Tel: (650) 325-2050 x119
[email protected]
www.forsightvision5.com
For Investors:
Lisa Wilson
President
In-Site Communications, Inc.
Tel: (917) 543-9932
[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] Nordstrom, BL et al. "Persistence and Adherence with Topical Glaucoma Therapy" Am J Ophthalmol 2005;140:598–606.
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SOURCE ForSight VISION5
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