Progressing innovative development pipeline with 4 compounds targeting novel treatments for diabetic eye disease
OASIS Phase IIIb 2 year follow up study confirms long term safety and efficacy of ocriplasmin - publication in Ophthalmology AAO Journal
Highlights
• ThromboGenics progressing attractive portfolio of novel medicines for the treatment of diabetic eye disease: 4 compounds targeting novel treatments for diabetic retinopathy (DR) - non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR), in the presence or absence of diabetic macular edema (DME)
• ThromboGenics is conducting a Phase IIa clinical study (CIRCLE) evaluating THR-409 (ocriplasmin) to induce a complete posterior vitreous detachment (PVD), to prevent patients with non-proliferative diabetic retinopathy (NPDR) from progressing to proliferative diabetic retinopathy (PDR), a serious sight threatening condition
• ThromboGenics signed a global and exclusive license agreement with Galapagos to develop and commercialize integrin antagonists for the treatment of diabetic eye disease. The Company has started to explore the potential of these compounds, including THR-687, for the treatment of NPDR and PDR
• ThromboGenics is developing THR-317, an anti-PlGF inhibitor, for the treatment of DME which is on track to enter the clinic by end of 2016.
• Oncurious has started a Phase I/IIa study evaluating TB-403 in children with medulloblastoma in May
• In H1 2016, ThromboGenics reported overall revenues of €4.0 million from JETREA®, including €1.4 million in royalty income from its partner Alcon (Novartis)
• Positive data of OASIS 2 year Phase IIIb study evaluating JETREA® (ocriplasmin) for the treatment of Symptomatic VMA/VMT and Macular Hole (n=220) has been published in Ophthalmology, Journal of the American Academy of Ophthalmology.
• Cash and investments were €91.5 million as of the end of June 2016. This compares to €101.4 million on December 31, 2015.
Leuven, Belgium – 25 August 2016 - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines for diabetic eye disease, today issues a business update for the six month period ending 30 June, 2016.
ThromboGenics is developing novel medicines for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME).
ThromboGenics is developing an attractive pipeline of disease modifying drug candidates for diabetic eye disease. The pipeline consists of THR-409, THR-317, both from the Company’s in-house research, as well as THR-149 which resulted from a research collaboration with Bicycle Therapeutics, and THR-687, which was in-licensed from Galapagos NV in March 2016.
These products all have different modes of action and will allow the Company to address the four key segments of the rapidly growing diabetic eye disease market:
• Non-proliferative DR • Proliferative DR • Non-proliferative DR with DME • Proliferative DR with DME
Dr. Patrik De Haes, ThromboGenics’ CEO, said: “ThromboGenics is progressing its exciting drug development pipeline of potential new disease modifying medicines for the treatment of diabetic eye disease. Diabetic Retinopathy and Diabetic Macular Edema are significant indications where there are clear unmet medical needs and a strong demand for improved or add-on treatment options. With our innovative pipeline, we believe we can address all key segments of the diabetic eye disease market and generate attractive returns for our shareholders.”
Research & Development Activities
Diabetes, Diabetic Retinopathy and Diabetic Macular Edema
Diabetes is a major global healthcare problem with 9% of adults (18 years and older) suffering from this disease[1].
Diabetic retinopathy (DR) is the leading cause of visual disability and blindness among professionally active adults[2]. More than one in three living with diabetes (35.4%) will develop some form of DR in their lifetime. One in five patients with DR presents with DME.
DR progresses from mild, non-proliferative to more severe or even proliferative stages. As DR progresses, there is a gradual closure of retinal blood vessels leading to impaired perfusion and ischemia of the retina. When this progresses beyond certain thresholds, severe non-proliferative diabetic retinopathy (NPDR) is diagnosed.
The more advanced stage of DR, Proliferative DR (PDR), is characterized by the development of new blood vessels at the inner surface of the retina as a result of retinal ischemia. These new vessels are prone to bleed, resulting in vitreous hemorrhage. These new vessels may also undergo fibrosis and contraction, which may lead to epiretinal membrane formation, vitreoretinal traction bands, retinal tears and traction or retinal detachments.
PDR is considered high risk when the new vessels are accompanied by vitreous hemorrhage, or when they cover a significant area of the optic disc.
Patients who progress to PDR are at high risk of severe vision loss.
Innovative Pipeline of Novel Medicines Targeting Diabetic Eye Disease such as Diabetic Retinopathy and Diabetic Macular Edema
ThromboGenics development pipeline is comprised of:
• THR-409 (ocriplasmin) – is in a Phase IIa (CIRCLE) clinical study evaluating the efficacy and safety of multiple doses and/or half-doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). The Phase IIa study was initiated in early 2016.
• THR-317 – a PlGF inhibitor being developed for DME and potentially as a combination therapy for current anti-VEGF treatments. THR-317 is expected to enter the clinic by end of 2016.
• THR-149 – a selective plasma kallikrein inhibitor being developed to treat the edema associated with DR. This compound is the result of the Company’s research collaboration with Bicycle Therapeutics. THR-149 is expected to enter the clinic by late 2017.
• THR-687 – an integrin antagonist being developed to treat a broad range of patients with DR, with or without DME. THR-687 was in-licensed from Galapagos NV in March.
On March 18, 2016, ThromboGenics hosted a R&D investor meeting in London presenting more detailed information on its new development pipeline in diabetic eye disease.
The webcast replay of the event is available on the ThromboGenics’ website.
THR-409 for Non Proliferative Diabetic Retinopathy
In January 2016, the Company announced the initiation of its Phase IIa (CIRCLE) study.
The CIRCLE study is evaluating the efficacy and safety of multiple doses of THR-409 (ocriplasmin) in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). Research has suggested that total PVD, a complete separation of vitreous and retina, prevents the progression of NPDR to PDR. This could be explained by total PVD leading to elimination of the scaffold needed for the development of new blood vessels and/or the improvement of oxygen supply to the retina, thereby reducing retinal ischemia, production of VEGF, vascular outgrowth and neovascularization. ThromboGenics believes that by using multiple doses of THR-409 it can reduce the risk of patients’ disease progressing from NPDR to PDR by inducing a total PVD. Patients who progress to PDR are at high risk of experiencing severe vision loss or complete blindness. The CIRCLE study is a Phase II, randomized, double-masked, sham-controlled, multi-center study that will evaluate the efficacy and safety of up to 3 intravitreal injections of either 0.125mg or half of the approved dose (0.0625mg) of THR-409 in subjects with moderately severe to very severe NPDR, to induce total PVD and reduce the risk of the patient progressing to sight-threatening PDR.
The primary endpoint of the CIRCLE study is the percentage of patients with total PVD at the time of their visit one month after the 3rd injection, as confirmed by both B-scan ultrasound and SD-OCT.
The study has a number of secondary endpoints that are designed to provide further insights into ocriplasmin’s potential in reducing the risk of progression of NPDR to PDR.
THR-317 – anti PIGF antibody to treat Diabetic Macular Edema
THR-317 is a disease modifying, anti PlGF antibody that has the potential to treat a broad range of patients with late stage diabetic eye disease either alone or in combination with anti-VEGF treatments. ThromboGenics is currently developing THR-317 for the treatment of diabetic macular edema and expects to start the clinical development of this novel antibody towards the end of 2016.
The planned Phase I/II study expects to recruit 50 patients, either anti-VEGF naïve patients or anti-VEGF poor responders. The trial will have two arms comparing a low dose of THR-317 with a high dose of THR-317. The trial will assess the safety of THR-317 and will look at best corrected visual acuity and retinal thickness to evaluate the product’s efficacy.
Oncurious NV – Developing TB-403 for Pediatric Brain Cancers
Oncurious is developing TB-403 for the treatment of pediatric tumors.
TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival. Medulloblastoma is the most common pediatric malignant brain tumor, accounting for 20% of all brain tumors in children.
Treatment with TB-403 in relevant animal models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival. The favorable safety profile of TB-403 has already been demonstrated in clinical trials in patients with other diseases.
In March 2016, Oncurious and its development partner BioInvent International signed a partnership agreement with the Neuroblastoma and Medulloblastoma Translational Research Center (NMTRC) to accelerate the clinical development of TB-403 for the treatment of medulloblastoma in the US. The NMTRC is a non-profit organization with the mission to bring forward new effective therapies against neuroblastoma and medulloblastoma. Headquartered at Helen DeVos Children’s Hospital in Grand Rapids, MI, NMTRC is a network of 18 leading university hospitals and pediatric clinics in the US.
In May, Oncurious and BioInvent announced that they had initiated a Phase I/IIa study with TB-403. The study, which is being conducted by NMTRC, aims to recruit 27 patients with Relapsed or Refractory Medulloblastoma.
JETREA Update
JETREA® Regulatory & Markets Access
ThromboGenics’ first commercial drug JETREA® is now approved in 54 countries and reimbursed in over 20 countries.
Globally, around 25,000 patients have received a treatment with JETREA®.
The successful development of JETREA® demonstrates ThromboGenics pioneering role in developing pharmacological vitreolysis as a new drug class and treatment option for symptomatic vitreomacular adhesion or vitreomacular traction.
Further JETREA® submissions, approvals and country launches are anticipated in the remainder of 2016.
US FDA Approval for New ‘Already-Diluted’ Formulation of JETREA®
In June, ThromboGenics announced that the Office of Biotechnology Products of the U.S. Food and Drug Administration (FDA) had approved a new already-diluted formulation of JETREA® (ocriplasmin). The new formulation of JETREA® offers the additional benefit of eliminating the current preparatory dilution steps prior to injection.
ThromboGenics Inc., which is commercializing JETREA® in the US, plans to launch the already-diluted formulation of JETREA® in the first half of 2017.
Ocriplasmin Research Findings Presented at ARVO
New JETREA® research findings were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2016 annual meeting in Seattle at the beginning of May.
15 ocriplasmin-related presentations, abstracts and posters were delivered at ARVO. These covered preclinical research findings, real-world clinical data, and further characterization of results from different studies, including OASIS, ORBIT, and OVIID conducted in the US and Europe.
The data update confirmed the product’s safety profile as described in the approved product label, with no new safety signals. Moreover, these new clinical studies and real-world data continued to confirm that appropriate patient selection leads to improved treatment outcomes.
Ocriplasmin ORBIT and OASIS Data Presented at ASRS, San Francisco
Ocriplasmin clinical data were presented during the 34th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) which took place from August 9 to 14 in San Francisco.
During this premier educational retina meeting, Dr Mathew MacCumber presented “ORBIT, A Phase IV Clinical Study: Lessons Learned From Patient Selection Criteria for Ocriplasmin Intravitreal Injection”.
In addition, Dr Joseph Coney presented “data from the OASIS Trial: Natural History of Symptomatic Vitreomacular Adhesion”.
Dr Michael Tolentino presented “Efficacy and Safety Outcomes in Subjects with Full-Thickness Macular Hole”, also from the OASIS trial.
Ocriplasmin OASIS Phase III b 2 Year Follow- Up Study Published in Ophthalmology, AAO Journal
The full report of the 2 year follow up of the OASIS study evaluating JETREA® (ocriplasmin) for the treatment of Symptomatic VMA/VMT and Macular Hole (n=220) has been published in Ophthalmology, Journal of the American Academy of Ophthalmology.
OASIS was designed to provide long term controlled efficacy and safety data for JETREA® in patients being treated for symptomatic vitreomacular adhesion (sVMA). The study included 24 months follow up data the longest period patients have been studied post treatment with this novel medicine.
In its overall conclusion, Ophthalmology confirms 'the OASIS data demonstrates the long-term efficacy and safety of ocriplasmin, providing improved resolution of symptomatic VMA compared with previous phase 3 trials, with no additional safety signals identified'.
The article ‘Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial’ can be consulted online here.
OASIS data, and its positive conclusions, will be shared further through presentations and publications which may be expected prior to and during the upcoming AAO meeting in Chicago, (Oct 15 -18, 2016).
Financial review
In the first half of 2016, ThromboGenics had total revenues of €4.0 million, including €2.4 million of JETREA® sales in the US, €1.4 million in royalties from Alcon (Novartis) based on its ex-US sales of JETREA® the remaining being miscellaneous product Sales. In the corresponding period in 2015, ThromboGenics reported a total income of €6 million.
During the first six months of 2016, the Group reported a gross profit of €2.6 million.
In the first half of 2016, ThromboGenics’ R&D expenses were €12.0 million, including a €3.4 million depreciation in intangible assets relating to ocriplasmin Phase III program. This compares with €10.3 million of R&D expenses in the same period in 2015.
In the first half of 2016, selling and marketing expenses amounted to €2.2 million compared with €10.2 million in the corresponding period in 2015. The cost reduction is due to the full effect of the reduction in size of our US organization which took place in 2015. ThromboGenics Inc is now a lean customer-centric organization that is continuing to support JETREA® via a well-established distribution network.
For the first half of 2016, ThromboGenics reported a net loss of €15.0 million, or €0.42 per share. In the corresponding period in 2015 the Company reported a net loss of €19.2 million or €0.53 per share.
At the end of June 2016, ThromboGenics had €91.5 million in cash and investments. This compares to €101.4 million on December 31, 2015.
OASIS Phase IIIb 2 year follow up study confirms long term safety and efficacy of ocriplasmin - publication in Ophthalmology AAO Journal
Highlights
• ThromboGenics progressing attractive portfolio of novel medicines for the treatment of diabetic eye disease: 4 compounds targeting novel treatments for diabetic retinopathy (DR) - non-proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR), in the presence or absence of diabetic macular edema (DME)
• ThromboGenics is conducting a Phase IIa clinical study (CIRCLE) evaluating THR-409 (ocriplasmin) to induce a complete posterior vitreous detachment (PVD), to prevent patients with non-proliferative diabetic retinopathy (NPDR) from progressing to proliferative diabetic retinopathy (PDR), a serious sight threatening condition
• ThromboGenics signed a global and exclusive license agreement with Galapagos to develop and commercialize integrin antagonists for the treatment of diabetic eye disease. The Company has started to explore the potential of these compounds, including THR-687, for the treatment of NPDR and PDR
• ThromboGenics is developing THR-317, an anti-PlGF inhibitor, for the treatment of DME which is on track to enter the clinic by end of 2016.
• Oncurious has started a Phase I/IIa study evaluating TB-403 in children with medulloblastoma in May
• In H1 2016, ThromboGenics reported overall revenues of €4.0 million from JETREA®, including €1.4 million in royalty income from its partner Alcon (Novartis)
• Positive data of OASIS 2 year Phase IIIb study evaluating JETREA® (ocriplasmin) for the treatment of Symptomatic VMA/VMT and Macular Hole (n=220) has been published in Ophthalmology, Journal of the American Academy of Ophthalmology.
• Cash and investments were €91.5 million as of the end of June 2016. This compares to €101.4 million on December 31, 2015.
Leuven, Belgium – 25 August 2016 - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines for diabetic eye disease, today issues a business update for the six month period ending 30 June, 2016.
ThromboGenics is developing novel medicines for diabetic eye disease, particularly diabetic retinopathy (DR) and diabetic macular edema (DME).
ThromboGenics is developing an attractive pipeline of disease modifying drug candidates for diabetic eye disease. The pipeline consists of THR-409, THR-317, both from the Company’s in-house research, as well as THR-149 which resulted from a research collaboration with Bicycle Therapeutics, and THR-687, which was in-licensed from Galapagos NV in March 2016.
These products all have different modes of action and will allow the Company to address the four key segments of the rapidly growing diabetic eye disease market:
• Non-proliferative DR • Proliferative DR • Non-proliferative DR with DME • Proliferative DR with DME
Dr. Patrik De Haes, ThromboGenics’ CEO, said: “ThromboGenics is progressing its exciting drug development pipeline of potential new disease modifying medicines for the treatment of diabetic eye disease. Diabetic Retinopathy and Diabetic Macular Edema are significant indications where there are clear unmet medical needs and a strong demand for improved or add-on treatment options. With our innovative pipeline, we believe we can address all key segments of the diabetic eye disease market and generate attractive returns for our shareholders.”
Research & Development Activities
Diabetes, Diabetic Retinopathy and Diabetic Macular Edema
Diabetes is a major global healthcare problem with 9% of adults (18 years and older) suffering from this disease[1].
Diabetic retinopathy (DR) is the leading cause of visual disability and blindness among professionally active adults[2]. More than one in three living with diabetes (35.4%) will develop some form of DR in their lifetime. One in five patients with DR presents with DME.
DR progresses from mild, non-proliferative to more severe or even proliferative stages. As DR progresses, there is a gradual closure of retinal blood vessels leading to impaired perfusion and ischemia of the retina. When this progresses beyond certain thresholds, severe non-proliferative diabetic retinopathy (NPDR) is diagnosed.
The more advanced stage of DR, Proliferative DR (PDR), is characterized by the development of new blood vessels at the inner surface of the retina as a result of retinal ischemia. These new vessels are prone to bleed, resulting in vitreous hemorrhage. These new vessels may also undergo fibrosis and contraction, which may lead to epiretinal membrane formation, vitreoretinal traction bands, retinal tears and traction or retinal detachments.
PDR is considered high risk when the new vessels are accompanied by vitreous hemorrhage, or when they cover a significant area of the optic disc.
Patients who progress to PDR are at high risk of severe vision loss.
Innovative Pipeline of Novel Medicines Targeting Diabetic Eye Disease such as Diabetic Retinopathy and Diabetic Macular Edema
ThromboGenics development pipeline is comprised of:
• THR-409 (ocriplasmin) – is in a Phase IIa (CIRCLE) clinical study evaluating the efficacy and safety of multiple doses and/or half-doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). The Phase IIa study was initiated in early 2016.
• THR-317 – a PlGF inhibitor being developed for DME and potentially as a combination therapy for current anti-VEGF treatments. THR-317 is expected to enter the clinic by end of 2016.
• THR-149 – a selective plasma kallikrein inhibitor being developed to treat the edema associated with DR. This compound is the result of the Company’s research collaboration with Bicycle Therapeutics. THR-149 is expected to enter the clinic by late 2017.
• THR-687 – an integrin antagonist being developed to treat a broad range of patients with DR, with or without DME. THR-687 was in-licensed from Galapagos NV in March.
On March 18, 2016, ThromboGenics hosted a R&D investor meeting in London presenting more detailed information on its new development pipeline in diabetic eye disease.
The webcast replay of the event is available on the ThromboGenics’ website.
THR-409 for Non Proliferative Diabetic Retinopathy
In January 2016, the Company announced the initiation of its Phase IIa (CIRCLE) study.
The CIRCLE study is evaluating the efficacy and safety of multiple doses of THR-409 (ocriplasmin) in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). Research has suggested that total PVD, a complete separation of vitreous and retina, prevents the progression of NPDR to PDR. This could be explained by total PVD leading to elimination of the scaffold needed for the development of new blood vessels and/or the improvement of oxygen supply to the retina, thereby reducing retinal ischemia, production of VEGF, vascular outgrowth and neovascularization. ThromboGenics believes that by using multiple doses of THR-409 it can reduce the risk of patients’ disease progressing from NPDR to PDR by inducing a total PVD. Patients who progress to PDR are at high risk of experiencing severe vision loss or complete blindness. The CIRCLE study is a Phase II, randomized, double-masked, sham-controlled, multi-center study that will evaluate the efficacy and safety of up to 3 intravitreal injections of either 0.125mg or half of the approved dose (0.0625mg) of THR-409 in subjects with moderately severe to very severe NPDR, to induce total PVD and reduce the risk of the patient progressing to sight-threatening PDR.
The primary endpoint of the CIRCLE study is the percentage of patients with total PVD at the time of their visit one month after the 3rd injection, as confirmed by both B-scan ultrasound and SD-OCT.
The study has a number of secondary endpoints that are designed to provide further insights into ocriplasmin’s potential in reducing the risk of progression of NPDR to PDR.
THR-317 – anti PIGF antibody to treat Diabetic Macular Edema
THR-317 is a disease modifying, anti PlGF antibody that has the potential to treat a broad range of patients with late stage diabetic eye disease either alone or in combination with anti-VEGF treatments. ThromboGenics is currently developing THR-317 for the treatment of diabetic macular edema and expects to start the clinical development of this novel antibody towards the end of 2016.
The planned Phase I/II study expects to recruit 50 patients, either anti-VEGF naïve patients or anti-VEGF poor responders. The trial will have two arms comparing a low dose of THR-317 with a high dose of THR-317. The trial will assess the safety of THR-317 and will look at best corrected visual acuity and retinal thickness to evaluate the product’s efficacy.
Oncurious NV – Developing TB-403 for Pediatric Brain Cancers
Oncurious is developing TB-403 for the treatment of pediatric tumors.
TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival. Medulloblastoma is the most common pediatric malignant brain tumor, accounting for 20% of all brain tumors in children.
Treatment with TB-403 in relevant animal models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival. The favorable safety profile of TB-403 has already been demonstrated in clinical trials in patients with other diseases.
In March 2016, Oncurious and its development partner BioInvent International signed a partnership agreement with the Neuroblastoma and Medulloblastoma Translational Research Center (NMTRC) to accelerate the clinical development of TB-403 for the treatment of medulloblastoma in the US. The NMTRC is a non-profit organization with the mission to bring forward new effective therapies against neuroblastoma and medulloblastoma. Headquartered at Helen DeVos Children’s Hospital in Grand Rapids, MI, NMTRC is a network of 18 leading university hospitals and pediatric clinics in the US.
In May, Oncurious and BioInvent announced that they had initiated a Phase I/IIa study with TB-403. The study, which is being conducted by NMTRC, aims to recruit 27 patients with Relapsed or Refractory Medulloblastoma.
JETREA Update
JETREA® Regulatory & Markets Access
ThromboGenics’ first commercial drug JETREA® is now approved in 54 countries and reimbursed in over 20 countries.
Globally, around 25,000 patients have received a treatment with JETREA®.
The successful development of JETREA® demonstrates ThromboGenics pioneering role in developing pharmacological vitreolysis as a new drug class and treatment option for symptomatic vitreomacular adhesion or vitreomacular traction.
Further JETREA® submissions, approvals and country launches are anticipated in the remainder of 2016.
US FDA Approval for New ‘Already-Diluted’ Formulation of JETREA®
In June, ThromboGenics announced that the Office of Biotechnology Products of the U.S. Food and Drug Administration (FDA) had approved a new already-diluted formulation of JETREA® (ocriplasmin). The new formulation of JETREA® offers the additional benefit of eliminating the current preparatory dilution steps prior to injection.
ThromboGenics Inc., which is commercializing JETREA® in the US, plans to launch the already-diluted formulation of JETREA® in the first half of 2017.
Ocriplasmin Research Findings Presented at ARVO
New JETREA® research findings were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2016 annual meeting in Seattle at the beginning of May.
15 ocriplasmin-related presentations, abstracts and posters were delivered at ARVO. These covered preclinical research findings, real-world clinical data, and further characterization of results from different studies, including OASIS, ORBIT, and OVIID conducted in the US and Europe.
The data update confirmed the product’s safety profile as described in the approved product label, with no new safety signals. Moreover, these new clinical studies and real-world data continued to confirm that appropriate patient selection leads to improved treatment outcomes.
Ocriplasmin ORBIT and OASIS Data Presented at ASRS, San Francisco
Ocriplasmin clinical data were presented during the 34th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) which took place from August 9 to 14 in San Francisco.
During this premier educational retina meeting, Dr Mathew MacCumber presented “ORBIT, A Phase IV Clinical Study: Lessons Learned From Patient Selection Criteria for Ocriplasmin Intravitreal Injection”.
In addition, Dr Joseph Coney presented “data from the OASIS Trial: Natural History of Symptomatic Vitreomacular Adhesion”.
Dr Michael Tolentino presented “Efficacy and Safety Outcomes in Subjects with Full-Thickness Macular Hole”, also from the OASIS trial.
Ocriplasmin OASIS Phase III b 2 Year Follow- Up Study Published in Ophthalmology, AAO Journal
The full report of the 2 year follow up of the OASIS study evaluating JETREA® (ocriplasmin) for the treatment of Symptomatic VMA/VMT and Macular Hole (n=220) has been published in Ophthalmology, Journal of the American Academy of Ophthalmology.
OASIS was designed to provide long term controlled efficacy and safety data for JETREA® in patients being treated for symptomatic vitreomacular adhesion (sVMA). The study included 24 months follow up data the longest period patients have been studied post treatment with this novel medicine.
In its overall conclusion, Ophthalmology confirms 'the OASIS data demonstrates the long-term efficacy and safety of ocriplasmin, providing improved resolution of symptomatic VMA compared with previous phase 3 trials, with no additional safety signals identified'.
The article ‘Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial’ can be consulted online here.
OASIS data, and its positive conclusions, will be shared further through presentations and publications which may be expected prior to and during the upcoming AAO meeting in Chicago, (Oct 15 -18, 2016).
Financial review
In the first half of 2016, ThromboGenics had total revenues of €4.0 million, including €2.4 million of JETREA® sales in the US, €1.4 million in royalties from Alcon (Novartis) based on its ex-US sales of JETREA® the remaining being miscellaneous product Sales. In the corresponding period in 2015, ThromboGenics reported a total income of €6 million.
During the first six months of 2016, the Group reported a gross profit of €2.6 million.
In the first half of 2016, ThromboGenics’ R&D expenses were €12.0 million, including a €3.4 million depreciation in intangible assets relating to ocriplasmin Phase III program. This compares with €10.3 million of R&D expenses in the same period in 2015.
In the first half of 2016, selling and marketing expenses amounted to €2.2 million compared with €10.2 million in the corresponding period in 2015. The cost reduction is due to the full effect of the reduction in size of our US organization which took place in 2015. ThromboGenics Inc is now a lean customer-centric organization that is continuing to support JETREA® via a well-established distribution network.
For the first half of 2016, ThromboGenics reported a net loss of €15.0 million, or €0.42 per share. In the corresponding period in 2015 the Company reported a net loss of €19.2 million or €0.53 per share.
At the end of June 2016, ThromboGenics had €91.5 million in cash and investments. This compares to €101.4 million on December 31, 2015.
