Orphan Drug Designation Expanded for Mobius Therapeutics’ Mitosol

November 3, 2017: By Jon Swedien

download (1)

Mobius Therapeutics announced Oct. 31 that the orphan drug designation for Mitosol has been changed to read: “treatment of refractory glaucoma as an adjunct to surgery.”

Mitosol is an ophthalmic reformulation of mitomycin C for use in glaucoma surgery. The new designation lays the groundwork for Mobius to pursue an expanded indication for Mitosol that would include refractory glaucoma surgery.

The new designation qualifies Mobius for a research and development tax credit and a waiver of its prescription drug user fee when it seeks an expanded designation, said Ed Timm, president of Mobius.

Ultimately, Mobius would like to pursue an expanded indication for Mitosol that would cover ab interno glaucoma surgery, Timm said. Ab interno glaucoma surgery includes minimally invasive glaucoma surgeries (MIGS). Mitosol is currently indicated as an adjunct to ab externo glaucoma surgery.

“New MIGS procedures, typified by the XEN Gel Stent, have relied upon Mitosol as a companion drug during pivotal clinical trials,” Timm said.

InnFocus, now part of Santen, has also used Mitosol in clinical trials for its MicroShunt MIGS device, Timm said.

St. Louis-based Mobius is a commercial stage venture focused upon perioperative sterile injectables used in ophthalmic surgery.

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

Ellex Raises $17.7 Million in Private Placement

Genentech’s Lampalizumab Fails Second Phase III Study in Geographic Atrophy

Judge Declares Mistrial in Corruption Trial of Melgen, Menendez

Imprimis’ Q3-2017 Ophthalmic Revenues Increase 60 Percent, Total $4.9 Million

iVeena Completes Phase I/IIa Study of IVMED-10 for Post-Cataract Inflammation

RegeneRx Announces Positive Phase III Results for RGN-259 in Dry Eye

Bill Link, PhD, Joins LENSAR as Board Chairman

Apellis Prices $150 Million Initial Public Offering

Oculentis Recalls Lentis IOLs in Philippines Due to Reports of Postoperative Opacification

Valeant Reports 1 Percent Growth for Bausch + Lomb Segment in Q3-2017

Tivanisiran is Generic Name for Sylentis’ Dry Eye Candidate

Alimera’s Q3-2017 Revenues Increased 18 Percent; Company Sees Expanded Market for Iluvien

Iridex’ Revenues Increase 11 Percent in Q3-2017; 111 Cyclo G6 Systems, 7,800 G6 Probes Shipped

Glaukos’ Net Sales Increase 37 Percent in Q3-2017

Regeneron’s US Eylea Sales Increase 12 Percent in Q3-2017

Second Sight Reports Q3-2017 Net Sales of $1.6 Million, New $122,500 CMS Rate for Argus II

Tear Film Innovations, Exicure, Genisphere Complete Financing Rounds

Opternative Sues Warby Parker Over Online Eye Exams

Bausch + Lomb Receives US FDA Approval for Vyzulta for IOP Reduction in Glaucoma Patients

Allergan Plans Cost Cuts, Takes Impairment Charge as Restasis Generics Loom

Coming soon

2017 Dry Eye Products Report: A Global Market Analysis for 2016 to 2022