AbbVie, Inc.

Phase 2 data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p<0.0001) through six months, with clinically meaningful reductions of 24-30% achieved with a single PAXTRAVA implant Generally well tolerated with no impact on corneal health observed Consistent durability of IOP reduction and implant bioresorption shows potential for repeat dosing without stacking of implants Expanded Focus on Retinal Disease Highlighted at the April 4th Eyecelerator BEDFORD, Mass., April 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced positive Phase 2 data for PAXTRAVA (travoprost intracameral implant or OTX-TIC) in patients with open-angle glaucoma or ocular hypertension (reported together as “glaucoma”, below) The data are being presented by Mark Gallardo, MD during the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. “Ocular is very pleased to report positive six-month topline results for PAXTRAVA in the Phase 2 glaucoma study. We designed the Phase 2 clinical trial to evaluate PAXTRAVA over several time points that we believe are clinically meaningful, through six months. Observation of IOP reduction as early as the first follow-up visit, at 2 weeks, and demonstration of a 24-30% reduction in mean IOP through six months, with consistent and sustained reductions at each and every timepoint, are at the core of our enthusiasm for these results. That the majority of eyes (81.3%) treated with PAXTRAVA did not require additional IOP lowering therapy through six months further supports the strength of the data,” said Rabia Gurses Ozden, MD, Chief Medical Officer at Ocular Therapeutix. “As we incorporate these efficacy data, coupled with the expanded safety database, into our evaluation of next steps for the program, we thank all of the patients, caregivers and study sites who participated in this Phase 2 study.” Summary of Data and Findings: Efficacy: PAXTRAVA 26 µg single implant demonstrated consistent IOP control through 6 months: Statistically significant IOP changes from baseline were observed for each and every individual and mean diurnal measurement at Week 2 (M0.5), Week 6 (M1.5), and Week 12 (M3), as well as Months 4.5 and 6 (p<0.0001), although no formal statistical testing was prespecifiedClinically meaningful mean IOP reduction of ~24-30% from baseline observed over six monthsA majority (81.3%) of treated eyes did not require additional IOP-lowering therapy through 6 months indicating sustained and consistent treatment effects Safety: PAXTRAVA 26 µg was generally well-tolerated No impact on corneal endothelium was observed at 6 months following a single administrationMajority of adverse events (AEs) were mild in severity and generally resolved with topical medical treatment. Most ocular AEs within 3 days were deemed related to the injection procedure by the investigators. Post injection AEs observed (>3 days post injection procedure) were consistent with the travoprost label. One implant required removal (classified as a serious adverse event), most likely due to a peri-implantation bacterial infection, per investigatorConsistent bioresorption of the implant coupled with the durable effect seen in the trial suggests redosing would be possible, without the risk of stacking implants “I have dedicated my career to taking care of people with glaucoma and the evaluation of new therapies. I am enthusiastic about PAXTRAVA because of the positive, durable IOP reductions, accompanied by a good overall safety profile,” said Mark Gallardo, MD. Dr. Gallardo is a Study Investigator and Glaucoma Specialist at El Paso Eye Surgeons. He is an active principal investigator of innovative new treatments, having participated in more than 20 clinical trials over the last 7 years. “We were pleased to observe that PAXTRAVA generally stays in place at the site of implantation and maintains its form, that the majority of implants (64.5%) were significantly or fully bioresorbed at six months and that the implants were not observed to impact the surrounding corneal endothelium. Together, these features could address the compliance challenge of daily eyedrops and enable repeat dosing, without the risk of stacking, critical for the treatment of chronic disease. The totality of these features makes me optimistic about this product candidate.” The complete presentation (Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: Results from a Phase 2 Clinical Trial) will be available in the Scientific and Medical presentations section of the Company’s investor website. Phase 2 Study Overview: The PAXTRAVA Phase 2 study was designed as a randomized, parallel-group, controlled study to evaluate the safety and efficacy of PAXTRAVA in subjects with open-angle glaucoma (“OAG”) or ocular hypertension (“OHT”) and reported together as “glaucoma”, per above. Following a standard medication wash-out, patients were randomized 1:1:1 into one of three dosing groups (5 µg or 26 µg of PAXTRAVA or DURYSTA® (bimatoprost implant)), dosed in ‘the study eye’ and followed for frequent assessments through the six month analysis point. Due to elevations in IOP observed in seven out of the 16 subjects enrolled in the PAXTRAVA 5 μg arm of the trial, the Company closed enrollment in this arm and continued with the PAXTRAVA 26 μg and DURYSTA arms of the trial. Safety and efficacy data presented at ASCRS and reported in this press release are based on the 26 µg dosing group, as a result. The enrolled subjects had a mean age of 65 years and had been previously treated with a mean of about 1.2 IOP-lowering agents prior to study entry. The treatment groups were well balanced for key demographics and baseline characteristics. The primary efficacy endpoints included measurement of changes in intraocular pressure (IOP) at three diurnal measurements (8 AM, 10AM and 4 PM) at weeks 2, 6, 12 and secondary endpoints included measurements at all other visits including 4.5 and 6 months. No formal statistical testing was prespecified in the clinical trial protocol or the statistical analysis plan. Other assessments included an evaluation of the need for additional IOP-lowering therapy, changes in endothelial count and central corneal thickness, as well as an evaluation of safety for the period. Summary of next steps: Seek an end-of-Phase 2 meeting with the FDA to finalize development plans for PAXTRAVA Phase 3 trials and move to a next generation, commercial injector that eases initiation of therapy. Strategic Focus on Retinal Disease Highlighted at the April 4th Eyecelerator@ASCRS Conference On Thursday, April 4th, Pravin Dugel, MD, Executive Chairman of Ocular Therapeutix presented at the Eyecelerator@ASCRS conference. “Ocular was very pleased to connect with the Eyecelerator community to share more about our strategic vision for Ocular as we transition to a retina-focused company”, said Dr. Dugel. “There are three important pillars related to our Phase 3 program for AXPAXLI™ for wet Age-related Macular Degeneration (wet AMD) that support our transformation to a leading retina company: promising clinical data, de-risking regulatory pathway, and an expansive market opportunity. With our expanded strategic and clinical team of recognized experts in place to strengthen the Company’s retinal expertise, I believe we are on a solid path to enrich and accelerate the AXPAXLI clinical program.” The complete presentation (Ocular Therapeutix, Evolving into a leading retina company) will be available in the Events and Presentations section of the Company’s investor website. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye. AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in the first of two planned pivotal Phase 3 trials for wet AMD, the SOL-1 trial, and a Phase 1 clinical trial for the treatment of non-proliferative diabetic retinopathy. The clinical portfolio also includes PAXTRAVA™ (travoprost intracameral implant, also known as OTX-TIC), currently in a Phase 2 clinical trial for the treatment of primary open-angle glaucoma or ocular hypertension. Ocular’s expertise in the formulation, development and commercialization of innovative therapies and the ELUTYX platform supported the development and launch of its first commercial drug product, DEXTENZA®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. ELUTYX is also the foundation for two other clinical-stage assets, OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease and OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease, as well as several preclinical programs. Follow us on our website, LinkedIn or X. DEXTENZA® is a registered trademark of Ocular Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, and ELUTYX™ and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. DURYSTA® is a registered trademark of Allergan, an AbbVie company. The travoprost label can be referenced using the accessdata.fda.gov site About DEXTENZA DEXTENZA is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis. DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus, and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. DEXTENZA resorbs and exits the nasolacrimal system without the need for removal. Please see full Prescribing and Safety Information at the DEXTENZA website. Forward-Looking Statements: Any statements in this press release about future expectations, plans, and prospects for the Company, including the development and regulatory status of the Company’s product candidates, including the timing, design, and enrollment of the Company’s pivotal trials of AXPAXLI (also called OTX-TKI) for the treatment of wet AMD; the Company’s plans to advance the development of AXPAXLI, PAXTRAVA and its other product candidates; the size of potential markets for its product candidates; the potential utility of any of the Company’s product candidates; the sufficiency of the Company’s cash resources; and other statements containing the words "anticipate”, "believe”, "estimate”, "expect”, "intend", "goal”, "may", "might”, "plan”, "predict”, "project”, "target”, "potential”, "will”, "would”, "could”, "should”, "continue”, and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the timing and costs involved in commercializing DEXTENZA or any product or product candidate that receives regulatory approval; the ability to retain regulatory approval of DEXTENZA or any product or product candidate that receives regulatory approval; the initiation, design, timing, conduct and outcomes of clinical trials, including the SOL-1 trial, the planned SOL-2 trial and the Company’s other ongoing clinical trials; the risk that the FDA will not agree with the Company’s interpretation of the written agreement under Special Protocol Assessment for the SOL-1 trial; the risk that even though the FDA has agreed with the overall design of the SOL-1 trial, the FDA may not agree that the data generated by the SOL-1 trial supports potential marketing approval; uncertainty as to whether the data from earlier clinical trials will be predictive of the data of later clinical trials, particularly later clinical trials that have a different design or utilize a different formulation than the earlier trials; availability of data from clinical trials and expectations for regulatory submissions and approvals; the Company’s scientific approach and general development progress; uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials; the Company’s existing indebtedness and the ability of the Company’s creditors to accelerate the maturity of such indebtedness upon the occurrence of certain events of default; the Company’s ability to enter into strategic alliances or generate additional funding on a timely basis, on favorable terms, or at all; and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this press release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. InvestorsOcular Therapeutix, Inc.Donald NotmanChief Financial Officerdnotman@ocutx.com Joyce AllaireLifeSci Advisorsjallaire@lifesciadvisors.com

Total spending for March was $188 million, up from $168.4 million in February. This is still some way off the $200 million-plus we saw tallied up for most months toward the end of 2023. It’s as you were at the top of the pharma drug ad spending list in March as AbbVie’s immunology blockbusters Rinvoq and Skyrizi stay first and second, respectively. This is the same order as we saw in February, according to data from real-time ad trackers at iSpot.TV, with spending also barely moving across both drugs and their spots. However, the third position saw a significant shift. This spot is usually reserved for Sanofi and Regeneron’s rival immunology giant Dupixent, but, in March, Otsuka and Lundbeck's Rexulti took its place. After spending just under $11 million in February and not being listed, Rexulti ads jumped right into the final podium position in March as the pair spent $24.8 million on three spots. Bristol Myers Squibb’s moderate to severe plaque psoriasis drug Sotyktu also jumped into the top 10 after not being in the listing at all the month before, more than doubling spending from $8.6 million in February to $19 million in March. Dupixent has dropped down to fifth place from its usual ranking, while Merck's Gardasil HPV vaccine has made an unexpected appearance at No. 6 on the list of ad spending. Gardasil's ad spending saw a major boost from $7,600 to $14.7 million month over month. In seventh place is Astellas’ hot flash treatment Veozah, down three places, while BMS makes its second entry into the top 10 with its skin, lung and many other cancers immunotherapy Opdivo. Opdivo has over time been in these top 10 lists—but never consistently—and it remains unusual to see any cancer med in these listings, given that it’s not a general drug for common conditions like psoriasis or asthma. BMS was, however, clearly feeling flush as it also splashed out $14 million on ads for a third drug, namely its obstructive hypertrophic cardiomyopathy treatment Camzyos. Rounding off the top 10 is UCB’s moderate to severe plaque psoriasis therapy Bimzelx, which saw exactly $0 spent in February and rose to $13.6 million in March, as it launched its first DTC campaign in time for the Oscars. Total spending for March was $188 million, up from $168.4 million in February. This is still some way off the $200 million-plus we saw tallied up for most months toward the end of 2023, but still a strong showing so early in the year, when overall spending numbers tend to be lower.   Check out the top 10 pharmaceutical drug ad spenders as compiled for Fierce Pharma Marketing by iSpot.TV below.     1. Rinvoq Movement: No change What is it? AbbVie’s JAK inhibitor immunology drug Est. national TV ad spend: $31 million (up from $30.1 million in February) Number of spots: Six (one eczema, two arthritis, three UC/Crohn’s) Biggest-ticket ad: “Mountains” (est. $8.6 million)   2. Skyrizi Movement: No change What is it? AbbVie’s immunology drug Est. national TV ad spend: $24.8 million (down from $24.9 million in February) Number of spots: Eight (four psoriasis, one Crohn’s, three psoriatic arthritis) Biggest-ticket ad: “Sailing” (est. $12.5 million)   3. Rexulti Movement: Not listed last month What is it? Otsuka and Lundbeck’s atypical antipsychotic Est. national TV ad spend: $23.4 million (up from $10.8 million in February) Number of spots: Three (two Alzheimer’s, one depression) Biggest-ticket ad: “Still Masking” (est. $18.8 million)   4. Sotyktu Movement: Not listed last month What is it? Bristol Myers Squibb’s moderate to severe plaque psoriasis drug Est. national TV ad spend: $19 million (up from $8.6 million in February) Number of spots: Three Biggest-ticket ad: “Live Unfiltered” (est. $16 million)   5. Dupixent Movement: Down two spots What is it? Sanofi and Regeneron’s immunology drug. Est. national TV ad spend: $18.7 million (down from $20.3 million in February) Number of spots: Seven (three eczema, three asthma, one gastrointestinal) Biggest-ticket ad: “DU More: Diving Board, Soccer and Playground” (est. $7.7 million)   6. Gardasil Movement: Not listed last month What is it? Merck's HPV vaccine Est. national TV ad spend: $14.7 million (up from $7.6K in February) Number of spots: One Biggest-ticket ad: “Numbers Move You” (est. $14.7 million)   7. Veozah Movement: Down three spots What is it? Astellas’ hot flash treatment Est. national TV ad spend: $14.4 million (down from $16.2 million in February) Number of spots: One Biggest-ticket ad: “Not Flash” (est. $14.4 million)   8. Opdivo Movement: Up one spot What is it? Bristol Myers Squibb’s cancer medicine Est. national TV ad spend: $14.4 million (up from $11.3 million in February) Number of spots: One Biggest-ticket ad: “Advanced Lung Cancer” (est. $14.4 million)   9. Camzyos Movement: Down four spots What is it? Bristol Myers Squibb’s symptomatic obstructive hypertrophic cardiomyopathy treatment Est. national TV ad spend: $14 million (down from $16 million in February) Number of spots: Two Biggest-ticket ad: “Mike” (est. $7.9 million)   10. Bimzelx Movement: Not listed last month What is it? UCB’s moderate to severe plaque psoriasis therapy Est. national TV ad spend: $13.6 million (up from $0 in February) Number of spots: Three Biggest-ticket ad: “Born With Wings” (est. $12 million)

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Lonza nabs new CEO after snapping up Roche site Lonza From one Swiss CDMO to another. That’s the course Wolfgang Wienand is taking, with summer plans to jump from his role at Siegfried’s helm over to lead Lonza.  Lonza’s interim CEO Albert Baehny, who stepped up from his chair position in October after Pierre-Alain Ruffieux abruptly left, is set to retire from the CDMO giant after a transition period. The interim leader is expected to cede his chair title to Heineken Chair Jean-Marc Huët at Lonza’s annual shareholder meeting this May. Newly tapped Wienand will join Lonza after serving as Siegfried’s CEO for five years. He joined the CDMO in 2010 and held a variety of leadership roles before taking up the top spot, including chief scientific officer, head of global R&D and chief strategy officer.  The CEO announcement follows years of leadership turnover at Lonza and comes a few weeks after the CDMO unveiled a $1.2 billion acquisition of a large biologics manufacturing facility in California from Roche’s Genentech. Fierce Pharma  Amgen R&D leader jumps to Acadia Acadia Pharmaceuticals After leading R&D at Horizon Therapeutics, and then Amgen after Horizon’s $27.8 billion acquisition, Elizabeth H. Z. Thompson, Ph.D., is heading over to neuroscience-focused Acadia Pharmaceuticals.  Thompson is taking on the role of EVP and head of R&D at Acadia, which touts the only FDA-approved drug to treat hallucinations and delusions tied to Parkinson’s disease psychosis as well as the only FDA-approved drug for treating Rett syndrome. Thompson will focus on Acardia’s clinical-stage programs, which include a candidate for a genetic disorder called Prader-Willi syndrome and an Alzheimer’s disease psychosis program. Thompson joins from Amgen, where she was EVP of rare disease R&D after the October acquisition of Horizon, where Thompson led R&D activities. Years ago, from 2003 to 2014, Thompson had started her biopharma career at Amgen before going on to hold roles across AbbVie, Raptor and InterMune. Release  3 C-suite leaders depart I-Mab I-Mab I-Mab’s chief business officer Weimin Tang, chief communications officer Gigi Qi Feng and chief legal officer Richard Cheng Li have all chosen to exit the oncology biotech. The departures aren’t due to any disagreement with the company, according to a Securities and Exchange Commission filing, with all three leaders leaving to pursue other opportunities.  Lan Kang, a director of I-Mab’s board, has also resigned, citing personal reasons. Of late, the company has taken steps toward becoming a U.S.-focused biotech, beginning the process of divesting its China operations in February. I-Mab did not return Fierce Biotech’s request for comment as of the time of publication. Release  > Julie Clauss is joining Odyssey Therapeutics’ adventure as chief operating officer, the company announced this week. Joining her is Christopher Butler, who was named SVP and head of chemistry. Release  > Mosaic is painting an updated R&D future with two new hires. The biotech has named Malavi Madireddi, Ph.D., as SVP of drug discovery and Scott Glaser, Ph.D., as SVP of biologics discovery. Release  > Margaret Garin, M.D., has been named VP of clinical development at Trevi Therapeutics after working on the clinical development team at now-GSK-owned Bellus Health. Former Bellus CEO Roberto Bellini took to LinkedIn last month to advocate for his former employees following layoffs at the bought biotech. Release  > NewAmsterdam Pharma has appointed Juliette Audet to serve as the company’s chief business officer. Audet was most recently a partner at life sciences VC Forbion, where she helped build NewAmsterdam Pharma. “She was very instrumental in our founding—she and I worked together on the first financing, the series A, and has been very involved in the strategy for the company formation,” NewAmsterdam CEO Michael Davidson, M.D., told Fierce Biotech this week. “So it's exciting to see her with her talent and experience actually join the leadership team now.” Release > Zura Bio has tapped Robert Lisicki to replace founding CEO Someit Sidhu, M.D., who will stay on as a non-independent board director. Lisicki most recently worked a brief six-month stint as CEO of InCarda Therapeutics. Release  > After overseeing regulatory development at Samsung Bioepis, Luke Oh, Ph.D., is set to join NeoImmuneTech as CEO. Oh worked at the FDA prior to his executive position at Samsung. Release  > Ratio Therapeutics has called on Bill Cupelo to be chief business officer after he led the sales team at Invicro. The company also announced that D. Scott Holbrook would join its board of directors. Release  > Dutch biotech Prilenia Therapeutics has hired Jina Swartz, M.D., Ph.D., as its chief medical officer. She previously held the same role at fellow neurodegenerative-focused company, Exciva. Release  > CDMO KBI Biopharma is bringing aboard Peter Carbone as chief quality officer. He joins from the Center for Breakthrough Medicines, another CDMO where he was chief operating officer. Fierce Pharma > Former CEO of Seeker Biologics, Rand Sutherland, M.D., has been named the new CEO of Upstream Bio. The company also brought on Mike Gray as CFO and COO in addition to Lisa Fiering as SVP of people and culture. Release > Addex CEO Tim Dyer will lead a new spinout company, Neurosterix, according to an announcement this week. He has been at Addex for more than 20 years. Release > Ex-Heron Therapeutics CMO Chris Storgard, M.D., has been named chief medical officer of ADARx. Before that, he was the CMO of Fate Therapeutics. Release > Merck & Co. has a new head of human resources, naming Betty Larson for the job, according to an emailed press release. She most recently was chief people officer at GE HealthCare.  > It’s difficult to fully understand the human impact of biopharma layoffs, but Fierce Biotech calculated at least 2,398 people laid off from the 25 companies reporting numbers of employees affected for 2024’s first quarter. In total, 58 layoff rounds were recorded for the industry from January through March. Fierce Biotech