US FDA Requires RegeneRx to Conduct Third Phase III Trial for Dry Eye Candidate RGN-259

April 13, 2018: By Jon Swedien

The US FDA will require a third Phase III clinical trial for RegeneRx Biopharmaceuticals’ dry eye candidate before the agency will consider approving its new drug application, the Rockville, Maryland, company reported April 9.

The additional Phase III trial is needed for RGN-259 to further demonstrate efficacy in both signs and symptoms of dry eye in a larger patient population, RegeneRx said.

RegeneRx licensed the US rights to RGN-259 to ReGenTree—a joint venture between GtreeBNT and RegeneRx. RegeneRx retains full ownership of the intellectual property related to RGN-259 in the European Union.

ReGenTree plans to start a new trial, ARISE-3, this year, said President and CEO Won Yang.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

US Health Secretary Alex Azar Takes Aim at Rebates in US Senate Hearing

Beyeonics Surgical Raises $11.5 Million in Initial Funding Round

MeiraGTx Raises $75 Million in Initial Public Offering

GenSight to Pursue Approval for LHON Gene Therapy Candidate, Despite Phase III Setback

Optovue Receives FDA Clearance for AngioAnalytics, First OCT Angiography Metrics

Nexy Robotic Retinal Imaging System Receives FDA Clearance

Ocutrx Receives US Patent for Oculenz AR Glasses for Macular Degeneration

Allergan’s Bimatoprost SR Demonstrates Noninferiority to Timolol in Phase III Glaucoma Study

KKR to acquire Envision Healthcare, Including Amsurg ASC Business

Ophthalmologist Carmen Puliafito, MD, Seeks to Regain Medical License

Avedro Gains J Code for Photrexa Formulations in Preliminary CMS Decision

EyeGate Seeks to Study Ocular Bandage Gel in Punctate Epitheliopathy

Nicox, Ironwood to Collaborate on Novel Ophthalmic Treatments

US FDA Approves MDGH’s Moxidectin for Treatment of River Blindness

Bausch + Lomb Enrolls First Patient in Trial for enVista MX60EF Trifocal IOL

Cincinnati Eye Institute Partners with Private Equity Firm to Pursue National Expansion

Ophthotech Enters Gene Therapy Deals with University of Florida, University of Pennsylvania

Teva’s Launches Generic Version of Restasis in Canada

Clearside’s Phase II Trial for DME Candidate Meets Primary Endpoint

Orasis Raises $13 Million in Series B Financing

Coming soon

2018 Glaucoma Device Report: A Global Market Analysis for 2017 to 2023