PADciclo (ciclosporin ophthalmic) / MC2 Therap, Moorfields Eye Hospital - LARVOL DELTA

Topical ciclosporin A for severe ocular surface inflammation: a real-world series of 1221 cases. (PubMed, Eye (Lond)) - No abstract available

Journal • Real-world • Real-world evidence • Inflammation • Ocular Inflammation

Peripheral Ulcerative Keratitis Associated With Lichen Planus. (PubMed, Cornea) - "Ocular manifestations of lichen planus are rare and mostly involve the conjunctiva; however, PUK might also develop, presumably due to its similar mechanisms with other T-cell autoimmune diseases. Systemic immunosuppression is required initially but further control of the ocular surface can be achieved successfully with topical ciclosporin."

Journal • Dermatology • Dermatopathology • Immunology • Inflammation • Keratitis • Lichen Planus • Ocular Inflammation • Ophthalmology

Management of inflammation in dry eye disease: Recommendations from a European panel of experts. (PubMed, Eur J Ophthalmol) - "This consensus fills some of the knowledge gaps in previous recommendations regarding the use of topical corticosteroids and CsA in patients with DED."

Journal • Review • Dry Eye Disease • Immunology • Inflammation • Ocular Inflammation • Ophthalmology

Dual inhibition of complement component 5 and leukotriene B4 by topical rVA576 in atopic keratoconjunctivis: TRACKER phase 1 clinical trial results. (PubMed, Orphanet J Rare Dis) - "In this open label phase 1 TRACKER trial, rVA576 eye drops were well tolerated and showed a response across signs and symptoms of active inflammation. This study is exploratory but supports topical rVA576 safety and shows promising efficacy for recalcitrant AKC. A phase 2 randomised control trial is currently underway."

Clinical • Journal • P1 data • Conjunctivitis • Dry Eye Disease • Immunology • Inflammation • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

Clinical Characteristics of Patients With Chronic Stevens-Johnson Syndrome Treated at a Major Tertiary Eye Hospital Within the United Kingdom. (PubMed, Front Med (Lausanne)) - "In conclusion, chronic SJS within the UK population under tertiary care remains an area of unmet clinical need. Current medical and surgical modalities prevent worsening of vision in severe ocular disease from SJS."

Clinical • Journal • Infectious Disease • Ocular Inflammation • Ophthalmology • Steven-Johnson Syndrome

[VIRTUAL] MC2-03 (CICLOSPORIN EYEDROPS) IMPROVES TEAR PRODUCTION IN SJÖGREN’S PATIENTS WITH MODERATE-TO-SEVERE KERATITIS: RESULTS FROM A PHASE 2B RANDOMIZED, CONTROLLED TRIAL (EULAR 2020) - "MC2-03 eye drops once daily rapidly increased tear production and further improved corneal staining in Sjögren´s patients with moderate to severe keratitis, which both are objectives included as diagnostic criteria for Sjögren’s disease. MC2-03 eye drops were well tolerated with no unexpected safety findings."

Clinical • P2b data • Dry Eye Disease • Immunology • Keratitis • Ocular Infections • Ocular Inflammation • Ophthalmology

MC2 Therapeutics announces topline results showing a favorable safety profile and reduction in corneal staining for MC2-03 in dry eye patients with moderate to severe keratitis (Businesswire) - "MC2 Therapeutics...announced topline results from the MC2-03-C1 Northern Lights Phase 2 trial evaluating the safety and efficacy of MC2-03 (PADciclo) in moderate-to-severe dry eye (DED) patients. MC2-03 is an eye drop containing ciclosporin (CsA) formulated using MC2 Therapeutics’ proprietary PAD™ Technology to enable improved penetration into ocular tissues without the use of excipients that can cause ocular safety concerns. Topline results will be presented at the Ophthalmology Innovation Summit (OIS) in Chicago on October 25th, 2018."

P2 data • Dry Eye Disease • Ophthalmology

Efficacy of MC2-03 ciclosporin eyedrops on HLA-DR expression in patients with moderate to severe dry eye and its correlation to corneal staining severity (ARVO 2020) - "HLA-DR expression in individual patients correlated with their corneal staining severity at Baseline (p<0.01). The change in HLA-DR expression from Baseline to Month 6 correlated to the proportion of MC2-03 treated patients obtaining clear to mild corneal staining at Month 6 (p<0.05).Conclusions Changes in HLA-DR expression in conjunctival cells and its appropriate correlation with corneal staining severity strongly support the treatment efficacy of MC2-03 ciclosporin eye drops for patients with moderate to severe dry eye, particularly Sjögren syndrome patients."

Clinical

Clinical efficacy of MC2-03 (ciclosporin eye drop) in treatment of dry eye disease patients with severe keratitis randomized in the NORTHERN LIGHTS phase 2b trial (EVER 2019) - No abstract available.

Clinical • P2b data

EFFICACY DATA OF MC2–03 (CICLOSPORIN 0.03% AND 0.06% EYEDROPS) IN SJOGREN’S PATIENTS WITH SEVERE KERATITIS: OUTCOMES OF THE NORTHERN LIGHTS PHASE 2B TRIAL (EULAR 2019) - "Data from the NORTHERN LIGHTS trial show that MC2-03 ciclosporin eyedrops has the potential to be a safe, well-tolerated and efficient treatment in Sjogren’s patients."

Clinical • P2b data

The Good, the Bad and the Ugly in Dry Eye Disease: new treatments, challenging cases and “difficult” patients (RCOphth 2019) - "Attendees will learn how best to assess dry eye patients, to understand the evidence for topical ciclosporin and its role in 2019, when to use other treatments such as autologous serum for complex cases, and the increasing evidence of dry eye as a chronic pain syndrome. Participation will, we hope, allow improved treatment paradigms to deliver evidence-based and personalised treatment for patients with dry eye disease."

Clinical

MC2-03, an innovative ciclosporin eyedrop, shows favorable safety and tolerability after 6 months of treatment in moderate-to-severe DED patients (ARVO 2019) - "There was no evidence of a sustained rise in IOP above normal physiological limits in neither the ciclosporin arms nor the vehicle and lubricant groups. Conclusions The present results confirm favourable tolerability and safety of the MC2-03 eye drop."

Clinical

Oral immunosuppression practice for inflammatory eye disease: A one-year analysis of prescriptions at Moorfields Eye Hospital (ARVO 2019) - "In general, steroid was the most frequently prescribed first line agent, and mycophenolate mofetil the preferred second-line agent, but there was variation between specialties. This may reflect the efficacy of different medicines for different ocular diseases, and also different preferences amongst prescribers in view of the different side effect profiles of the medicines."

Clinical

TITLE: Clinical and immunologic characteristics of European patients randomized for NORTHERN LIGHTS phase 2b study that assessed MC2-03 (ciclosporin 0.03% and 0.06%) for the treatment of moderate-to-severe dry eye disease. (ARVO 2019) - "Among this specific group of patients, 58% had a CFS 4 at baseline (n=38). Conclusions The NORTHERN LIGHTS study shows a typical distribution for the patients enrolled in the study."

Clinical • P2b data