A Randomized, Controlled, Subject- and Evaluator-Masked, Phase 2 Clinical Trial Comparing EC-104 Intravitreal Implant to Ozurdex® for the Treatment of Diabetic Macular Edema (BETTIS-1)

This is a prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide [FA] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).

Start Date19 Aug 2024

Sponsor / Collaborator

Eclipse Life Sciences, Inc.

NCT05592717

/ RecruitingNot ApplicableIIT

An Observational Study of YUTIQ (Fluocinolone Acetonide Intravitreal Implant 0.18 mg) for the Management of Chronic Non-infectious Uveitis

This project is designed to evaluate the efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious uveitis.

Start Date05 Jan 2023

Sponsor / Collaborator

Tianjin Medical University

NCT05486468

/ Unknown statusPhase 3IIT

The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)

The Use of Two YUTIQ versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment (TYNI Trial)

Start Date05 Oct 2022

Sponsor / Collaborator

Texas Retina Associates

100 Clinical Results associated with Fluocinolone acetonide micro-insert intravitreous implant

100 Translational Medicine associated with Fluocinolone acetonide micro-insert intravitreous implant

100 Patents (Medical) associated with Fluocinolone acetonide micro-insert intravitreous implant

414

Literatures (Medical) associated with Fluocinolone acetonide micro-insert intravitreous implant

07 Jan 2025·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

Intravitreal Sustained Release Steroid Implants Are Safe and Effective in Patients With Glaucoma Drainage Devices

Article

Author: Hoyek, Sandra ; Lu, Edward S ; Lin, Michael M. ; Miller, John B. ; Tandias, Rachel ; Zhou, Henry W. ; Patel, Nimesh A. ; Solá-Del Valle, David

Purpose::

To describe effects of sustained-release steroid delivery devices on intraocular pressure (IOP) in eyes with glaucoma drainage devices (GDD).

Methods::

Retrospective case series of eyes with steroid implants (dexamethasone or fluocinolone acetonide) and prior GDD (Ahmed, Baerveldt) without uveitis. Outcomes included IOP, IOP rise, central foveal thickness (CFT), and IOP medications.

Results::

We included 14 eyes (14 patients, 38% male, 94% pseudophakic). Mean age at steroid implantation was 64 ± 12 years. Baerveldt (64%) was more common than Ahmed (36%). Tubes were in the anterior chamber (57.1%), sulcus (28.6%), and pars plana (14.3%). Ozurdex (93%) was more common than Yutiq (7%). Mean IOP was 13.5 ± 3.4 mmHg pre-implant, 11.8 ± 3.7 mmHg at month 1, 13.3 ± 3.6 mmHg at month 3 (p=0.35), and 11.3 ± 3.8 mmHg at 1 year (p=0.032). Mean antihypertensive medications was unchanged at month 3 (p = 1.0), and -0.36 medications at last follow-up (p = 0.35). Mean CFT change was -204 ± 158 μm (p = 0.001). There were no cases of endophthalmitis.

Conclusions::

Intravitreal steroid implants were safe and effective for the treatment of post-surgical CME in patients with pre-existing GDD. There was no increase in IOP and no increase in antihypertensive drops.

01 Jan 2025·INDIAN JOURNAL OF OPHTHALMOLOGY

Intravitreal steroid implants in the management of noninfectious intermediate and posterior uveitis

Review

Author: Prabhu, Priya ; Shah, Sarjak M ; Biswas, Jyotirmay

The management of intermediate and posterior uveitis poses a significant challenge of achieving adequate drug concentrations in the posterior segment over the chronic nature of the disease. Systemic agents seldom reach effective drug levels, and even with low maintenance or tapering doses, it is hard to avoid systemic toxicity. The use of intravitreal and periocular injections is often unable to prevent recurrences due to their short half-life. Since the emergence of intravitreal implants (Vitrasert, Retisert), it has become possible to circumvent these therapeutic challenges. A detailed review in the PubMed index yielded 155 articles, of which 22 were analyzed based on exclusion criteria. A recent shift from surgically sutured to minimally invasive injectable implants mainly indicated for noninfectious uveitis is evident from the literature. This review article also provides insights into dexamethasone (Ozurdex) and recent fluocinolone acetonide (Yutiq, Iluvien) implants with particular emphasis on their improved safety and efficacy. Dexamethasone implants favor the therapeutic goal of prevention of recurrences, whereas the use of fluocinolone implants helps to attain better visual outcomes due to their longer duration of action. Thus, the review provides recent literature supporting the role and indication of sustained release intravitreal implants in the management of noninfectious intermediate and posterior uveitis.

01 Oct 2024·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

INTRAVITREAL 0.18-mg FLUOCINOLONE ACETONIDE IMPLANT FOR PEDIATRIC UVEITIS

Article

Author: Palestine, Alan G ; Pecen, Paula E ; Pecen, Paula E. ; Reddy, Amit K. ; Palestine, Alan G. ; Jung, Jennifer L ; Jung, Jennifer L. ; Reddy, Amit K ; Wangyu, Stephanie

Purpose::

This study reports the outcomes of the 0.18-mg intravitreal fluocinolone acetonide implant in the treatment of pediatric noninfectious uveitis.

Methods::

A retrospective cohort study was performed on patients under 18 years old who received fluocinolone acetonide implant between June 1, 2020 and March 1, 2023. Data collected included demographics, uveitis diagnosis, use of anti-inflammatory therapy, visual acuity, intraocular pressure, and grading of uveitis activity. Uveitis recurrence was defined as increased inflammation that required additional anti-inflammatory therapy.

Results::

Eleven eyes from seven patients were included in this study. One patient (one eye) had a diagnosis of immune recovery uveitis and the remaining six patients (10 eyes) had pars planitis. The rate of remaining recurrence-free was 82% at 6 months, 60% at 12 months, and 60% at 24 months. Two of the six phakic eyes at baseline required cataract extraction during follow-up. Two of the four eyes that did not have intraocular pressure-lowering surgery before implantation required surgery in follow-up.

Conclusion::

The 0.18-mg fluocinolone acetonide implant has a similar efficacy for the treatment of pediatric uveitis, particularly pars planitis, as in the adult population, although with higher rates of ocular hypertension requiring intervention.

News (Medical) associated with Fluocinolone acetonide micro-insert intravitreous implant

07 Nov 2024

·www.globenewswire.com

EyePoint Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Corporate Developments

– Announced positive interim data for DURAVYU 2.7mg in DME demonstrating meaningful, early and sustained visual acuity gains, strong anatomical control and a continued favorable safety profile; BCVA and CST improvement of +8.9 letters and -68 microns, respectively, at 16-weeks – – Dosed first patient in Phase 3 LUGANO pivotal non-inferiority clinical trial of DURAVYU™ in wet AMD; second LUCIA pivotal trial first patient dosing expected by end of 2024 – – $161.0 million oversubscribed equity financing extends cash runway into 2027 - WATERTOWN, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent corporate developments. “We made tremendous progress across our pipeline in recent months, including dosing the first patient in our first global pivotal trial of DURAVYU™ in wet AMD and reading out interim 16-week data for our Phase 2 VERONA trial in DME,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint. “Driven by positive clinical data in two indications, along with growing patient and investigator enthusiasm, we remain confident that DURAVYU’s differentiated profile underscores its potential to be the first sustained-release maintenance therapy in two significant indications, positioning EyePoint as the leader in sustained ocular drug delivery. This is an exciting time for EyePoint, and we anticipate dosing the first patient in the second Phase 3 LUCIA trial by the end of 2024. With a strong balance sheet and compelling clinical data, we are well-positioned to continue executing across our pipeline, working to bring our potentially paradigm-shifting treatment to patients as fast as possible.” R&D Highlights and Updates Announced positive interim 16-week data for the ongoing open label Phase 2 VERONA clinical trial of DURAVYU for diabetic macular edema (DME) in October. DURAVYU 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in best-corrected visual acuity (BCVA) with a gain of +8.9 letters compared to baseline versus +3.2 letters for aflibercept control. DURAVYU 2.7mg also demonstrated concomitant structural improvement with CST (central subfield thickness) improvement of 68.1 microns versus 30.5 microns for aflibercept control. Notably, both DURAVYU doses showed an immediate benefit over aflibercept control in both BCVA and CST demonstrating the differentiated drug release profile of DURAVYU with immediate bioavailability. Additionally, a favorable safety and tolerability profile continued for both DURAVYU arms. The Company expects to report the full topline results in the first quarter of 2025, once all patients complete the trial.Announced first patient dosed in the Phase 3 LUGANO clinical trial of DURAVYUTM in wet age-related macular degeneration (wet AMD). The second Phase 3 LUCIA pivotal trial initiation is expected to have first patient dosing by end of 2024. The LUGANO and LUCIA clinical trials are designed for potential global regulatory and commercial success with every six-month re-dosing in both trials. With over 160 trial sites committed and robust DAVIO 2 data, the company anticipates rapid enrollment of both trials with topline data anticipated in 2026.Presented DAVIO 2 twelve-month data at the American Academy of Ophthalmology (AAO) 2024 Subspecialty Day in October, at the 24th EURetina Congress in September and the Retina Society 57th Annual Meeting in September.Presented a comparison of tyrosine kinase inhibitors being developed for intravitreal delivery at the Retina Society 57th Annual Meeting in September, demonstrating the differentiation of DURAVYU with immediate bioavailability and controlled release via zero-order kinetics for at least six months.Presented on sustained-release vorolanib highlighting selective pan-VEGF receptor inhibition and anti-angiogenic effects in VEGF-mediated ocular diseases at the American Retina Forum (ARF) 2024 National Meeting in August demonstrating the durable efficacy, reliable safety and reduced injection burden of treatment with DURAVYU. Recent Corporate Highlights Completed an underwritten public offering with gross proceeds of $161.0 million in October. The Company sold 14,636,363 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of $11.00 per share.Announced the grand opening of EyePoint’s Northbridge, MA manufacturing facility in October. The 40,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and European Medicines Agency (EMA) and will support global manufacturing across the Company’s portfolio, including lead pipeline asset, DURAVYUTM upon potential regulatory approval.Announced the appointment of esteemed industry leader Fred Hassan to the Company’s Board of Directors in September. Review of Results for the Third Quarter Ended September 30, 2024 For the third quarter ended September 30, 2024, total net revenue was $10.5 million compared to $15.2 million for the quarter ended September 30, 2023. Net product revenue for the third quarter was $0.7 million, compared to net product revenues for the third quarter ended September 30, 2023, of $0.8 million. Net revenue from royalties and collaborations for the third quarter ended September 30, 2024, totaled $9.9 million compared to $14.4 million in the corresponding period in 2023. This decrease was primarily driven by lower recognition of deferred revenue related to the out-license of YUTIQ® product rights. Operating expenses for the third quarter ended September 30, 2024, totaled $43.3 million versus $29.6 million in the prior year period. This increase was primarily driven by (i) $5.4 million in costs related to the DURAVYU™ Phase 3 clinical trials for wet AMD, (ii) $3.8 million higher personnel expense for clinical and product development, including $2.1 million of non-cash stock compensation, (iii) $3 million in other R&D related expenses. Non-operating income, net, totaled $3.4 million and net loss was $29.4 million, or ($0.54) per share, compared to a net loss of $12.6 million, or ($0.33) per share, for the prior year period. Cash and investments at September 30, 2024 totaled $253.8 million compared to $331.1 million at December 31, 2023. Financial OutlookWe expect the cash, cash equivalents and investments on September 30, 2024, along with the net proceeds from the October $161.0 million equity financing will enable us to fund operations into 2027. About EyePoint Pharmaceuticals EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in diabetic macular edema (DME). EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026. Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Forward Looking Statements EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding the timing and clinical development and potential of DURAVYU in wet AMD and DME, including our expectations regarding the announcement of full topline data from the VERONA trial in the first quarter of 2025 and initiation of the LUGANO trial and the LUCIA trial; the belief that the interim results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials; our beliefs and expectations regarding the anticipated full results from the VERONA trial; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors: Christina TartagliaPrecision AQ (formerly Stern IR)Direct: 212-698-8700christina.tartaglia@sternir.com Media Contact: Amy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)(In thousands) September 30, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $79,830 $281,263 Marketable securities 173,963 49,787 Accounts and other receivables, net 378 805 Prepaid expenses and other current assets 11,571 9,039 Inventory 2,807 3,906 Total current assets 268,549 344,800 Operating lease right-of-use assets 21,405 4,983 Other assets 10,963 5,401 Total assets $300,917 $355,184 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $21,509 $24,025 Deferred revenue 25,996 38,592 Other current liabilities 1,289 646 Total current liabilities 48,794 63,263 Deferred revenue - noncurrent 11,234 20,692 Operating lease liabilities - noncurrent 21,922 4,906 Other noncurrent liabilities 233 - Total liabilities 82,183 88,861 Stockholders' equity: Capital 1,049,180 1,007,605 Accumulated deficit (831,617) (742,146)Accumulated other comprehensive income 1,171 864 Total stockholders' equity 218,734 266,323 Total liabilities and stockholders' equity $300,917 $355,184 $— $— EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSUnaudited(In thousands, except per share data) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Revenues: Product sales, net $664 $816 $2,390 $13,483 License and collaboration agreements 9,561 14,137 27,906 17,768 Royalty income 299 249 1,389 739 Total revenues 10,524 15,202 31,685 31,990 Operating expenses: Cost of sales 736 1,202 2,896 3,634 Research and development 29,542 17,363 89,554 46,711 Sales and marketing 24 479 80 11,504 General and administrative 12,970 10,556 39,770 28,854 Total operating expenses 43,272 29,600 132,300 90,703 Loss from operations (32,748) (14,398) (100,615) (58,713)Other income (expense): Interest and other income, net 3,387 1,786 11,144 4,611 Interest expense - - - (1,247)Loss on extinguishment of debt - - - (1,347)Total other income, net 3,387 1,786 11,144 2,017 Net loss $(29,361) $(12,612) $(89,471) $(56,696)Net loss per common share - basic and diluted $(0.54) $(0.33) $(1.67) $(1.50)Weighted average common shares outstanding - basic and diluted 54,449 38,341 53,526 37,804

Clinical ResultPhase 3Phase 2Financial StatementExecutive Change

16 Sep 2024

·www.globenewswire.com

ANI Pharmaceuticals, Inc. Completes Acquisition of Alimera Sciences

Strengthens Rare Disease segment as largest driver of future growth, adding approximately $105 million in 2024 revenue on a pro forma basisAdds two durable commercial assets ILUVIEN® and YUTIQ® with significant growth potential, expanding ANI’s foothold in strategic therapeutic area of ophthalmologyAnticipated to drive high single-digit to low double-digit accretion in adjusted non-GAAP EPS in 2025 and to be substantially accretive thereafterNew capital structure in place, reducing interest expense by approximately $39 million on an annualized basis (1)ANI maintains its 2024 financial guidance for the standalone Company based on continued momentum across Purified Cortrophin® Gel (Cortrophin Gel) and Generics PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or “the Company”) (Nasdaq: ANIP) today announced the completion of its previously announced acquisition of Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”). Nikhil Lalwani, President and CEO of ANI, stated, “Today marks a major milestone in our strategy to expand our Rare Disease business and deliver on our purpose of ‘Serving Patients, Improving Lives.’ Alimera is highly synergistic to our Rare Disease business, and we believe our proven commercial execution capabilities can further unlock the value of ILUVIEN and YUTIQ, two growing and durable assets, as well as accelerate the growth of Cortrophin Gel in ophthalmology. We continue to expect the transaction to create substantial shareholder value and generate high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS with substantially higher accretion thereafter.” “With this acquisition, ANI now has three commercial rare disease assets, an expanded global footprint, and a robust Rare Disease team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology. I want to thank the employees of both companies and our advisors for their cooperation and diligence in closing this transformational transaction. We are thrilled to welcome Alimera to the ANI team,” concluded Lalwani. Stephen Carey, Senior Vice President and Chief Financial Officer of ANI said, “ANI’s new capital structure provides us significant financial flexibility to support the integration of Alimera and continue investing in organic growth initiatives while also significantly reducing our interest expense and increasing cash flow.” ________________________(1) As compared to estimated interest expense that would have been incurred if the new principal amount of debt was subject to rates that would have applied under the previous debt capital structure Transaction Rationale Solidifies Rare Disease segment as the largest driver of future growth: The combination with Alimera creates an attractive Rare Disease growth platform, adding approximately $105 million in 2024 revenue on a pro forma basis and expanding the Rare Disease segment to approximately 45% of pro forma 2024 revenues. The transaction also expands ANI’s footprint beyond the U.S. to 20 countries in Europe and beyond. Adds two durable commercial products with significant growth potential that leverage the Company’s existing Rare Disease infrastructure: ILUVIEN and YUTIQ are durable assets with high barriers to genericization which the Company believes have a clear role for patients in need of alternative therapeutic options. ANI sees the potential to unlock significant additional growth for both ILUVIEN and YUTIQ through commercial synergies and execution.Expands foothold in ophthalmology and expected to accelerate growth of Cortrophin Gel in this key therapeutic area: During the first quarter of 2024, ANI launched a targeted ophthalmology-focused sales force for Cortrophin Gel. The team has continued to gain momentum in ophthalmology, driving significant growth in the number of new patient starts in the second quarter and third quarter to date. Importantly, the addition of Alimera expands the reach of the ophthalmology sales team to over 3,600 physicians. The Company estimates that there is over 50% overlap between high potential prescribers of Cortrophin Gel, ILUVIEN and YUTIQ.Offers potential for substantial shareholder value creation: ANI continues to expect high single-digit to low double-digit accretion in 2025 adjusted non-GAAP EPS with substantial accretion thereafter. The transaction is anticipated to deliver an additional $35 - $38 million in 2025 adjusted non-GAAP EBITDA inclusive of approximately $10 million in identified cost synergies with additional EBITDA contribution expected from accelerated growth of Cortrophin Gel within ophthalmology. Business Updates Cortrophin Gel: ANI continues to see momentum across all targeted specialties and prescription growth across both existing and new prescribers. In August, the Cortrophin Gel franchise experienced a record number of new patients starts and the Company believes there is significant room for future growth as the number of patients on ACTH therapy remains significantly lower it was than a few years ago.Generics: Strong R&D capabilities enabled ANI to launch four products in the third quarter to date, bringing the number of products launched year-to-date to fourteen. In addition, the Company’s operational excellence leveraging its U.S. based manufacturing footprint and a robust FDA compliance track record continues to enable ANI to deliver high-single-digit to low double-digit growth in Generics.Alimera Integration: ANI has made substantial progress on integration planning and expects the combined ophthalmology commercial team to begin generating synergies across Cortrophin Gel, ILUVIEN and YUTIQ in the near-term. The Company will leverage its manufacturing, quality, and regulatory expertise to further strengthen supply-security for ILUVIEN and YUTIQ.Guidance: ANI is maintaining its 2024 guidance for the standalone Company based on continued momentum across Cortrophin Gel and Generics and plans to provide 2024 guidance for the combined Company by no later than the Company’s third quarter earnings call. Terms of the Transaction Under the terms of the merger agreement, ANI acquired all of the outstanding shares of Alimera for $5.50 per share. The Company also repaid $72.5 million of Alimera debt. Alimera investors received one non-tradable contingent value right (CVR) representing the right to receive up to $0.50 per share upon the achievement of certain net revenue targets in 2026 and 2027. New Capital Structure ANI recently completed an offering of $316.25 million aggregate principal amount of 2.25% convertible senior notes due September 1, 2029. The Company utilized a majority of the net proceeds as well as cash from its balance sheet to repay in full its existing senior secured term loan facility ($292.5 million that carried an interest rate of SOFR+6.0%). The initial conversion price of the convertible notes is $74.11 per share. Concurrent with the convertible offering, the Company used $40.6 million of the net proceeds to enter into capped call transactions. The cap price of the capped call transactions is initially $114.02 per share, which represents a premium of 100% over the last reported sale price of the Company’s common stock on August 7, 2024. The capped call transactions are expected generally to reduce the potential dilution to ANI’s common stock upon any conversion of the notes up to the cap price of $114.02.To fund the acquisition of Alimera, ANI entered into a new senior secured credit agreement consisting of a $325 million delayed draw term loan facility and $75 million revolving credit facility (initial interest rate SOFR+2.75%). On September 16, 2024 the Company drew the full $325 million term loan; the $75 million revolving credit facility remains un-drawn.The Company expects these capital structure changes to reduce interest expense by approximately $39 million on an annualized basis as compared to estimated interest expense that would have been incurred if the new principal amount of debt was subject to rates that would have applied under the previous debt capital structure. Advisors Guggenheim Securities, LLC acted as lead financial advisor to ANI and Raymond James & Associates, Inc. also acted as financial advisor. Hughes Hubbard & Reed LLP acted as legal advisor to ANI. Centerview Partners LLC acted as lead financial advisor to Alimera, and Perella Weinberg Partners also acted as a financial advisor to Alimera. DLA Piper acted as legal advisor to Alimera. About ANI Pharmaceuticals, Inc. ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. ANI is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint. Forward-Looking Statements This press release contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s expectations or beliefs concerning future events, including statements regarding the benefits of the acquisition of Alimera Sciences. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “continue,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “shall,” “would” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the ability to implement business plans, forecasts, and other expectations in connection with the acquisition and integration of Alimera Sciences, and identify and realize additional opportunities and, in particular, the possibility that the Company is unable to achieve anticipated synergies, (ii) costs and regulatory requirements relating to contract manufacturing arrangements, (iii) costs or delays associated with manufacturing (including the sources and any changes in sources thereof) of the Company’s products, (iv) delays or failures in retaining and obtaining continuing and future product approvals from the FDA, and other regulatory issues relating to the Company's business and products, (v) market trends for the Company’s products, including but not limited to, ILUVIEN, YUTIQ and Cortrophin Gel, and the ability to achieve anticipated sales for such products, (vi) risks that the acquisition of Alimera may disrupt current plans and operations of the Company and potential difficulties of the Company in retaining employees of Alimera and/or maintaining business relationships of Alimera, (vii) the impact of any litigation to which the Company is, or may become, a party, including in connection with the acquisition and integration thereof, (viii) volatility in the Company’s stock price, including as a result of the acquisition, (ix) changes in competitive and regulated industries in which the Company operates, variations in operating performance across competitors, changes in laws and regulations affecting the Company’s business, and changes in the Company’s capital structure as a result of the acquisition, (x) regulatory and other approvals relating to product development and manufacturing, (xi) the Company’s ability, and that of its suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries and/or the Company and its products, (xii) costs incurred in connection with the acquisition of Alimera and the possibility that the Company is unable to realize anticipated benefits of the acquisition or to realize estimated pro forma results and underlying assumptions, (xiii) delays in production, increased costs and potential loss of revenues if there is a change in manufacturers or manufacturing processes due to the limited number of suppliers for the Company’s raw materials, active pharmaceutical ingredients, excipients and other materials, (xiv) the Company’s reliance on single source third-party contract manufacturing supply for certain of its key products, including ILUVIEN, YUTIQ and Cortrophin Gel, (xv) changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration, and other regulatory agencies, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions, (xvi) the impact of legislative or regulatory reform on the pricing for the Company’s products, (xvii) the Company’ ability to maintain the services of its key executives and other personnel, and (xviii) general business and economic conditions, such as inflationary pressures, geopolitical conditions including, but not limited to, the conflict between Russia and the Ukraine, the conflict between Israel and Gaza, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies. This press release refers to financial measures that are not in accordance with U.S. generally accepted accounting principles (“GAAP”). Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to or as a substitute for the related financial measures that are prepared in accordance with GAAP and are not intended to be considered in isolation and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. A reconciliation of the forward-looking non-GAAP measures presented in this communication is not provided due to the inherent difficulty in forecasting and quantifying items that are necessary for such reconciliation. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The variability of the specified items may have a significant and unpredictable impact on future financial performance. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this communication. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com

Acquisition

27 Aug 2024

·www.fiercepharma.com

EyePoint dinged with FDA warning letter over manufacturing shortfalls tied to eye implant

An EyePoint spokesperson told Fierce that the issues raised in the FDA's warning letter are confined to the manufacturing of Yutiq and should not affect other products under development, such as the company’s lead candidate Duravyu. After hitting a regulatory snare with its lead drug candidate earlier this year, ophthalmology specialist EyePoint Pharmaceuticals has run up against another spot of trouble with the FDA.EyePoint was handed an FDA warning letter at its facility in Watertown, Massachusetts, in July, according to a notice from the agency posted Tuesday. EyePoint received the more serious reprimand after previous receipt of a Form 483, which the company responded to March 7.The FDA’s citations, uncovered during a February inspection, include batch discrepancies, lackluster written procedures and more.Many of the regulator’s complaints come down to the EyePoint-developed implant Yutiq, which contains the corticosteroid fluocinolone acetonide. EyePoint recently sold certain rights for the drug-device combo—which was approved in the U.S. in 2018—to Alimera Sciences in an $82.5 million deal. With an emphasis on quality and safety, EyePoint is “committed to fully resolving” all of the FDA’s observations, a company spokesperson told Fierce Pharma over email. She pointed out that the issue is confined to the manufacturing of Yutiq and should not affect other products under development, such as the company’s lead candidate Duravyu.“EyePoint has been communicating with the FDA regarding actions it has taken and is taking to address findings identified in the Warning Letter, and we have applied resources from across the company to implement corrective actions and process improvements related to the observations,” she said.The FDA’s first complaint on EyePoint’s manufacturing operations revolved around the company’s failure to root out production inconsistencies. Agency investigators chided EyePoint for failing to investigate an atypically high release rate value for drug cores during the release testing of a particular Yutiq batch.Further, EyePoint’s own probes failed to identify proper solutions to keep its manufacturing on track, the FDA said. The regulator pointed to “three roof leaks,” which caused moisture to seep into “environmentally controlled manufacturing areas”—a problem that the investigators said stretched back to July 2023.EyePoint told the FDA it would work with the owner of the building to assess the space’s roof. But the company did not establish regular facility inspections to confirm an “appropriate state of maintenance and continued suitability to manufacture drug products,” the FDA said.EyePoint has also struggled with written procedures at its Watertown plant, the FDA went on to say.The FDA specifically called out subpar performance studies of Yutiq that “did not scientifically demonstrate blend uniformity” in the final product.Additionally, EyePoint’s operations and engineering organizations failed to create statistical process control charts to keep track of the company’s manufacturing procedure performance. The various charts that EyePoint only generated during the FDA’s inspection “identified four previously unrecognized adverse trends … that required investigation per your procedure,” the FDA stated in its warning letter.Lastly, the FDA scolded EyePoint for subpar visual inspections during its production process, noting that the company’s methodology “lack[ed] action levels for significant … defects which will require investigation.”The regulatory wrist slap comes after EyePoint in May reported that its primary pipeline asset, Duravyu, failed to sufficiently improve patient scores on the Diabetic Retinopathy Severity Scale. The trial miss came from EyePoint’s phase 2 PAVIA study in patients with non-proliferative diabetic retinopathy.At the time, Mizuho analyst Graig Suvannavejh, Ph.D., called the result a “significant disappointment” for EyePoint and said he expected “questions to rise to the surface” regarding Duravyu’s prospects in diabetic macular edema and wet age-related macular degeneration (AMD), which are also being targeted by the company.Duravyu is an intravitreal, sustained release insert that delivers the VEGFR/PDGFR tyrosine kinase inhibitor vorolanib to the eye. EyePoint licensed vorolanib from Equinox Science in early 2020.Despite a few hiccups for EyePoint this year, Mizuho’s Suvannavejh seemed more optimistic about the company by the middle of August. In a recent note to clients, Suvannavejh wrote that the analyst team still has “continued enthusiasm” around EyePoint given the ripe potential for Duravyu in wet AMD, where the implant could become a standard of care.EyePoint stressed during its second-quarter earnings call that executing on Duravyu’s phase 3 study in wet AMD was its top priority, according to the Mizuho note.

Phase 3Drug ApprovalPhase 2Clinical Result

100 Deals associated with Fluocinolone acetonide micro-insert intravitreous implant

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	C05AA10 S02BA08 S01BA15	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Uveitis	US	EyePoint Pharmaceuticals, Inc.	12 Oct 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-infectious posterior uveitis	Phase 3	US	EyePoint Pharmaceuticals, Inc.	02 Aug 2013
Non-infectious posterior uveitis	Phase 3	DE	EyePoint Pharmaceuticals, Inc.	02 Aug 2013
Non-infectious posterior uveitis	Phase 3	HU	EyePoint Pharmaceuticals, Inc.	02 Aug 2013
Non-infectious posterior uveitis	Phase 3	IN	EyePoint Pharmaceuticals, Inc.	02 Aug 2013
Non-infectious posterior uveitis	Phase 3	IL	EyePoint Pharmaceuticals, Inc.	02 Aug 2013
Non-infectious posterior uveitis	Phase 3	GB	EyePoint Pharmaceuticals, Inc.	02 Aug 2013
Diabetic macular oedema	Phase 2	US	Eclipse Life Sciences, Inc.	19 Aug 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EURETINA2023	Not Applicable	Diabetic macular oedema	-	0.19 Fluocinolone Acetonide Implant (NVG)	naiasbelsu(kqmzrwmknf) = BCVA was maintained from baseline to last study visit (+5.4 Letters; NS) gsanzksann (akidtizaul ) View more	-	05 Oct 2023
EURETINA2022	Not Applicable	-	-	0.19 mg FAc implant	alscuejhhq(oxosiyggau) = cxukuuigbc ceslerzurr (ssnsggaedf ) View more	-	01 Sep 2022
				Steroid challenge	egwlqafptj(larkvqdias) = cpopylmrhi izjmxkusen (obqgzrrpvw )
NCT01694186 (FAI, CTgov)	Phase 3	Non-infectious posterior uveitis	129	Sham injection (Sham Injection)	ekixtccmjb(qbjpfjktdc) = brnoqdaeoh mktvmdxews (rjaldukpak, cpshcjuvao - xbnwiojrjq) View more	-	23 Mar 2020
				FAI insert (FAI Insert)	ekixtccmjb(qbjpfjktdc) = etrojmyxgb mktvmdxews (rjaldukpak, geszjbzxsz - ymclgyyznd) View more
ICE-UK study (ARVO2019)	Not Applicable	Diabetic macular oedema	149	Fluocinolone acetonide (FAc) intravitreal implant	afrihapttn(xsallezkvr) = lpalseuyde fnluxcujqs (hqqpiqkwpz ) View more	-	01 Jul 2019
NCT01694186 (Pubmed) Manual	Phase 3	Uveitis	129	Fluocinolone Acetonide (FA insert)	gafqfffrzw(sapmkwnyff) = nthdjiodnd jugtmzmdvw (pmoqefetxg ) View more	Positive	01 Apr 2019
				Placebo (sham injection)	gafqfffrzw(sapmkwnyff) = nlyweyibfz jugtmzmdvw (pmoqefetxg ) View more
ARVO2018	Not Applicable	Diabetic macular oedema	6	Intravitreal Fluocinolone Acetonide Implant	kdytupbusc(xberasenzy) = jhnerpcgek sjssnvrizy (gfmfwtociv, 15.9)	-	01 Jul 2018
NCT01996748 (CTgov)	Phase 3	Eczema	135	DF277 (DF277)	jmfpwcxwvl(atfdcylpuj) = yfzikbwaxt ziolzkjezn (tlfnlhbeyd, ymkpmgkxld - cyuijvypkp) View more	-	14 Apr 2017
				Placebo (Placebo)	jmfpwcxwvl(atfdcylpuj) = ipepgqgtfb ziolzkjezn (tlfnlhbeyd, gzilahrnnv - htzjilabya) View more
ARVO2013	Not Applicable	Uveitis, Posterior	-	FLUOCINOLONE ACETONIDE (Aqueous nanomicellar formulation with modified TPGS)	zsjqjnesof(jaodzhyakt) = huvmqaccdp drzjewiych (ckxwqjtjlz ) View more	-	01 Jun 2013
				FLUOCINOLONE ACETONIDEPEG (Aqueous nanomicellar formulation with PEG 2000)	hsxduqwclf(mcbflarbbg) = blxgptaehl azijqmfrlt (ielqzdvepl ) View more

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