Price Target Changed • Nov 16
Price target decreased to US$16.88 Down from US$18.89, the current price target is an average from 6 analysts. New target price is 11% above last closing price of US$15.23. The company is forecast to post a net loss per share of US$2.33 next year compared to a net loss per share of US$1.61 last year. Reported Earnings • Nov 05
Third quarter 2022 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2022 results: US$0.56 loss per share (improved from US$0.86 loss in 3Q 2021). Revenue: US$36.1m (up 23% from 3Q 2021). Net loss: US$26.8m (loss narrowed 32% from 3Q 2021). Revenue exceeded analyst estimates by 2.4%. Earnings per share (EPS) missed analyst estimates by 5.9%. Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 4.0% growth forecast for the Pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 41% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings. Price Target Changed • Aug 24
Price target decreased to US$16.67 Down from US$18.78, the current price target is an average from 10 analysts. New target price is 9.8% above last closing price of US$15.18. The company is forecast to post a net loss per share of US$2.33 next year compared to a net loss per share of US$1.61 last year. Ankündigung • Aug 24
Alcon Inc. (SWX:ALC) entered into a definitive merger agreement to acquire Aerie Pharmaceuticals, Inc. (NasdaqGM:AERI) for approximately $770 million. Alcon Inc. (SWX:ALC) entered into a definitive merger agreement to acquire Aerie Pharmaceuticals, Inc. (NasdaqGM:AERI) for approximately $770 million on August 22, 2022. The purchase price of $15.25 per share represents a premium of 37% to Aerie’s last closing price and represents an equity value of approximately $770 million. Alcon intends to fund the acquisition through short-term and long-term debt. The transaction was approved by the board of directors of Alcon and Aerie. The transaction is anticipated to close in the fourth quarter of 2022, subject to the approval of Aerie’s stockholders and the satisfaction of customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act. The transaction is expected to be accretive to Alcon’s core diluted Earnings Per Share (EPS) in 2024. J.P. Morgan acted as Alcon’s financial advisor for the transaction, and Alcon’s legal advisor was Skadden, Arps, Slate, Meagher & Flom LLP. Goldman Sachs & Co. LLC acted as Aerie’s financial advisor for the transaction, and Aerie’s legal advisor was Fried, Frank, Harris, Shriver & Jacobson LLP. Major Estimate Revision • Aug 23
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$2.10 to -US$2.33 per share. Revenue forecast unchanged at US$137.5m. Pharmaceuticals industry in the US expected to see average net income decline 0.5% next year. Consensus price target down from US$19.74 to US$18.89. Share price rose 30% to US$15.16 over the past week. Major Estimate Revision • Aug 12
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$2.54 to -US$2.10 per share. Revenue forecast steady at US$136.9m. Pharmaceuticals industry in the US expected to see average net income decline 3.6% next year. Consensus price target broadly unchanged at US$18.78. Share price rose 30% to US$11.57 over the past week. Reported Earnings • Aug 05
Second quarter 2022 earnings: EPS and revenues exceed analyst expectations Second quarter 2022 results: US$0.41 loss per share (up from US$0.84 loss in 2Q 2021). Revenue: US$33.3m (up 23% from 2Q 2021). Net loss: US$19.4m (loss narrowed 50% from 2Q 2021). Revenue exceeded analyst estimates by 2.5%. Earnings per share (EPS) also surpassed analyst estimates by 38%. Over the next year, revenue is expected to shrink by 24% compared to a 18% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 28% per year, which means it is significantly lagging earnings. Ankündigung • Aug 02
Aerie Pharmaceuticals, Inc. Announces First Participant Dosed in the Comet-3 Study of Ar-15512 for the Treatment of Dry Eye Disease Aerie Pharmaceuticals, Inc. announced that the first participant has been dosed in the Phase 3 registrational “COMET-3” study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED). COMET-3 is the second of three trials in the Phase 3 registrational program for AR-15512. Aerie plans to initiate the last of the trials, the COMET-4 safety study, in the fourth quarter of 2022. Aerie intends to complete the AR-15512 registrational program in 2023 and, assuming clinical success, plans to file a New Drug Application (NDA) with the FDA in 2024. COMET-3 is a randomized, double-masked, vehicle-controlled, multi-center clinical study to evaluate the efficacy and safety of AR-15512, a TRPM8 agonist, in patients with DED. The study is expected to enroll approximately 460 participants at 20 U.S. sites and is identical in design to the COMET-2 study, which began enrolling in May 2022. Study participants will be randomized in a 1:1 ratio to receive either AR-15512 (0.003%) or AR-15512 vehicle as a drop dosed twice daily in each eye for three months. The primary efficacy assessment is tear production, as measured by the unanesthetized Schirmer’s Test (sign), and the key secondary measure is dry eye symptoms based on the Symptom Assessment iN Dry Eye (SANDE) questionnaire. Participants will be evaluated on multiple efficacy and safety assessments at multiple timepoints throughout the study. The AR-15512 Phase 3 registrational program is comprised of three studies, the COMET-2 and COMET-3 efficacy studies and the COMET-4 safety study, that will evaluate AR-15512 (0.003%) compared to AR-15512 vehicle in participants with DED. Enrollment is underway in COMET-2 and COMET-3, which are identical studies, and topline results are expected in the second half of 2023. COMET-4, which is expected to begin in the fourth quarter of 2022, is a 12-month safety study. Aerie will incorporate interim 6-month data from COMET-4 into the NDA filing for AR-15512, which is expected to be submitted in 2024. AR-15512 is a first-in-class TRPM8 agonist which acts as a cold thermoreceptor modulator to stimulate the cold sensing receptors found on the nerve endings that innervate the cornea and eyelids. By stimulating these receptors, AR-15512 leads to natural tear production and a cooling sensation across the surface of the eye that may result in a reduction in dry eye symptoms. Ankündigung • Jul 29
Aerie Pharmaceuticals, Inc. to Report Q2, 2022 Results on Aug 04, 2022 Aerie Pharmaceuticals, Inc. announced that they will report Q2, 2022 results After-Market on Aug 04, 2022 Ankündigung • May 26
Aerie Pharmaceuticals Announces First Participant Dosed in the Phase 3 Registrational COMET-2 Study of AR-15512 for the Treatment of Dry Eye Disease Aerie Pharmaceuticals, Inc. announced that the first participant has been dosed in the Phase 3 registrational “COMET-2” study to evaluate AR-15512 ophthalmic solution as a treatment for the signs and symptoms of dry eye disease (DED). COMET-2 is the first of three trials in the Phase 3 registrational program for AR-15512. Aerie plans to initiate the other two trials in the second half of 2022 in support of a potential New Drug Application (NDA) filing in 2024. COMET-2 is a randomized, double-masked, vehicle-controlled, multi-center clinical study to evaluate the efficacy and safety of AR-15512, a TRPM8 agonist, in patients with DED. The study is expected to enroll approximately 460 participants at 20 U.S. sites. Study participants will receive AR-15512 (0.003%) or AR-15512 vehicle as a drop dosed twice daily in each eye for three months. The primary efficacy assessment is tear production, as measured by the unanesthetized Schirmer test (sign), and the key secondary measure is dry eye symptoms based on the Symptom Assessment iN Dry Eye (SANDE) questionnaire. Participants will be evaluated on multiple efficacy and safety assessments at multiple timepoints throughout the study. Topline results from the COMET-2 study are expected in the second half of 2023. The AR-15512 Phase 3 registrational program is comprised of three studies, the COMET-2 and COMET-3 efficacy studies and the COMET-4 safety study, that will evaluate AR-15512 (0.003%) compared to AR-15512 vehicle in participants with DED. COMET-2, which is currently enrolling, and COMET-3, which is expected to begin in the third quarter of 2022, are identical studies with topline results expected in the second half of 2023. COMET-4, which is expected to begin in the fourth quarter of 2022, is a 12-month safety study. Aerie will incorporate interim 6-month data from COMET-4 into the NDA filing for AR-15512, which is expected to be submitted in 2024. AR-15512 is a first-in-class TRPM8 agonist which acts as a cold thermoreceptor modulator to stimulate the cold sensing receptors found on the nerve endings that innervate the cornea and eyelids. By stimulating these receptors, AR-15512 leads to natural tear production and a cooling sensation across the surface of the eye that may result in a reduction in dry eye symptoms. Dry eye disease affects about 30 million people in the U.S. It is estimated that about 60% of people with DED are diagnosed and less than 10% of patients are treated with prescription medications.1 Current treatment is comprised of over-the-counter “artificial tears” and prescription anti-inflammatories and nasal tear stimulants. The COMET-1 study evaluated two doses of AR-15512 compared to AR-15512 vehicle in 369 participants with DED. As reported in September 2021, the trial did not achieve Aerie’s previously chosen primary endpoints. The study showed a statistically significant, dose-dependent increase in tear production, a validated endpoint acceptable for registration of a product. In addition, AR-15512 demonstrated improvements on multiple validated sign, symptom, and quality of life endpoints across multiple timepoints. Importantly, the study showed that differences between AR-15512 and vehicle responses increased over time, indicating a potential sustained, meaningful treatment effect in DED signs and symptoms. COMET-1 demonstrated a favorable tolerability profile with no systemic or serious adverse events attributed to AR-15512. AR-15512 is a development stage product candidate and is not approved by any regulatory agency. Reported Earnings • May 06
First quarter 2022 earnings: EPS misses analyst expectations First quarter 2022 results: US$0.76 loss per share (up from US$0.91 loss in 1Q 2021). Revenue: US$29.8m (up 30% from 1Q 2021). Net loss: US$35.9m (loss narrowed 14% from 1Q 2021). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 5.7%. Over the next year, revenue is expected to shrink by 26% compared to a 7.6% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has increased by 28% per year but the company’s share price has fallen by 47% per year, which means it is significantly lagging earnings. Breakeven Date Change • Apr 27
No longer forecast to breakeven The 8 analysts covering Aerie Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$20.4m in 2024. New consensus forecast suggests the company will make a loss of US$25.4m in 2024. Price Target Changed • Apr 27
Price target decreased to US$18.88 Down from US$22.78, the current price target is an average from 8 analysts. New target price is 156% above last closing price of US$7.37. Stock is down 58% over the past year. The company is forecast to post a net loss per share of US$2.67 next year compared to a net loss per share of US$1.61 last year. Ankündigung • Apr 27
Dr. Gerald D. Cagle to Not Stand for Re-Election as Director of Aerie Pharmaceuticals, Inc Aerie Pharmaceuticals, Inc.'s Board has determined that Dr. Gerald D. Cagle will not stand for re-election at the Annual Meeting and that effective immediately prior to the Annual Meeting Dr. Cagle will retire as a member of the Board upon the conclusion of his current term. Ankündigung • Mar 07
Aerie Pharmaceuticals, Inc. Announces Retirement of Kathleen McGinley as Chief Human Resources Officer and Vice President, Corporate Services, Effective March 31, 2022 On March 1, 2022, Kathleen McGinley, the Chief Human Resources Officer and Vice President, Corporate Services of Aerie Pharmaceuticals, Inc., provided notice to the company of her intent to retire from her roles at the Company. Ms. McGinley’s resignation will be effective March 31, 2022 and until that time, among her regular duties, she will assist with an orderly transition of her responsibilities. Ankündigung • Mar 04
Aerie Pharmaceuticals, Inc. Announces Executive Changes On March 2, 2022, Aerie Pharmaceuticals, Inc. announced that, effective as of March 1, 2022, Benjamin F. McGraw, III, Pharm.D. will conclude his role as Interim Executive Chair of the Board of Directors of the Company and in connection therewith will no longer serve as the Company’s principal financial officer. On the Effective Date, Dr. McGraw, Chair of the Board, will resume his status as an independent director. Also on the Effective Date, the Board designated Raj Kannan, the Company’s Chief Executive Officer, to serve as the Company’s principal financial officer, succeeding Dr. McGraw in such capacity, effective as of the Effective Date. Mr. Kannan will serve in the role of principal financial officer until such time as the Company appoints a new Chief Financial Officer. Reported Earnings • Feb 26
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: US$1.61 loss per share (up from US$3.99 loss in FY 2020). Revenue: US$194.1m (up 134% from FY 2020). Net loss: US$74.8m (loss narrowed 59% from FY 2020). Revenue exceeded analyst estimates by 75%. Earnings per share (EPS) missed analyst estimates by 51%. Over the next year, revenue is expected to shrink by 28% compared to a 21% growth forecast for the pharmaceuticals industry in the US. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 46% per year, which means it is significantly lagging earnings. Breakeven Date Change • Feb 26
No longer forecast to breakeven The 9 analysts covering Aerie Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$20.4m in 2024. New consensus forecast suggests the company will make a loss of US$25.4m in 2024. Ankündigung • Feb 18
Aerie Pharmaceuticals, Inc. to Report Q4, 2021 Results on Feb 24, 2022 Aerie Pharmaceuticals, Inc. announced that they will report Q4, 2021 results After-Market on Feb 24, 2022 Breakeven Date Change • Jan 01
Forecast to breakeven in 2024 The 8 analysts covering Aerie Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$34.9m in 2024. Average annual earnings growth of 61% is required to achieve expected profit on schedule. Board Change • Dec 05
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 5 experienced directors. 1 highly experienced director. Independent Director Peter McDonnell was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Nov 06
Third quarter 2021 earnings released: US$0.86 loss per share (vs US$0.86 loss in 3Q 2020) The company reported a solid third quarter result with improved revenues and control over costs, although losses were not reduced. Third quarter 2021 results: Revenue: US$29.3m (up 46% from 3Q 2020). Net loss: US$39.7m (flat on 3Q 2020). Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. Price Target Changed • Nov 06
Price target decreased to US$25.00 Down from US$27.27, the current price target is an average from 12 analysts. New target price is 104% above last closing price of US$12.24. Stock is up 16% over the past year. The company is forecast to post a net loss per share of US$3.04 next year compared to a net loss per share of US$3.99 last year. Reported Earnings • Aug 06
Second quarter 2021 earnings released: US$0.84 loss per share (vs US$1.05 loss in 2Q 2020) The company reported a solid second quarter result with reduced losses, improved revenues and improved control over expenses. Second quarter 2021 results: Revenue: US$27.2m (up 51% from 2Q 2020). Net loss: US$38.7m (loss narrowed 20% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 15% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings. Executive Departure • Aug 04
CFO, Secretary & Treasurer Richard Rubino has left the company During their tenure, earnings grew by 25% annually compared to the industry average of 14%. As of March 2021, Richard still personally held 353.94k shares (US$6.3m worth at the time). Richard is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 3.04 years. Breakeven Date Change • May 25
Forecast to breakeven in 2024 The 12 analysts covering Aerie Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$15.2m in 2024. Average annual earnings growth of 58% is required to achieve expected profit on schedule. Is New 90 Day High Low • Feb 27
New 90-day high: US$18.39 The company is up 41% from its price of US$13.00 on 27 November 2020. The American market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$181 per share. Reported Earnings • Feb 27
Full year 2020 earnings released: US$3.99 loss per share (vs US$4.39 loss in FY 2019) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: US$83.1m (up 19% from FY 2019). Net loss: US$183.1m (loss narrowed 8.3% from FY 2019). Over the last 3 years on average, earnings per share has increased by 6% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Feb 27
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 3.3%. Earnings per share (EPS) also surpassed analyst estimates by 4.9%. Over the next year, revenue is forecast to grow 40%, compared to a 28% growth forecast for the Pharmaceuticals industry in the US. Ankündigung • Feb 19
Aerie Pharmaceuticals, Inc. to Report Q4, 2020 Results on Feb 25, 2021 Aerie Pharmaceuticals, Inc. announced that they will report Q4, 2020 results After-Market on Feb 25, 2021 Is New 90 Day High Low • Jan 20
New 90-day high: US$15.07 The company is up 65% from its price of US$9.15 on 21 October 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$171 per share. Ankündigung • Jan 12
Aerie Pharmaceuticals Receives European Commission Approval for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Aerie Pharmaceuticals, Inc. announced the European Commission (EC) has granted a marketing authorisation for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction. The marketing authorisation application (MAA) for Roclanda® was accepted for review by the European Medicines Agency (EMA) in January 2020. Aerie received a positive scientific opinion recommending approval of the Roclanda® MAA from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in November 2020. Roclanda® was approved by the U.S. Food and Drug Administration (FDA) in March 2019 under the trade name Rocklatan® for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Rhokiinsa® was granted a marketing authorisation by the EC in November 2019 for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension. Rhokiinsa® was approved by the FDA in December 2017 under the trade name Rhopressa® for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The marketing authorisation is valid in all 27 countries of the European Union, plus Iceland, Norway and Liechtenstein. As the EC decision was received after the end of the Brexit transition period, Aerie will complete a further administrative step in order to obtain a license in the United Kingdom. No reexamination of clinical data by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is expected. Is New 90 Day High Low • Dec 19
New 90-day high: US$13.18 The company is up 8.0% from its price of US$12.20 on 18 September 2020. The American market is up 15% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Pharmaceuticals industry, which is up 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$167 per share. Ankündigung • Nov 14
Aerie Pharmaceuticals, Inc. Receives Positive CHMP Opinion for Roclanda® in the European Union Aerie Pharmaceuticals, Inc. announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. The recommended indication is the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction. The CHMP positive opinion is a scientific recommendation for marketing authorisation, which is referred to the European Commission for a final decision on the Company’s MAA. The final decision is expected in approximately two months and will be applicable to all European Union member states plus Iceland, Norway and Liechtenstein. Is New 90 Day High Low • Nov 12
New 90-day high: US$13.05 The company is up 3.0% from its price of US$12.71 on 14 August 2020. The American market is up 6.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Pharmaceuticals industry, which is flat over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$145 per share. Analyst Estimate Surprise Post Earnings • Nov 08
Revenue beats expectations, earnings disappoint Revenue exceeded analyst estimates by 2.7%. Earnings per share (EPS) missed analyst estimates by 8.1%. Over the next year, revenue is forecast to grow 34%, compared to a 30% growth forecast for the Pharmaceuticals industry in the US. Reported Earnings • Nov 08
Third quarter 2020 earnings released: US$0.86 loss per share The company reported a solid third quarter result with reduced losses and improved revenues and control over expenses. Third quarter 2020 results: Revenue: US$20.1m (up 8.3% from 3Q 2019). Net loss: US$39.6m (loss narrowed 20% from 3Q 2019). Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 45% per year, which means it is performing significantly worse than earnings. Ankündigung • Oct 30
Aerie Pharmaceuticals, Inc. Announces Commencement of Comet-1 Aerie Pharmaceuticals, Inc. announced the commencement of COMET-1, a Phase 2b clinical trial of AR-15512 (TRPM8 agonist) ophthalmic solution for the treatment of patients with dry eye disease. The COMET-1 trial is a randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of AR-15512 (TRPM8 agonist) in patients with dry eye disease. Approximately 360 patients in total are expected to be enrolled. Patients will receive either AR-15512 0.0014%, AR-15512 0.003% or AR-15512 vehicle dosed as one drop twice daily in each eye over three months. The primary efficacy endpoints of the clinical trial are ocular discomfort (symptom) and tear production (sign). Patients will be evaluated on multiple efficacy assessments at days 14, 28 and 84; safety will be assessed at all visits. Topline results from COMET-1 are expected in the third quarter of 2021. Ankündigung • Oct 28
Aerie Pharmaceuticals, Inc. to Report Q3, 2020 Results on Nov 05, 2020 Aerie Pharmaceuticals, Inc. announced that they will report Q3, 2020 results on Nov 05, 2020 Is New 90 Day High Low • Oct 20
New 90-day low: US$9.92 The company is down 25% from its price of US$13.26 on 22 July 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is flat over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$131 per share. Ankündigung • Sep 30
Aerie Pharmaceuticals Announces Acceptance of Its Investigational New Drug Application for AR-15512 (TRPM8 Agonist) Eye Drop for Dry Eye Disease Aerie Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug Application (IND) for AR-15512 (TRPM8 agonist) eye drop for dry eye and it is now in effect, allowing Aerie to initiate clinical studies in the treatment of dry eye. Aerie expects to initiate a Phase 2b clinical study in the fourth quarter of 2020. AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 in the acquisition of Avizorex Pharma, S.L., a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease. The active ingredient in AR-15512 is a potent and selective agonist of the TRPM8 cold thermoreceptor ion channel that regulates tear production and blink rate. By stimulating these processes, TRPM8 agonists have the potential to restore tear film volume and reduce ocular discomfort in patients with dry eye. Avizorex completed a Phase 2a study in dry eye subjects in 2019 where positive results support the therapeutic potential to treat signs and symptoms of dry eye. Ankündigung • Sep 26
Aerie Pharmaceuticals, Inc. Announces Successful Interim 90-Day Topline Data from Its Six-Month Phase 3B Clinical Trial in Europe Known as Mercury 3 Aerie Pharmaceuticals, Inc. announced successful interim 90-day topline data from its six-month Phase 3b clinical trial in Europe known as Mercury 3, comparing Roclanda ® to Ganfort®. Roclanda ® is marketed in the United States as Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. Ganfort ® is approved for use in Europe but is not approved for use in the United States. Mercury 3 was designed as a non-inferiority trial to compare intraocular pressure (IOP) reduction in patients with open-angle glaucoma or ocular hypertension. Roclanda® met the overall trial objective by demonstrating non-inferiority to Ganfort® across nine of nine timepoints over 90 days. Roclanda® demonstrated consistent IOP reduction throughout the day of approximately 9.5 millimeters of mercury (mmHg) for an average reduction from baseline IOPs of approximately 37 percent. The IOP reductions observed in Mercury 3 exceeded those from both Mercury 1 and Mercury 2. The IOP reduction results for Roclanda® were highly consistent with those of Ganfort®. Incidence of ocular adverse events for Roclanda® were lower than observed in Mercury 1 and Mercury 2. Six-month topline results are expected by early 2021. Mercury 3 was designed as a non-inferiority trial to compare intraocular pressure (IOP) reduction in patients with open angle glaucoma or ocular hypertension. Approximately 430 subjects satisfying inclusion criteria were randomized to one of two arms and received masked study medication once-daily in the evening. The Mercury 3 clinical trial included Roclanda®, which in the United States is marketed as Rocklatan ® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% and represents a fixed-dose combination of Rhopressa® (netarsudil ophthalmic solution) 0.02% and prostaglandin analog latanoprost. Ganfort® represented the comparator, a fixed-dose combination of prostaglandin analog Lumigan ® and beta blocker timolol. Rocklatan® is the only fixed-dose combination product commercially available in the United States that includes a prostaglandin analog. The Ganfort® fixed-dose combination includes a prostaglandin analog and a beta blocker, and while it is approved for use in Europe, it is not approved for use in the United States. Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a once-daily eye drop that is a fixed-dose combination of latanoprost, the most widely-prescribed prostaglandin analog (PGA), and netarsudil, the active ingredient in Rhopressa ® (netarsudil ophthalmic solution) 0.02%, a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork (the eye’s principal drainage pathway). The diseased trabecular meshwork is considered to be the main cause of elevated intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. Rhopressa ® works by restoring outflow through the trabecular meshwork, while latanoprost increases fluid outflow through a secondary mechanism known as the uveoscleral pathway. In clinical trials of Rocklatan®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. 