carotuximab ophthalmic (DE-122) / Tracon Pharma, Santen - LARVOL DELTA

Safety and Tolerability of Intravitreal Carotuximab (DE-122) in Patients With Persistent Exudative Age-Related Macular Degeneration: A Phase I Study. (PubMed, Transl Vis Sci Technol) - "In this study, carotuximab was generally well tolerated, with no serious AEs reported, when administered as a single intravitreal injection to patients with persistent exudative AMD. Further characterization of the safety and efficacy of carotuximab will be needed to determine what role it may have in the treatment of exudative AMD."

Clinical • Journal • P1 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • ENG

Reduction of Opioid Overprescribing and Use Following Standardized Educational Intervention: A Survey of Patient Experiences Following Anorectal Procedures. (PubMed, Dis Colon Rectum) - "Educational interventions emphasizing evidence-based recommended opioid prescription quantities and regimented multimodal pain regimens are effective in decreasing excessive opioid prescribing and use without compromising satisfactory pain control in patients undergoing ambulatory anorectal procedures. See Video Abstract at http://links.lww.com/DCR/B529."

Clinical • Journal • Anesthesia • Pain

Cirugía cardiaca pediátrica mínimamente invasiva: experiencia de un centro colombiano cardiovascular. (PubMed, Arch Cardiol Mex) - "Los pacientes MICS tuvieron un lactato al ingreso y una estadía en la UCI menor que los controles. Conclusión: El abordaje MICS resulta ser una técnica novedosa, menos invasiva, segura y eficiente, frente al abordaje quirúrgico CONV, para la reparación de cardiopatías congénitas simples en paciente pediátricos."

Journal • Cardiovascular

Emerging Therapies in Neovascular Age-Related Macular Degeneration in 2020. (PubMed, Asia Pac J Ophthalmol (Phila)) - "For nAMD: Abicipar pegol, an intravitreal anti-vascular endothelial growth factor based on designed ankyrin repeat proteins (DARP) in protein, is currently pending approval. Conbercept and Faricimab, 2 intravitreal anti-growth factors, are currently in phase 3. Nine other upcoming agents have at least produced results in the 2A phase including intravitreal injections (KSI-301, OPT-302, RGX-314, ICON-1, and DE-122), depot (GB-102), drug reservoir (PDS), topical drops (PAN-90806), and oral formulations (AKST4290). We summarize all the newer molecules."

Journal • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Gene Therapies • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects (clinicaltrials.gov) - P2; N=76; Completed; Sponsor: Santen Inc.; Recruiting ➔ Completed

Clinical • Combination therapy • Monotherapy • Trial completion

Product discontinued (GlobeNewswire) - Wet - AMD

"$TCON and Santen Discontinue Development of DE-122 for Wet AMD https://t.co/2PmGuZ87yG" (@BioStocks)

DE-122: Data from P2 AVANTE trial (NCT03211234) in wet AMD in H1 2020 (Tracon Pharmaceuticals) - Corporate Presentation

P2 data

DE-122: Completion of P2 AVANTE trial (NCT03211234) in wet AMD in FY 2019 (Santen) - Q2 FY 2019 Results

Trial completion date

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Santen Pharmaceutical has steady sales in Asia and started sales and profit growth in 1Q aiming to increase sales in Japan [Google Translation] (Money Voice) - "DE-122 'Anti-endoglin antibody' targets wet-AMD. Currently, it is Phase 2a, and the plan aims to end Phase 2a in the second half of FY2019. Regarding DE-076C 'Vekacia / Verkazia', ​​there are some areas that are already on the market. In addition, this year, we are aiming for approval in the Asian countries for the calendar year."

Non-US regulatory • Trial status

TRACON Pharmaceuticals reports second quarter 2019 financial results and provides corporate update (Tracon Pharmaceuticals Press Release) - "...Santen announced the completion of enrollment in the randomized Phase 2 AVANTE study of DE-122 in combination with Lucentis® (ranibizumab) in patients with wet age-related macular degeneration (AMD)...Top-line data, including the primary endpoint of mean change in best corrected visual acuity at six months...are expected in the first half of 2020."

Enrollment closed • P2 data

Tracon Pharmaceuticals reports fourth quarter and year-end 2018 financial results and provides corporate update (Tracon Pharmaceuticals Press Release) - "...AVANTE Phase 2 randomized trial assessing the efficacy of DE-122...in patients with wet AMD. The primary endpoint of the trial is unchanged and measures best corrected visual acuity. Top-line data from the study is expected in the first half of 2020. Santen is responsible for global development of DE-122 in eye disease and TRACON is entitled to receive up to $145M in additional developmental, regulatory and commercial milestones, as well as royalties on net sales ranging from the high single digits to low teen double digits."

Financing • P2 data

DE-122: Data from P2 AVANTE trial (NCT03211234) in wet AMD in H1 2020 (Tracon Pharmaceuticals) - Q4 2018 Results

P2 data

Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects (clinicaltrials.gov) - P2; N=76; Recruiting; Sponsor: Santen Inc.; N=56 ➔ 76; Trial completion date: Jul 2019 ➔ Jan 2020; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Combination therapy • Enrollment change • Monotherapy • Trial completion date • Trial primary completion date

DE-122: Completion of P2 AVANTE trial (NCT03211234) in wet AMD in H2 FY 2019 (Santen) - Q3 FY2018 Results

Trial completion date

Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects (clinicaltrials.gov) - P2; N=56; Recruiting; Sponsor: Santen Inc.; Trial completion date: Mar 2019 ➔ Jul 2019; Trial primary completion date: Feb 2019 ➔ Jun 2019

Trial completion date • Trial primary completion date

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Santen Pharma: J.P. Morgan Healthcare Conference (Santen) - Anticipated regulatory approval globally in FY2018 or later

Anticipated regulatory

Santen and Tracon announce initiation of a phase 2a study of DE-122 for the treatment of wet age-related macular degeneration (GlobeNewswire) - "Santen Pharmaceutical...and TRACON Pharmaceuticals...announced that Santen has initiated a Phase 2a clinical study of DE-122 in patients with wet age-related macular degeneration...initiation of the Phase 2a study triggers a US$7 million milestone payment from Santen to TRACON."

Trial initiation date

Carotuximab: Completion of P2a study (NCT03216902) for AMD in H1 2019 (Santen) - Q3 FY2017 Results

Trial completion date

Santen presents phase I/II data on DE-122 (Carotuximab) in patients with refractory wet age-related macular degeneration (PRNewswire) - P1/2, N=12; PAVE trial; Sponsor: Santen; "Santen Inc. today announced that the topline results from the Phase I/II study of DE-122...for refractory wet age-related macular degeneration (AMD) were presented at the 15th Annual Angiogenesis, Exudation, and Degeneration...study results also suggest bioactivity of DE-122 in refractory wet AMD patients, as measured by mean change in central retinal subfield thickness (CST) based on the spectral domain optical coherence tomography (SD-OCT)."

P1/2 data

TRC105: Data from P2 AVANTE trial (NCT03211234) in wet AMD in mid-2019 (Tracon Pharmaceuticals) - Q2 2018 Results

P2 data