Safety, Tolerability and Preliminary Efficacy of Unilateral Latanoprost-loaded Punctual Plug -EXP-LP

Summary

Glaucoma is the most frequent cause of irreversible \& preventable blindness worldwide, affecting about 2% of the world's population in people over 40. The major risk factor, and only treatable factor in glaucoma, is increased intraocular pressure (IOP). IOP reduction can slow or arrest the progression of vision loss. Current treatment consists of drops administered on a daily basis with unfortunately low patient compliance, increasing the chance of blindness. Eximore's product aims to eliminate the need to apply eye drops on a daily basis and thus solves the significant problem of patient compliance.

Timeline

Start

2018-06-01

Primary completion

2019-06-01

Completion

2019-09-01

Publications

• Results Boland MV, Ervin AM, Friedman DS, Jampel HD, Hawkins BS, Vollenweider D, Chelladurai Y, Ward D, Suarez-Cuervo C, Robinson KA. Comparative effectiveness of treatments for open-angle glaucoma: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 Feb 19;158(4):271-9. doi: 10.7326/0003-4819-158-4-201302190-00008.
• Results Burr J, Azuara-Blanco A, Avenell A, Tuulonen A. Medical versus surgical interventions for open angle glaucoma. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD004399. doi: 10.1002/14651858.CD004399.pub3.
• Results Chen R, Yang K, Zheng Z, Ong ML, Wang NL, Zhan SY. Meta-analysis of the Efficacy and Safety of Latanoprost Monotherapy in Patients With Angle-closure Glaucoma. J Glaucoma. 2016 Mar;25(3):e134-44. doi: 10.1097/IJG.0000000000000158.
• Results Cucherat M, Stalmans I, Rouland JF. Relative efficacy and safety of preservative-free latanoprost (T2345) for the treatment of open-angle glaucoma and ocular hypertension: an adjusted Indirect comparison meta-analysis of randomized clinical trials. J Glaucoma. 2014 Jan;23(1):e69-75. doi: 10.1097/IJG.0b013e3182a075e6.
• Results Eveleth D, Starita C, Tressler C. A 4-week, dose-ranging study comparing the efficacy, safety and tolerability of latanoprost 75, 100 and 125 mug/mL to latanoprost 50 mug/mL (xalatan) in the treatment of primary open-angle glaucoma and ocular hypertension. BMC Ophthalmol. 2012 May 18;12:9. doi: 10.1186/1471-2415-12-9.
• Results Garway-Heath DF, Crabb DP, Bunce C, Lascaratos G, Amalfitano F, Anand N, Azuara-Blanco A, Bourne RR, Broadway DC, Cunliffe IA, Diamond JP, Fraser SG, Ho TA, Martin KR, McNaught AI, Negi A, Patel K, Russell RA, Shah A, Spry PG, Suzuki K, White ET, Wormald RP, Xing W, Zeyen TG. Latanoprost for open-angle glaucoma (UKGTS): a randomised, multicentre, placebo-controlled trial. Lancet. 2015 Apr 4;385(9975):1295-304. doi: 10.1016/S0140-6736(14)62111-5. Epub 2014 Dec 19.
• Results Kompella UB, Kadam RS, Lee VH. Recent advances in ophthalmic drug delivery. Ther Deliv. 2010 Sep;1(3):435-56. doi: 10.4155/TDE.10.40.

Drugs

Indications