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Safety in Lactation: Treatment of glaucoma

18 September 2020With the exception of acetazolamide (oral/IV) antiglaucoma drugs are administered as eyedrops which have limited systemic absorption in the mother, and pose negligible risk to…
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Lactation Safety Information

Yes
18 September 2020

New Medicines

DurystaGlaucoma and ocular hypertension - sustained-release intracameral implant

Information

Durysta
New formulation
Allergan
Allergan

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Launched
Mar 20Launched in the US. FDA approval is restricted to single use and Durysta is not recommended to be readministered to an eye that has already received the implant. Studies are ongoing or planned to address the safety and efficacy of multiple implants with the company hopeful that results of these will allow expansion of current labelling [17,18].
Mar 20FDA approved bimatoprost implant (Durysta). Allergan has five ongoing PIII studies to support further potential FDA label enhancement and rest of the world approvals [14,15].
Jul 19Filed in US for reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension [11].
Sep 18Launch planned for 2020; territory not stated [9].
Jan 18PIII trials (NCT02507687 and NCT02250651) still recruiting [8].
Dec 16PIII trials (NCT02507687 and NCT02250651) still recruiting [7]
Nov 15A sustained - release implant is under phase III development for the treatment of elevated intraocular pressure and glaucoma in the US, Canada, New Zealand, Australia and the EU [2].

Category

Prostaglandin F2alpha receptor agonist (new sustained release implant)
Glaucoma is one of the most common eye conditions encountered in primary and secondary care. In the UK, glaucoma is the second most common cause for registration of visual impairment; accounting for 9-12% of registrations in people over the age of 65 years. Primary open-angle glaucoma (POAG) is the most common type of glaucoma, accounting for over 70% of cases. Ocular hypertension affects 3-5% of the population over 40 years of age but only a small proportion of these people develop glaucoma [1].
Glaucoma and ocular hypertension - sustained-release intracameral implant
Intraocular

Trial or other data

May 20PIII ARTEMIS trial (NCT02250651; EudraCT2014-003186-24) completed [16].
Jul 19PIII randomised, triple blind ARTEMIS trial (NCT02247804) completed. The trial enrolled 594 patients internationally (incl US, Europe, Asia and Australia - not UK). Top-line results from the trial released by Allergan in June 2018 were positive. Bimatoprost SR reduced IOP by approximately 30% over 12 weeks, meeting the predefined criteria for non-inferiority to the comparator, timolol. Bimatoprost SR was also well tolerated in the majority of patients [12,13].
Mar 19Extension study to evaluate the long-term safety and efficacy of bimatoprost SR in patients with open angle glaucoma or ocular hypertension who completed 1 of the 4 phase III bimatoprost SR studies (192024-091, -092, -093, or -095) has started enrolment (NCT03891446). The PIII open-label, prospective trial is enrolling patients (n=600) in the US and may extend to other countries worldwide including the UK. Estimated completion date is Apr 2023 [12,13]
Feb 19Commencement of an international, multi-centre (incl UK) open label, non-randomised PIIIb study (NCT03850782) to evaluate and compare duration of effect of 2 doses of bimatoprost SR, administered as 1-3 cycles in a single eye in participants (n=200 planned) with OAG or OH. Estimated completion date Jul 23 [16].
Dec 18Allergan announced positive topline data for the PIII trial NCT02250651 (n=594). Bimatoprost SR reduced IOP by approximately 30% over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to timolol. Initial data showed the potential for the majority of patients to remain treatment-free for 1 year after the last implant was inserted. The magnitude of IOP lowering efficacy with bimatoprost SR observed in this study was similar to that observed with daily topical prostaglandin analogues. Bimatoprost SR was also well tolerated in the majority of patients. Additional safety data from this study and results from a second PIII study with an identical design will be reported in Q1 2019 [10].
Feb 18Estimated primary completion date for PIII trial NCT02250651 now Apr 19 and NCT02507687 now May 20 [8].
Dec 16Estimated primary completion date for PIII trial, NCT02507687, amended to April 2019 [7]
Jan 16Allergan initiated a phase III trial(NCT02507687) to assess the intraocular pressure lowering effect and safety of bimatoprost sustained release, compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension. The randomised, double-blind study intends to enrol 160 patients in the US, and has an estimated primary completion date of December 2017 [5,6].
Nov 15Allergan announces 6-month interim results from an ongoing 24-month PI/II dose-ranging, paired-eye controlled clinical trial clinical trial of 75 pts who received the implant via an intracameral injection in one eye (as 6, 10, 15, or 20 micrograms), and daily topical bimatoprost 0.03% in the other eye. This was a prospective, 24-month, dose-ranging, paired-eye, controlled clinical trial which aimed to evaluate the safety and efficacy of Bimatoprost SR in lowering intra-ocular pressure (IOP) in pts with open angle glaucoma and ocular hypertension. The overall mean IOP reduction from baseline at 4 months in study eyes that received a single Bimatoprost SR implant ranged from 7.2 to 9.5 mm Hg while pooled fellow eyes receiving once-daily treatment with topical bimatoprost 0.03% had a reduction of 8.4 mm Hg. A single dose of Bimatoprost Sustained-Release (SR) lowered intraocular pressure (IOP) in 92% (n= 69) of glaucoma pts at 4 months and 71% (n=53) at 6 months while demonstrating a favourable efficacy and safety profile [2,3].
Nov 15Allergan initiated the randomised, double-blind, sham-controlled phase III trial (192024-092; NCT02250651; EudraCT2014-003186-24) to assess the safety and efficacy of this sustained-release formulation in ~600 pts with glaucoma and ocular hypertension in the US, Canada, New Zealand, the UK and Denmark. The trial is currently recruiting and has an estimated primary completion date of February 2017. [2,4]

Evidence based evaluations

31 March 2020US Prescribing Label
4 March 2020US Summary Review