Dry Eye News and Research

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Dry eye is one of the most common complaints seen by eye doctors, accounting for nearly one fourth of all office visits. Caused by insufficient tear production or excessive tear evaporation, dry eye can be a mild, episodic feeling of discomfort associated with certain circumstances, such as exposure to dry, hot or windy environments; however, it can also be a chronic medical condition that, if left untreated, may lead to increased risk of infection or visual impairment.

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Can-Fite BioPharma Ltd, a biotechnology company traded on the Tel Aviv Stock Exchange, announced today that it has opened Investigational New Drug application (IND) with the United States Food and Drug Administration (US FDA). The IND is for Can-Fite's lead compound, CF101, for the treatment of patients with psoriasis. This is the third US IND for CF101, and the fourth for Can-Fite.

8 Jun 2010

Scientists present data on denufosol tetrasodium for CF at ATS 2010 International Conference

Inspire Pharmaceuticals, Inc. announced today that Inspire scientists and collaborators will present data on denufosol tetrasodium, an investigational therapy for cystic fibrosis, during an oral presentation at the American Thoracic Society 2010 International Conference May 14 - 19, 2010 in New Orleans, LA.

20 May 2010

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

Allergan, Inc. today announced that the United States Food and Drug Administration has approved ZYMAXID (gatifloxacin ophthalmic solution) 0.5%, a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms; Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumonia.

20 May 2010

RegeneRx Biopharmaceuticals prices underwritten public offering at $0.41 per unit

RegeneRx Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration in cardiovascular diseases, central nervous system injuries, ophthalmic indications and dermal wounds, announced the pricing of its previously announced underwritten public offering of 11,500,000 units of its securities at a public offering price of $0.41 per unit.

19 May 2010

Data from RGN-259 study published in Archives of Ophthalmology

RegeneRx Biopharmaceuticals, Inc. announced today the publication of the first human data from a case study of patients evaluated with its ophthalmic product candidate RGN-259. The data have been published in the May 2010 issue of Archives of Ophthalmology, an American Medical Association peer-reviewed journal.

14 May 2010

Resolvyx presents new data on RX-10001 for corneal herpes simplex virus infection at ARVO 2010

Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, today announced the presentation of data on its novel resolvins for the treatment of both ocular surface diseases and retinal diseases at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Fort Lauderdale, Florida, being held May 2-6, 2010.

7 May 2010

TearScience completes $44.5 million Series C funding

TearScience, a privately-held medical device company, today announced the completion of $44.5 million of Series C funding from new investors Essex Woodlands Health Ventures, Investor Growth Capital and General Catalyst. The company's existing investors, De Novo Ventures, Spray Ventures and Quaker Bio Ventures completed the round. The funding will allow TearScience to commercialize its devices designed for use by eye care professionals to diagnose and treat the most common form of chronic dry eye disease.

5 May 2010

Novel biomarker test predicts risk of disease progression in patients with Crohn's disease

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced new findings supporting a novel, algorithm-based biomarker test that helps clinicians effectively predict the risk of developing aggressive disease in patients with Crohn's disease.

4 May 2010

UCB, IBDWG announce recipients of 2010 Research Awards in IBD for GI Fellows

UCB and the Inflammatory Bowel Disease Working Group today announced the five recipients of the 2010 Research Awards in Inflammatory Bowel Disease for Gastroenterology Fellows, each of whom will receive a one-year $40,000 research grant for their original clinical or basic research.

4 May 2010

Ocera Therapeutics presents Phase 2 proof-of-concept study results of AST-120 in non-constipating IBS

Ocera Therapeutics, Inc. presented results yesterday from a Phase 2 proof-of-concept study of AST-120 (spherical carbon adsorbent) in the treatment of patients with non-constipating Irritable Bowel Syndrome (IBS) at DDW, the annual meeting of the American Gastroenterological Association. Data showed that subjects treated with AST-120 responded in a consistent manner with reduction in pain better than placebo at week four and at week eight, the primary time point for analysis. The company plans to initiate a Phase 2b study evaluating AST-120 in non-constipating IBS.

4 May 2010

Boston Scientific commences enrollment in trial comparing SCS to spine reoperation in FBSS patients

Boston Scientific Corporation today announced the start of patient enrollment in the EVIDENCE Clinical Trial, which compares the therapeutic effectiveness and cost effectiveness of spinal cord stimulation (SCS) therapy to spine reoperation in patients with failed back surgery syndrome (FBSS). The first patient was enrolled by Joseph Buwembo, M.D. and Krishna Kumar, M.D., F.R.C.S.C., at Regina General Hospital in Regina, Saskatchewan, Canada.

4 May 2010

ADVENTRX Pharmaceuticals announces 6-month stability data for Exelbine

ADVENTRX Pharmaceuticals, Inc. today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine™, manufactured at the Company's intended commercial manufacturing site. The 6-month stability data are on track to support the submission of the New Drug Application (NDA) for Exelbine.

4 May 2010

Acucela to present data on ACU-4429 oral visual cycle modulator for dry AMD at Retina International meeting

Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that Ryo Kubota, M.D., Ph.D., Acucela's chairman, president and chief executive officer, has been invited to participate in Retina International's annual Scientific & Medical Advisory Board meeting being held in Fort Lauderdale, Florida on May 3, 2010.

3 May 2010

Ethicon Endo-Surgery SEDASYS CAPS system receives European Union CE Mark, Health Canada approval

Ethicon Endo-Surgery today announced that the SEDASYS® System, the first computer-assisted personalized sedation (CAPS) system, was granted a CE Mark for the European Union for routine colonoscopy and screening of the upper gastrointestinal tract (EGD procedures), and Health Canada granted regulatory approval for the SEDASYS® System for use by healthcare professional teams during routine colonoscopy.

3 May 2010

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Abbott announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for CREON® (pancrelipase) Delayed-Release Capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas (exocrine pancreatic insufficiency) due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy). Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.

3 May 2010

Valeant Pharmaceuticals International reports 30% increase in total revenue for first-quarter 2010

Valeant Pharmaceuticals International today announced first quarter financial results for 2010.

3 May 2010

SARcode presents positive results from Phase 2 study of SAR 1118 ophthalmic solution at Dry Eye Summit

SARcode Corporation, a privately-held biotechnology company focused on developing a novel class of lymphocyte function-associated antigen-1 (LFA-1) antagonists, today announced results of a 230 patient Phase 2 proof-of-concept study evaluating topical SAR 1118 ophthalmic solution in the treatment of aqueous deficient dry eye (keratoconjunctivitis sicca).

3 May 2010

PolyTouch Medical files Premarket 510(k) application for PatchAssist laparoscopic mesh deployment device

PolyTouch Medical Ltd., a leading developer of laparoscopic hernia mesh placement technologies, today announced that it has filed a Premarket 510(k) Application with the US Food and Drug Administration for PatchAssist, an Innovative Laparoscopic Mesh Deployment and Placement Device that enables accurate mesh placement in laparoscopic ventral hernia repair potentially reducing procedure time by 30%-50%.

3 May 2010

Stimatix reports interim results from artificial sphincter trial for restoring bowel control in people with stoma

Stimatix GI, located in the Misgav Venture Accelerator, has reported encouraging interim results in its animal trials of the AOS-C1000 artificial sphincter, designed to provide stoma patients with a new means of bowel control.

3 May 2010

Inspire Pharmaceuticals reports net loss of $14.8M for first-quarter 2010

Inspire Pharmaceuticals, Inc. announced today financial results for the first quarter ended March 31, 2010, reporting a net loss of $14.8 million or ($0.18) per share.

3 May 2010

Dry Eye News and Research

Further Reading

Can-Fite BioPharma opens CF101 IND for psoriasis with US FDA

Scientists present data on denufosol tetrasodium for CF at ATS 2010 International Conference

FDA approves ZYMAXID ophthalmic solution for treatment of bacterial conjunctivitis

RegeneRx Biopharmaceuticals prices underwritten public offering at $0.41 per unit

Data from RGN-259 study published in Archives of Ophthalmology

Resolvyx presents new data on RX-10001 for corneal herpes simplex virus infection at ARVO 2010

TearScience completes $44.5 million Series C funding

Novel biomarker test predicts risk of disease progression in patients with Crohn's disease

UCB, IBDWG announce recipients of 2010 Research Awards in IBD for GI Fellows

Ocera Therapeutics presents Phase 2 proof-of-concept study results of AST-120 in non-constipating IBS

Boston Scientific commences enrollment in trial comparing SCS to spine reoperation in FBSS patients

ADVENTRX Pharmaceuticals announces 6-month stability data for Exelbine

Acucela to present data on ACU-4429 oral visual cycle modulator for dry AMD at Retina International meeting

Ethicon Endo-Surgery SEDASYS CAPS system receives European Union CE Mark, Health Canada approval

FDA approves Abbott's CREON sNDA including dosing guidance for treating EPI due to CP, pancreatectomy

Valeant Pharmaceuticals International reports 30% increase in total revenue for first-quarter 2010

SARcode presents positive results from Phase 2 study of SAR 1118 ophthalmic solution at Dry Eye Summit

PolyTouch Medical files Premarket 510(k) application for PatchAssist laparoscopic mesh deployment device

Stimatix reports interim results from artificial sphincter trial for restoring bowel control in people with stoma

Inspire Pharmaceuticals reports net loss of $14.8M for first-quarter 2010

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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