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Safety in Lactation: Drugs used in nasal allergy

27 October 2020Drugs used for nasal allergy have limited systemic absorption in the mother, and pose negligible risk to a breastfed infant. There is no published evidence…

Safety in Lactation: Topical corticosteroids

23 September 2020Topical corticosteroids are considered to pose a negligible risk to a breastfeeding infant as long as precautions are taken to avoid direct contact of the…

Is there a place in therapy for Kenalog® (triamcinolone acetonide) intramuscular injection for seasonal allergic rhinitis (hay fever)?

9 July 2019Kenalog® (triamcinolone acetonide) intramuscular injection used to be commonly prescribed for the treatment of treat hay fever in UK general practice; particularly in patients who…
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Lactation Safety Information

Local injection

Local injection
Yes
24 September 2020

For intranasal use

For intranasal use
Yes
24 September 2020

For topical use

For topical use
Yes
High potency
In UK topical triamcinolone only available in combination with chlortetracycline, with which there are no additional risks
24 September 2020

New Medicines

XipereNon-infectious uveitis (pan, anterior, intermediate and posterior)-associated macular oedema

Information

Xipere
New formulation
Clearside Biomedical
Clearside Biomedical

Development and Regulatory status

None
None
Pre-registration (Filed)
May 21Clearside Biomedical announce resubmission of NDA [9].
Dec 20Also in PIII development in China as ARVN001 [8]
Nov 20Company update reports plans to resubmit licence application in the US no later than H1 2021 [7]
Oct 19Licence application in the US has been rejected. The FDA did not identify any efficacy issues, and there were no requests for further clinical efficacy studies, but additional stability data and reinspection of the drug product manufacturer were requested, as well as a request for additional data on clinical use of the microinjector delivery system. The company plans to address the FDA´s recommendations and resubmit the application Q1 2020 [6].
Feb 19Filed in the US with a PDUFA action date of Oct 19 and launch anticipated Q1 2020 [5]
Mar 18Following positive trial results, Clearside Biomedical anticipate submission of a new drug application for triamcinolone acetonide in patients with macular oedema associated with uveitis to the FDA Q4 2018, and are also evaluating options for submissions to regulatory agencies outside of the US [4].

Category

A suprachoroidal injectable suspension of triamcinolone acetonide
Prevalence of uveitis is variously given as 25-50 per 100,000 persons, with the mean onset at 30.7 years of age. Most people who develop uveitis are aged 20-50 years. Roughly 5% to 10% of these cases occur in children under the age of 16 [1].
Non-infectious uveitis (pan, anterior, intermediate and posterior)-associated macular oedema
For suprachoroidal injection
Intraocular

Trial or other data

Mar 18 Positive topline results announced from the PIII PEACHTREE trial of CLS-1001 in patients (n=160) with macular oedema associated with non-infectious uveitis. 47% of patients who received treatment every 12 weeks gained at least 15 letters in best corrected visual acuity (BCVA), as measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale, from baseline at week 24, vs 16% of patients who received placebo (p
Apr 17 PIII AZALEA study (NCT03097315) initiated to evaluate the safety of triamcinolone acetonide suprachoroidal injectable suspension (CLS TA) in patients with non-infectious uveitis. The open-label study is expected to enrol 38 subjects in the US, and the estimated primary completion date is Feb 18 [4]
Jan 17Clearside Biomedical initiates the PIII SAPPHIRE trial to evaluate safety and efficacy of triamcinolone acetonide suprachoroidal injectable suspension in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion (NCT02980874; CLS1003-301). The double-blind, parallel, prospective, randomised trial is enrolling approximately 460 patients in the US [2].
Dec 16Clearside Biomedical initiates the PIII MAGNOLIA trial, a non-interventional extension of the parent study, CLS1001-301, to characterise the continued clinical benefit(s) regarding safety and efficacy of triamcinolone acetonide suprachoroidal injectable suspension, for the treatment of macular edema associated with non-infectious uveitis (NCT02952001; CLS1001-303). The prospective trial is enrolling approximately 30 patients in the US [2].
Oct 16PIII PEACHTREE study (NCT02595398) is still recruiting patients. Collection of primary outcome data expected to complete Jul 17 [3].
Dec 15Clearside announces enrolment of the first patient in the PIII PEACHTREE trial (CLS1001-301; NCT02595398). The study will evaluate safety and efficacy of triamcinolone acetonide suprachoroidal injectable suspension, in patients with macular oedema associated with non-infectious uveitis. The primary endpoint of the trial is the proportion of patients with a change in baseline of at least 15 letters in best corrected visual acuity (BCVA) as measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale at 24 weeks. The study is expected to enrol approximately 150 patients in the US [2].