dexamethasone steroid (AR-1105) / Envisia Therap, Alcon - LARVOL DELTA

PHASE 2 RANDOMIZED STUDY (ORION-1) OF A NOVEL, BIODEGRADABLE DEXAMETHASONE IMPLANT (AR-1105) FOR THE TREATMENT OF MACULAR EDEMA DUE TO CENTRAL OR BRANCH RETINAL VEIN OCCLUSION. (PubMed, Retina) - "Both formulations were well tolerated and demonstrated clinically meaningful and sustained improvements in vision and retinal thickening in patients with retinal vein occlusion with longstanding edema."

Journal • P2 data • Hematological Disorders • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

Applicability of a web app for lung cancer risk calculation and personalized recommendations for screening in Mexico. (ASCO 2022) - "This pilot study showed a high response of Mexican population seeking lung cancer risk evaluation, especially among the persons who smoke regularly. The use of web apps can result in mass diffusion which will help reach people with less medical access, a common scenario in many developing countries. Further analysis should be made to measure the real impact on lung cancer diagnosis and oncological outcomes."

Lung Cancer • Oncology • Solid Tumor

Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - P2; N=49; Completed; Sponsor: Aerie Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion • Macular Edema • Ophthalmology • Retinal Vein Occlusion

Aerie Pharmaceuticals reports first quarter 2020 financial results and provides business update (Aerie Pharmaceuticals Press Release) - "The AR-1105...was fully enrolled ahead of schedule in October 2019 with a readout expected in the second half of 2020. The first-in-human clinical trial for AR-13503...commenced in the third quarter of 2019 for neovascular age-related macular degeneration and DME (diabetic macular edema). Aerie currently expects to commence enrollment of the Phase 2 clinical trial in the second half of 2020, with a readout expected in 2021....Aerie also plans to file a Prior Approval Supplement with the FDA in second-quarter 2020 to obtain FDA approval to manufacture Rhopressa® in Athlone for commercial distribution in the U.S. market....An opinion from the EMA’s Committee for Medicinal Products for Human Use on the MAA for Roclanda® is expected in the fourth quarter of 2020. Topline data from the Rocklatan® Mercury 3 Phase 3 clinical trial in Europe is expected potentially in late 2020, the results of which will help determine commercial prospects in the region."

Commercial • Enrollment status • P2 data • P3 data • Age-related Macular Degeneration • Diabetic Macular Edema • Glaucoma • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - P2; N=49; Active, not recruiting; Sponsor: Aerie Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Aerie Pharmaceuticals completes enrollment in the phase 2 trial of AR-1105 (dexamethasone intravitreal implant) in patients with macular edema associated with retinal vein occlusion ahead of schedule (Businesswire) - "Aerie Pharmaceuticals, Inc...announced that patient enrollment in its Phase 2 clinical trial of AR-1105 in patients with macular edema due to retinal vein occlusion (RVO) is complete several weeks ahead of schedule...A few additional patients are currently being screened and, if they are randomized, could bring the total number of patients in the final evaluation to a maximum of 49...We plan to conduct an interim analysis when the first 20 patients have reached the six month timepoint, which should be before the end of this year, making preliminary data available in 2020. The final patient visit should take place in Q2 2020."

Enrollment status • P2 data

Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Aerie Pharmaceuticals; Trial completion date: Jan 2020 ➔ Apr 2020; Trial primary completion date: Jan 2020 ➔ Apr 2020

Trial completion date • Trial primary completion date

Aerie Pharmaceuticals reports first quarter 2019 financial results and provides business update (Aerie Pharmaceuticals Press Release) - "The AR-1105 (dexamethasone steroid implant) Phase 2 clinical trial commenced in March 2019 for macular edema due to RVO (retinal vein occlusion). Safety and efficacy data for AR-1105 will be evaluated at six months after dosing."

P2 data

Evaluation of Incorporation Efficiency of Dexamethasone in a Polymer Matrix for Sustained Release Implant Manufacturing. (ARVO 2019) - "...The AR-1105 manufacturing process used to make sustained release, dexamethasone implants requires multiple steps to incorporate dexamethasone into a polymer matrix...Here we demonstrate control over the manufacturing process for dexamethasone intravitreal implants. The greatest loss of dexamethasone occurs after the initial mixing and extrusion of the material. Incorporation of dexamethasone in the polymer matrix was demonstrated throughout the manufacturing process and across multiple batches of two different formulations."

Aerie pharmaceuticals initiates phase 2 clinical trial of AR-1105 (dexamethasone intravitreal implant) in patients with macular edema associated with retinal vein occlusion (Businesswire) - "Aerie Pharmaceuticals...announced the commencement of patient dosing in a Phase 2 clinical trial of AR-1105, its investigational dexamethasone intravitreal implant, in patients with macular edema due to retinal vein occlusion...By the end of this quarter, we also plan to file an Investigational New Drug (IND) application for our second sustained delivery retina product, AR-13503 Implant...for the treatment of wet age-related macular degeneration and diabetic macular edema."

IND • Trial status

Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO) (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Aerie Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Aerie Pharmaceuticals announces acceptance of its Investigational New Drug application for AR-1105 (dexamethasone intravitreal implant) (Businesswire) - "Aerie Pharmaceuticals...today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug Application (IND) for AR-1105...and it is now in effect, allowing Aerie to initiate human studies in the treatment of macular edema due to retinal vein occlusion...Aerie expects to initiate a Phase 2 clinical study later in the first quarter of 2019...This quarter we also plan to file an IND for our second retina product...AR-13503 that is being developed for wet age-related macular degeneration and diabetic macular edema."

IND • New P2 trial