Regulatory

The US Food and Drug Administration (FDA) grants Gene Signal Orphan Drug designation on Corneal Graft Rejection:

On November 7, 2016, the US Food and Drug Administration granted aganirsen an Orphan Drug Designation for Prevention of Corneal Graft Rejection.

Positive pre-IND Meeting with the US Food and Drug Administration (FDA)

Gene Signal is pleased to report the positive outcome of Pre-IND Meeting with the US Food and Drug Administration (FDA).

The purpose of this meeting was to present the current data on aganirsen 0.86 mg/mL eye drops and to confirm that the design of the pivotal trial agreed upon with the European Medicines Agency earlier this year would be acceptable to the FDA.

Following the positive feedback from the FDA, Gene Signal will finalize the protocol of the pivotal trial that will meet both the US and the EU Regulatory Authorities’ recommendations.

Positive Scientific Advice Meeting at European Medicines Agency (EMA)

Gene Signal is pleased to report the positive outcome of a Follow-up Scientific Advice with European Medicines Agency (EMA).

The purpose of this meeting was to discuss the design of the upcoming Phase III pivotal trial of aganirsen 0.86 mg/mL eye drops in a corneal indication.

During this meeting, Gene Signal has agreed with the Agency on a trial that will demonstrate the efficacy and safety of aganirsen using a scientifically and clinically meaningful endpoint, and within a reasonable timeframe.

The European Medicines Evaluation Agency (EMA) grants Orphan Drug Designation to Aganirsen (GS-101) for the treatment of Central Retinal Vein Occlusion

On 11 June 2014, Orphan designation (EU/3/14/1275) was granted by the European Commission to Gene Signal for aganirsen (GS-101) for the treatment of Central Retinal Vein Occlusion, the most common cause of Neovascular Glaucoma. 

According to Regulation EC No 141/2000, the Committee for Orphan Medicinal Products (COMP) adopted on 6 May 2014 a positive opinion recommending the grant of the above-mentioned designation.  

View EMA decision >>

In its latest Drug Information Bulletin, the World Health Organization has published a new Proposed International Non-proprietary Name for Gene Signal’s GS-101 Antisense Oligonucleotide: Aganirsen. (WHO Drug Information, Vol. 23, No. 2, 2009)

View Drug Information Bulletin >>

The European Medicines Evaluation Agency’s (EMA) 
grants Gene Signal Orphan Drug designation on Corneal Graft Rejection : 

On 17 April 2007, Orphan designation (EU/3/07/445) was granted by the European Commission to Gene Signal for GS-101 for the prevention of Corneal Graft Rejection (Doc. Ref.: EMEA/COMP/108186/2007, 30th November 2007)

According to Regulation (EC No 141/2000 of 16 December 1999), the Committee for Orphan Medicinal Products (COMP) adopted on 8 March 2007 a positive opinion recommending the grant of the above-mentioned designation.

View EMEA Website >> 

The European Medicines Evaluation Agency (EMA) grants Orphan Drug Designation to Antisense oligonucleotide (TATCCGGAGGGCTCGCCATGCTGCT) for the treatment of Neovascular Glaucoma 

On 2 October 2003, Orphan designation (EU/3/03/161) was granted by the European Commission to Gene Signal for Antisense oligonucleotide (TATCCGGAGGGCTCGCCATGCTGCT) for the treatment of Neovascular Glaucoma. 

According to Regulation EC No 141/2000, the Committee for Orphan Medicinal Products (COMP) adopted on 30 July 2003 a positive opinion recommending the grant of the above-mentioned designation. 

View EMEA Website >> 

The European Medicines Evaluation Agency (EMA) grants Orphan Drug Designation to Antisense oligonucleotide (TATCCGGAGGGCTCGCCATGCTGCT) for the treatment of retinopathy of prematurity 

On 2 October 2003, Orphan designation (EU/3/03/160) was granted by the European Commission to Gene Signal for Antisense oligonucleotide (TATCCGGAGGGCTCGCCATGCTGCT) for the treatment of retinopathy of prematurity. 

According to Regulation EC No 141/2000, the Committee for Orphan Medicinal Products (COMP) adopted on 30 July 2003 a positive opinion recommending the grant of the above-mentioned designation. 

View EMEA Website >>