Taptiqom (tafluprost/timolol) / Santen, AGC Biologics - LARVOL DELTA

Santen Announces China NMPA Approval of Tapcom in Patients with Open-Angle Glaucoma or Ocular Hypertension (Santen Press Release) - "Santen Pharmaceutical...announced that the National Medical Products Administration (NMPA) of China, has approved the Marketing Authorization Application for Tapcom (generic name: tafluprost/timolol maleate, development code: STN1011101)....Tapcom is for lowering intraocular pressure (IOP) of patients with open-angle glaucoma or ocular hypertension, offering new treatment options to patients for whom topical beta-blockers or prostaglandin derivatives monotherapies failed to achieve target IOP, and to patients who may benefit from preservative-free eye drops during long-term topical use of glaucoma medication."

China approval • Glaucoma • Ophthalmology

A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P3 | N=219 | Completed | Sponsor: Santen Pharmaceutical Co., Ltd. | Unknown status ➔ Completed | N=324 ➔ 219 | Trial completion date: Mar 2022 ➔ Apr 2023 | Trial primary completion date: Mar 2022 ➔ Apr 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Glaucoma • Ophthalmology

Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: Santen Pharmaceutical (Taiwan) Co., LTD | Recruiting ➔ Completed

Real-world evidence • Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Responder rate and investigator/patientreported assessment of efficacy and tolerability regarding the preservative-free tafluprost/ timolol fixed-dose combination in the treatment of open-angle glaucoma and ocular hypertension: country-level analysis from the VISIONARY study (EGS 2022) - "Patients included in the VISIONARY study from Hungary, Italy, Latvia, Russia, Spain and the UK demonstrated significant IOP reduction on PF tafluprost/timolol FC therapy compared to prior monotherapy; this was present from Week 4 through Month 6. Most patients in each country achieved IOP reductions of at least 20%, and most investigators considered PF tafluprost/timolol FC therapy more effective than prior monotherapy. Both treatment compliance and patient-reported tolerability were high in all study countries."

Clinical • Glaucoma • Ophthalmology

Results after treatment with MicroShunt PreserFlo® of refractory to medical treatment congenital glaucoma in a patient with mycosis fungoides included in clinical trial ASTX660 (EGS 2022) - "Treatment prescribed was mannitol 20% IV, furosemide, acetazolamide 250mg/8h, Combigan® /12h and Lumigan® /12h, reaching an IOP OD of 30 mmHg 2 hours later... Minimally penetrating surgeries represent a new therapeutic step in the surgical treatment of glaucoma. In refractory cases to medical therapy, the microshunt can achieve an adequate intraocular pressure control with a good safety profile, resorting to more invasive surgeries in the future."

Clinical • Cataract • Glaucoma • Ophthalmology

Baseline intraocular pressure affects treatment outcome with the preservative-free tafluprost/ timolol fixed-dose combination in open angle glaucoma and ocular hypertension: subanalysis from the VISIONARY study (EGS 2022) - "In OAG/OHT patients with baseline IOP ≥ 15 mmHg under monotherapy, a switch to PF tafluprost/timolol FC resulted in a significant IOP reduction at Week 4 that was sustained throughout the 6-month study period. In the current subanalysis of the VISIONARY study the highest reduction in IOP was seen in those with baseline under monotherapy pressures ≥ 20 mmHg."

Clinical • Glaucoma • Ophthalmology

A comparison of country-level data from the VISIONARY study examining treatment outcomes with preservative-free tafluprost/timolol fixed-dose combination therapy. (PubMed, Curr Med Res Opin) - "Within country, outcomes were consistent regardless of diagnosis, dosing or prior monotherapy. Treatment was generally well tolerated."

Combination therapy • Journal • Asthma • Glaucoma • Immunology • Ophthalmology • Respiratory Diseases

Switching to Preservative-Free Tafluprost/Timolol Fixed-Dose Combination in the Treatment of Open-Angle Glaucoma or Ocular Hypertension: Subanalysis of Data from the VISIONARY Study According to Baseline Monotherapy Treatment. (PubMed, Adv Ther) - "PF tafluprost/timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively."

Journal • Monotherapy • Glaucoma • Ophthalmology

Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting (clinicaltrials.gov) - P=N/A; N=1; Recruiting; Sponsor: Santen Pharmaceutical (Taiwan) Co., LTD; Not yet recruiting ➔ Recruiting; Trial completion date: Dec 2021 ➔ Aug 2022; Initiation date: Apr 2021 ➔ Sep 2021; Trial primary completion date: Dec 2021 ➔ Aug 2022

Clinical • Enrollment open • Real-world evidence • Trial completion date • Trial initiation date • Trial primary completion date • Glaucoma • Ophthalmology

A phase 1/2 study with birinapant in combination with pembrolizumab. (ASCO 2018) - P1/2; "The phase 2 part plans to include 111 patients. The phase 2 secondary objectives are safety and tolerability, tumor response, progression-free and overall survival. Exploratory objectives will assess tumor response by iRECIST, pharmacokinetics, pharmacodynamics and predictive biomarkers."

Combination therapy • IO biomarker • P1/2 data • PD(L)-1 Biomarker • Biliary Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Mesothelioma • Ovarian Cancer • Small Cell Lung Cancer

Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost/Timolol Fixed-Dose Combination Therapy: UK and Ireland Results from the VISIONARY Study. (PubMed, Adv Ther) - "Treatment with PF Taf-T FC resulted in significant reductions in mean IOP over 6 months. Patients and physicians reported that treatment was well tolerated. These data demonstrate real-world efficacy of PF Taf-T FC for the treatment of OAG and OHT in routine clinical practice in the UK and Ireland."

Combination therapy • Journal • Glaucoma • Ophthalmology

Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting (clinicaltrials.gov) - P; N=1; Not yet recruiting; Sponsor: Santen Pharmaceutical (Taiwan) Co., LTD

New trial • Glaucoma • Hypertension • Ophthalmology

[VIRTUAL] Panuvieits in an elderly patient (ESCRS-WM 2021) - " Topical azopt was added to taptiqom for IOP control...She was commenced on oral azithromycin and a reducing dose of concomitant oral prednisolone... One-third of the world's human population is infected by Toxoplasma gondii. Serum IgM titre has a sensitivity of 99.4% and a specificity of 49.2%. Serum IgG titre sensitivity and specificity varies depending on the threshold limit used for diagnosis."

Clinical • Glaucoma • Ocular Infections • Ocular Inflammation • Ophthalmology • Uveitis

Bacillus subtilis DE111 intake may improve blood lipids and endothelial function in healthy adults. (PubMed, Benef Microbes) - "These data suggest that B. subtilis supplementation may be beneficial for improving risk factors associated with CVD. Further studies in populations of older adults or those with dyslipidaemia and endothelial dysfunction is warranted."

Clinical • Journal • Cardiovascular • Dyslipidemia • Immunology • Inflammation

Daily intake of probiotic strain Bacillus subtilis DE111 supports a healthy microbiome in children attending day-care. (PubMed, Benef Microbes) - "In addition, a decrease in Eisenbergiella (P<0.001), Lactobacillales (P<0.01) and Streptococcaceae (P<0.01), which is considered pro-inflammatory, were also observed in the probiotic group. Together with a reduction of the F/B ratio observed in the probiotic group, these results suggest probiotic supplementation with Bacillus subtilis DE111 introduce subtle but positive changes in the microbiome of children aged 2-6 years old."

Clinical • Journal • Immunology • Inflammation • Pediatrics

Effects of Probiotic (Bacillus subtilis) Supplementation During Offseason Resistance Training in Female Division I Athletes. (PubMed, J Strength Cond Res) - "Twenty-three Division I female athletes (19.6 ± 1.0 years, 67.5 ± 7.4 kg, and 170.6 ± 6.8 cm) participated in this study and were randomized into either a probiotic (n = 11; DE111) or placebo (n = 12; PL) group while counterbalancing groups for sport...No other group differences were observed. These data suggest that probiotic consumption in conjunction with post-workout nutrition had no effect on physical performance but may improve body composition in female Division I soccer and volleyball players after offseason training."

Journal

GlutDigestP: GlutDigest - Pilot Study (clinicaltrials.gov) - P=N/A; N=2; Completed; Sponsor: Deerland Enzymes; Recruiting ➔ Completed

Clinical • Trial completion

Efficacy and safety of the fixed combinations of tafluprost/timolol and latanoprost/carteolol. (PubMed, Sci Rep) - "In addition, TAF/TIM showed much less cytotoxic effects compared to LAT/CAR on the human corneal epithelial cells. Our findings showed that TAF/TIM is better than LAT/CAR with regard to the IOP-lowering effect in monkeys and toxicity on ocular surface."

Clinical • Journal

Preservative-free fixed combination in the treatment of open-angle glaucoma and ocular hypertension: the VISIONARY Study (EUPAS22204) (PubMed, Vestn Oftalmol) - "In clinical practice, PF tafluprost/timolol FC provided statistically significant IOP reductions in patients with POAG and OH insufficiently controlled by or intolerant to monotherapy with topical beta-adrenoblockers or a prostaglandin analogue. The highest IOP reduction was seen at week 4 and was maintained over the 6-month study period. There was also a decrease in the severity of symptoms of ocular surface condition."

Journal • Dry Eye Disease • Glaucoma • Hypertension • Ophthalmology • Pruritus

GlutDigestP: GlutDigest - Pilot Study (clinicaltrials.gov) - P=N/A; N=6; Recruiting; Sponsor: Deerland Enzymes

Clinical • New trial

GlutDigest: Digestion of Gluten in the Presence of Enzymes (clinicaltrials.gov) - P=N/A; N=15; Recruiting; Sponsor: Deerland Enzymes

New trial

Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation (clinicaltrials.gov) - P=N/A; N=22; Completed; Sponsor: Lipscomb University

Clinical • New trial

3-months study to evaluate the efficacy and tolerability of the drug tafluprost –timolol without preservatives in people with glaucoma or high pressure in the eyes that have already taken latanoprost with preservative. Studio della durata di 3 mesi per valutare l'efficacia e la tollerabilità del farmaco tafluprost –timololo senza conservanti in persone con glaucoma o pressione alta agli occhi... (clinicaltrialsregister.eu) - P4; N=43; Ongoing; Sponsor: IRCCS FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA ONLUS

Clinical • New P4 trial • Glaucoma • Hypertension • Ophthalmology

Effects of topical administration of tafluprost and combination of tafluprost and timolol or tafluprost and betaxolol on Schirmer tear test, intraocular pressure, and pupil size in clinically healthy dogs. (PubMed, Int Ophthalmol) - "Tafluprost alone or in combination with timolol and betaxolol was able to reduce intraocular pressure. The greatest effect of the drugs occurred 6 and 8 h PI. The present study revealed that the combination of tafluprost/betaxolol is more potent in decreasing IOP than tafluprost alone or a combination of tafluprost/timolol in healthy dogs."

Clinical • Journal • Glaucoma • Ophthalmology

[VIRTUAL] Severe Limbal Stem Cell Deficiency and Cicatricial Conjunctivitis Secondary to Preserved Glaucoma Eyedrops (ASCRS-ASOA 2020) - "The patient was using brinzolamide, bimatoprost, and brimonidine-timolol...Results All eyedrops were stopped, and the patient was started on non-preserved dorzolamide-timolol and tafluprost...BAK disrupts cells, which is responsible not only for its antimicrobial actions, but also its toxicity. Management involves removal of the offending agent and monitoring for progression."

Cataract • Conjunctivitis • Dermatology • Dermatopathology • Glaucoma • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology